Terapias psicológicas para el tratamiento del dolor crónico y recurrente en niños y adolescentes
Referencias
Referencias de los estudios incluidos en esta revisión
Referencias de los estudios excluidos de esta revisión
Referencias adicionales
Referencias de otras versiones publicadas de esta revisión
Characteristics of studies
Characteristics of included studies [ordered by study ID]
Ir a:
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment (3‐month follow‐up), 6 months | |
| Participants | End of treatment: n = 50 Start of treatment: n = 81 Sex: 45 F, 36 M Mean age = 12.7 years (range 10 to 18) Source = hospital and clinic Diagnosis = headache Mean years of pain = not given | |
| Interventions | "Headache Clinical Model: behavioural intervention" "Headache Traditional Model: consultation with neurologist" | |
| Outcomes | Primary pain outcome: none Primary disability outcome: Ped‐MIDAS Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not reported Funding: "This study was funded by the Nemours Clinical Management Program, Orlando, FL." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "If the family was interested in the study, they were randomised (using a random number table) to either a TCM appointment or a HCM appointment." |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described, however no significant differences between completers and non‐completers were reported |
| Selective reporting (reporting bias) | High risk | Data were incompletely reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment and 1‐year follow‐up | |
| Participants | End of treatment: n = 48 Start of treatment: n = 48 Sex: 35 F, 12 M Mean age = 9.5 years (range 6 to 18) Source = hospital Diagnosis = recurrent abdominal pain Mean years of pain = 2.3 | |
| Interventions | "Psychological treatment and physiotherapy" "Physiotherapy alone" | |
| Outcomes | Primary pain outcome: pain score Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: "No conflict of interest...exists." Funding: "No...funding exists." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "The children recruited during 1996–1999 were randomised" |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts reported |
| Selective reporting (reporting bias) | High risk | Data were incompletely reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment and 12 months | |
| Participants | End of treatment: n = 42; follow‐up 1 year: n = 34 Start of treatment: n = 42 Sex: 12 F, 15 M Mean age = 14.17 years (1.75) Source = sickle cell centre Diagnosis = sickle cell disease Mean years of pain = lifetime | |
| Interventions | "Pain Management Intervention" | |
| Outcomes | Primary pain outcome: pain diary Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not reported Funding: "This research was funded by National Heart, Lung, and Blood Institute (U54 30117 to J.R.)." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "A 2‐group, randomised treatment design was used." |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described; no significant differences between completers and non‐completers were reported |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment, 3 months | |
| Participants | End of treatment: n = 29 Start of treatment: n = 36 Sex: 19 F, 10 M Mean age = 9.4 years Source = volunteers via school and primary healthcare settings; referrals invited from primary and secondary care Diagnosis = headache Mean years of pain not given | |
| Interventions | "Cognitive behaviour therapy" | |
| Outcomes | Primary pain outcome: headache intensity Primary disability outcome: school absence Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not described Funding: not described | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Each parent‐child pair was initially matched with another pair based on the child's age, sex and headache pain as indicated by the parents' ratings of average duration, frequency, and intensity of headaches. Subsequently, one of each of the matched parent‐child pairs was randomly assigned to either the treatment condition or the waiting‐list control condition." |
| Allocation concealment (selection bias) | High risk | "Each parent‐child pair was initially matched with another pair based on the child's age, sex and headache pain as indicated by the parents' ratings of average duration, frequency, and intensity of headaches. Subsequently, one of each of the matched parent‐child pairs was randomly assigned to either the treatment condition or the waiting‐list control condition." |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described; no significant differences between completers and non‐completers were reported |
| Selective reporting (reporting bias) | Unclear risk | Data were completely reported on request |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment, 6 months, 12 months | |
| Participants | End of treatment: n = 35 Start of treatment: n = 35 Sex: 17 F, 18 M Mean age = 11.4 years (range 11 to 15) Source = specialised headache clinic Diagnosis = headache Mean years of pain (mean) = 2.6 | |
| Interventions | "Biofeedback (assisted relaxation)" "Relaxation" | |
| Outcomes | Primary pain outcome: Pain Index Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: State Trait Anxiety Index
| |
| Notes | COI: not reported Funding: "Preparation of this research was supported in part by a research grant from the National Institute of Nuerological Disorders and Stroke, NS‐29855." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Patients were randomly assigned to one of two experimental conditions" |
| Allocation concealment (selection bias) | High risk | "... with the constraint that subjects be over‐sampled in BFB‐REL treatment (2:1 ratio) in order to make actual treatment available to as many children as possible." |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts reported in study |
| Selective reporting (reporting bias) | High risk | Data incompletely reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment and post‐treatment. | |
| Participants | End of treatment: n = unknown Start of treatment: n = 90 Sex: 52 F, 38 M Mean age = 11.6 years (SD = 2.0; range 8 to 12) Source = unknown Diagnosis = migraine Mean years of pain (range) = 1 to 4 years | |
| Interventions | "Standard treatment (0.2 mg/kg of oral flunarizine) + Behavior therapy" "Standard treatment" (0.2 mg/kg of oral flunarizine)" | |
| Outcomes | Primary pain outcome: Headache frequency Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: none stated Funding: none stated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "We adapt prospective randomized controlled study method, where the 90 patients (children) were randomized to control group and treatment group." Comment: unclear randomization procedure |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | High risk | Attrition in the study was not described |
| Selective reporting (reporting bias) | High risk | Not all data was included in the paper |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment, and 8 months | |
| Participants | End of treatment: n = 30, follow‐up n = 28 | |
| Interventions | "STOP Migraines treatment" ‐ behavioural treatment delivered via telephone | |
| Outcomes | Primary pain outcome: none Primary disability outcome: hours disabled by headache Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | Funding source: National Institutes of Health (NINDS #N32374) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Thus, 34 adolescents were randomized to treatment (16 TT and 18 TAT)." |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition completely reported; significant differences between completers and non‐completers were not reported |
| Selective reporting (reporting bias) | High risk | Outcomes incompletely reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed pretreatment and post‐treatment (6 months) | |
| Participants | End of treatment: n = 62 Start of treatment: n = 83 Sex of children: 42 M, 41 F Mean age of children = 8.48 years (± 2.11) Source = two comprehensive sickle cell clinics in children’s hospitals Diagnosis = sickle cell disease Mean years of illness = lifetime | |
| Interventions | "Families Taking Control" (PSST) "Delayed Intervention Control" | |
| Outcomes | Primary pain outcome: none Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: "Conflicts of interest: None declared." Funding: "NHLBI (U54 HL070585) to M.S. (PI), BTRP to LPB (PI); and NCMHD (1RC1MD004418) to L.P.B. (PI)." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomization (stratified by gender in blocks of 10) was concealed from the family and the study team until after completing the baseline assessment when an envelope with randomization status was opened and the family was informed of next steps." Comment: insufficient information about the sequence generation process to permit judgement |
| Allocation concealment (selection bias) | Unclear risk | "Randomization (stratified by gender in blocks of 10) was concealed from the family and the study team until after completing the baseline assessment when an envelope with randomization status was opened and the family was informed of next steps." Comment: insufficient information about allocation concealment provided to permit judgement; it was unclear if envelopes were sequentially numbered, opaque, and sealed |
| Blinding of outcome assessment (detection bias) | Unclear risk | Insufficient information to permit judgement; no statement about whether or not blinding of outcome assessment occurred |
| Incomplete outcome data (attrition bias) | Low risk | Attrition was reported, no significant differences between completers and non‐completers were reported |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment | |
| Participants | End of treatment: n = 32 Start of treatment: n = 32 Sex: 22 F, 10 M Mean age = 9.1 years (SD 2.1) Source = paediatric gastroenterology service Diagnosis = recurrent abdominal pain Mean years of pain = 2.1 | |
| Interventions | "Cognitive behavioural family intervention" "Standard paediatric care, 4 sessions" | |
| Outcomes | Primary pain outcome: pain intensity VAS Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not reported Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomly allocated to 2 groups." |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts were reported in the study |
| Selective reporting (reporting bias) | High risk | Data were incompletely reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment, 8 to 12 months | |
| Participants | End of treatment: n = 36 Start of treatment: n = 36 Sex: 25 F, 11 M Mean age = 15.4 years (range 13 to 18) Source = school Diagnosis = headache Mean years of pain = not given | |
| Interventions | "Relaxation" "waiting‐list control" | |
| Outcomes | Primary pain outcome: total headache score Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not reported Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "The subjects were randomly assigned to the relaxation treatment or waiting‐list groups" |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts were reported in the study |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment | |
| Participants | End of treatment: n = 49 Start of treatment: n = 49 Sex: 23 F, 26 M Mean age = 11.9 years Source = university medical centre, sickle cell centre Diagnosis = sickle cell anaemia (SS), sickle cell disease (SC), sickle beta thalassaemia Mean years of pain = not given | |
| Interventions | "Cognitive coping skills" "Standard care control" | |
| Outcomes | Primary pain outcome: none Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not reported Funding: "This work was supported by Grant RO1 HL46953‐06, by Project VI.B.2 in the Duke University‐University of North Carolina Sickle Cell Center Grant in P60HL2839‐13, and by the University of North Carolina at Chapel Hill GCRC Grant RR00046." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Participants were then randomly assigned to one of two conditions." |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts reported in study |
| Selective reporting (reporting bias) | High risk | Data not fully reported |
| Study characteristics | ||
| Methods | RCT. 3 Arms. Assessed pretreatment, after initial treatment (12 weeks), after additional treatment (20 weeks) | |
| Participants | End of treatment (12 weeks): n = 65; end of treatment (20 weeks): n = 65 | |
| Interventions | "PSST IBD" | |
| Outcomes | Primary pain outcome: none Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | Funding: "Supported by the Crohn’s and Colitis Foundation of America (Senior Research Award #2838; PI: Greenley)." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The randomization sequence was generated by a biostatistician using Windows version 6.0 of randomization program 'Rand.exe.'" Comment: probably done |
| Allocation concealment (selection bias) | Low risk | "The random allocation sequence was stored electronically in a password‐protected file accessible only to the research assistant in charge of informing participants of randomization outcomes. Research assistants enrolling participants and those conducting assessment visits were blind to participant intervention condition." Comment: probably done |
| Blinding of outcome assessment (detection bias) | Low risk | "All assessments were conducted in participants' homes...Research assistants...conducting assessment visits were blind to participant intervention condition." Comment: probably done |
| Incomplete outcome data (attrition bias) | Low risk | Attrition was reported but differences between completers and non‐completers are not reported |
| Selective reporting (reporting bias) | Unclear risk | All data reported |
| Study characteristics | ||
| Methods | RCT. 3 arms. Assessed at pretreatment, post‐treatment and 9 weeks post‐treatment | |
| Participants | End of treatment: n = 42; follow‐up: n = 42 Start of treatment: n = 51 Sex: 21 F, 21 M Mean age = 11.3 years Source = not known Diagnosis = migraine Mean years of pain = not given: minimum 6 months | |
| Interventions | "Cognitive behavioural therapy (clinic‐based)" (n = 15) | |
| Outcomes | Primary pain outcome: headache index Primary disability outcome: none Primary depression outcome: Child Depression Scale Primary anxiety outcome: Child Manifest Anxiety Scale (CMAS)
| |
| Notes | COI: not reported Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "It was decided to assign children to groups by true randomisation rather than on the basis of headache diagnosis" |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | High risk | Attrition was not described |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed pretreatment, post‐treatment and at 3 months | |
| Participants | End of treatment: n = 28; follow‐up: n = 28 Start of treatment: n = 29 Sex: 25 F, 4 M Mean age = 9.6 years (SD = 1.47) Source = schools Diagnosis = chronic abdominal pain Mean years of pain = 2.8 years (SD = 1.71) | |
| Interventions | "Stop the pain with Happy Pingu" CBT "Wait‐list control" | |
| Outcomes | Primary pain outcome: pain intensity Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: "There are no conflicts of interest." Funding: "This work was supported by a grant to M. G. of Potsdam Graduate School." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Computer‐aided randomization was performed by a person who was not involved in the study" |
| Allocation concealment (selection bias) | Low risk | "Computer‐aided randomization was performed by a person who was not involved in the study" |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described; differences between completers and non‐completers were not described |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed pretreatment, post‐treatment (3 months) | |
| Participants | End of treatment: n = 37 Start of treatment: n = 38 Sex: 24 F, 14 M Mean age = 9.4 years (SD = 1.72) Source = adverts in local newspapers and paediatricians' offices Diagnosis = functional abdominal pain or irritable bowel syndrome Mean years of pain = 34.84 months (SD = 40.7) | |
| Interventions | "Hypnotherapeutic therapy" (hypnotherapeutic and behavioural methods) "Wait‐list control group" | |
| Outcomes | Primary pain outcome: mean pain intensity Primary disability outcome: Paediatric Pain Disability Index Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: "The authors declare that they have no conflict of interest." Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Families were randomly assigned following simple randomization procedures (computerized random number generator)" |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described; differences between completers and non‐completers were not described |
| Selective reporting (reporting bias) | Low risk | Data fully reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed pretreatment, post‐treatment, 6 months, and 12 months | |
| Participants | End of treatment: n = 108 Start of treatment: n = 120 Sex: 87 F, 27 M Mean age = 14 years (SD 2.85) Source = clinic Diagnosis = chronic pain (mixed conditions) Mean years of pain = median of 18 months (intervention group) and 13.5 months (control group) | |
| Interventions | "Intensive interdisciplinary pain treatment" "Wait‐list control" | |
| Outcomes | Primary pain outcome: mean pain intensity Primary disability outcome: Paediatric Pain Disability Index Primary depression outcome: Depression Inventory for Children and Adolescents (DIKJ) Primary anxiety outcome: Pain‐Related Cognitions Questionnaire for Children (catastrophising subscale)
| |
| Notes | COI: "The authors declare no conflict of interest." Funding: "The present study was supported in part by the Robert Bosch Foundation GmbH (Grant 11.5.1344.0010.0). The Robert Bosch Foundation was not involved in (1) the study design; (2) collection, analysis, and interpretation of data; (3) the writing of the report; and (4) the decision to submit the paper for publication." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomisation was conducted with a 1:1 approach and in blocks of 4 and blocks or 6 for both groups and was stratified for gender" |
| Allocation concealment (selection bias) | Low risk | "The individual who carried out the randomization procedure was blinded to the treatment condition" |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described; differences between completers and non‐completers were not described |
| Selective reporting (reporting bias) | Unclear risk | Data fully reported on request |
| Study characteristics | ||
| Methods | RCT. Two arms. Assessed pretreatment and post‐treatment. | |
| Participants | End of treatment: n = 32 Start of treatment: n = 36 Sex: 87 F, 27 M Mean age = 14 years (SD 2.85) Source = clinic Diagnosis = chronic pain (mixed conditions) Mean years of pain = unknown | |
| Interventions | "COPE‐HEP; Creating Opportunities for Personal Empowerment ‐ Headache Education Program" "Treatment‐as‐usual" | |
| Outcomes | Primary pain outcome: none Primary disability outcome: Ped‐MIDAS Primary depression outcome: Beck Youth Inventory II, Depressive symptoms Primary anxiety outcome: Beck Youth Inventory II, Anxiety symptoms
| |
| Notes | COI: The authors report no financial incentives that may create a conflict of interest." Funding: "This research was supported by a grant from the National Institute of Nursing Research/National Institutes of Health (1F31NR012112‐01A1)." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Adolescents were randomized to the COPE‐HEP intervention or a comparison headache education group." Comment: no method described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was reported but differences between completers and non‐completers were not described |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported |
| Study characteristics | ||
| Methods | RCT. 4 arms. Assessed at pretreatment, post‐treatment | |
| Participants | End of treatment: n = 61 Start of treatment: n = 64 Sex: 38 F, 26 M Mean age = 9.8 years (SD 2.5) Source = advertisement and physician referral Diagnosis = recurrent abdominal pain Mean years of pain = none given | |
| Interventions | "CBT + biofeedback + parental support + fibre" "CBT + biofeedback + fibre" "Biofeedback + fibre" "Fibre" | |
| Outcomes | Primary pain outcome: pain diary Primary disability outcome: school attendance Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: none stated.Funding: none stated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Patients were randomly assigned to one of the four groups" |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | High risk | Attrition not described; significant differences between completers and non‐completers not reported |
| Selective reporting (reporting bias) | Low risk | Data fully reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment (week 8), 6 weeks | |
| Participants | End of treatment: n = 27 Start of treatment: n = 30 Sex: 30 F, 0 M Median age = 15.8 years (SD 1.3) Source = paediatric rheumatology clinic of a children's hospital Diagnosis = juvenile primary fibromyalgia (JPFM criteria; Yunus) Mean years of pain = 19 for > 2 years, 11 for 6 months to 2 years | |
| Interventions | "Coping skills training" "Self‐monitoring" | |
| Outcomes | Primary pain outcome: average pain VAS Primary disability outcome: Functional Disability Inventory Primary depression outcome: Children's Depression Inventory Primary anxiety outcome: none
| |
| Notes | COI: not reported Funding: "Supported by grants from the Cincinnati Children’s Hospital Research Foundation and National Institutes of Health Grant 1P60AR47784‐01." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "A computer generated pseudo‐random number list was used. A simple randomisation technique was used with a 1:1 allocation ratio for 30 subjects as a single block." |
| Allocation concealment (selection bias) | Low risk | "A computer generated pseudo‐random number list was used. A simple randomisation technique was used with a 1:1 allocation ratio for 30 subjects as a single block." |
| Blinding of outcome assessment (detection bias) | Low risk | "A research assistant who was blind to the study objectives and to the subjects' treatment assignment administered the self‐report measures. The rheumatologist or occupational therapist who conducted the tender point assessments was blind to the subjects' treatment assignment." |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition is described, however significant differences between completers and non‐completers were not reported |
| Selective reporting (reporting bias) | Low risk | Data were fully reported on request for additional data |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed pretreatment, post‐treatment, 6‐month follow‐up | |
| Participants | End of treatment: n = 106; follow‐up 6 months n = 100 Start of treatment: n = 114 Sex: 105 F, 9 M Mean age = 15.0 years (1.8) Source = paediatric rheumatology centres in Midwestern USA Diagnosis = fibromyalgia syndrome Mean years of pain = 2 years, 10 months (2 years, 6 months) | |
| Interventions | "Cognitive behavioural therapy" | |
| Outcomes | Primary pain outcome: pain severity VAS (averaged over 7 days) Primary disability outcome: Functional Disability Scale Primary depression outcome: Children's Depression Inventory Primary anxiety outcome: Pain Coping Questionnaire
| |
| Notes | COI: "Dr. Passo has received consulting fees, speaking fees, and/or honoraria from Pfizer (less than $10,000)." Funding: "Supported by the NIH (National Institute of Arthritis and Musculoskeletal and Skin Diseases grant R01‐AR‐050028 to Dr. Kashikar‐Zuck)." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Eligible patients were randomly assigned to 1 of the 2 treatment arms based upon a computer‐generated randomisation list. Randomisation was stratified by site." |
| Allocation concealment (selection bias) | Low risk | "When a patient was enrolled, the study therapist contacted the biostatistician to obtain the subject identification number and treatment allocation." |
| Blinding of outcome assessment (detection bias) | Low risk | "The principal investigator, study physicians, study coordinator, and assessment staff were all blinded to the patients' treatment condition throughout the trial. Patients were asked not to divulge what treatment they were receiving to the study physician." |
| Incomplete outcome data (attrition bias) | Low risk | Attrition was described; no significant differences between completers and non‐completers were reported |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |
| Study characteristics | ||
| Methods | RCT. 3 arms. Assessed at pretreatment, post‐treatment, 6 months | |
| Participants | End of treatment: n = 75 Start of treatment: n = 78 Sex: 35 F, 40 M Mean age = 12.1 years (SD 1.3) Source = newspaper advertisement ‐ 2 or more headaches per month reported by parents Diagnosis = paediatric headache: migraine (30%), tension‐type (40%), combined (30%) Mean years of pain = 4.0 (SD 2.6) | |
| Interventions | "Cognitive behavioural training group" (n = 29) "Self‐help" (n = 27) "Waiting‐list control" (n = 19) | |
| Outcomes | Primary pain outcome: pain intensity Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not reported Funding: "The study was supported by a grant from the Technician’s Health Care Insurance of Germany (Technikerkrankenkasse)." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Assignment to the treatment groups was random." |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described, however significant differences between completers and non‐completers were not reported |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment (1 month after end of treatment), 6 months | |
| Participants | End of treatment: n = 28 Start of treatment: n = 28 Sex: 14 F, 14 M Mean age = 10.8 years Source = community paediatrician referral, newspaper advertisement Diagnosis = migraine headache Mean years of pain = 4.3 | |
| Interventions | "Autogenic feedback training" | |
| Outcomes | Primary pain outcome: headache diary Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not reported Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "The children who attended the first session were matched on age, sex, and baseline headache index and then randomly assigned to either a treatment group or waiting‐list control group." |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts reported in study |
| Selective reporting (reporting bias) | Low risk | Data were reported fully |
| Study characteristics | ||
| Methods | RCT. 3 arms. Assessed at pretreatment, post‐treatment, 6 months | |
| Participants | End of treatment: n = 30 Start of treatment: n = 46 Sex: 17 F, 13 M Mean age = 12.0 years Source = not given Diagnosis = vascular or migraine headache Mean years of pain = not given | |
| Interventions | "Skin temperature biofeedback and autogenic relaxation" | |
| Outcomes | Primary pain outcome: headache diary Primary disability outcome: none Primary depression outcome: Childhood Depression Inventory Primary anxiety outcome: How‐I‐Feel questionnaire
| |
| Notes | COI: not reported Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Children were matched by age, sex, and baseline headache activity and then randomly assigned to one of three groups." |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Low risk | "Data on the dropouts were compared to those children participating in the treatment sessions. No differences were found in sex, age or headache history." |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |
| Study characteristics | ||
| Methods | RCT. 3 arms. Assessed at pretreatment, post‐treatment, 5 months | |
| Participants | End of treatment: n = 41 Start of treatment: n = 46 Sex: 40 F, 6 M Mean age = not given: range 16 to 18 years Source = not given Diagnosis = headache (migraine, tension, or both) Mean years of pain = mostly 1 to 5 years | |
| Interventions | "Therapist assisted relaxation" (n = 14) "Self‐help relaxation" (n = 16) "Self monitoring group" (n = 11) | |
| Outcomes | Primary pain outcome: headache sum Primary disability outcome: school absence Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not reported Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "In the randomisation procedure" |
| Allocation concealment (selection bias) | High risk | "In the randomisation procedure the following restrictions were applied: (a) class mates were assigned to the same treatment group in order to lessen the risk of treatment contamination, (b) subjects were evenly distributed across groups within separate schools." |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described, however significant differences between completers and non‐completers were not reported |
| Selective reporting (reporting bias) | High risk | Data were not fully reported |
| Study characteristics | ||
| Methods | RCT. 3 arms. Assessed at pretreatment, post‐treatment, 5 months | |
| Participants | End of treatment: n = 36; follow‐up: n = 34 Start of treatment: n = 36 Sex: 32 F, 2 M Mean age = 17 years Source = not given Diagnosis = headache Mean years of pain = mostly 1 to 5 years | |
| Interventions | "Self‐help relaxation" (n = 12) | |
| Outcomes | Primary pain outcome: headache sum Primary disability outcome: school absence Primary depression outcome: Depression Scale for Female Adolescents Primary anxiety outcome: Swedish translation of Children's Manifest Anxiety Scale
| |
| Notes | COI: not reported Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Finally, 36 students were randomly assigned to the three experimental conditions." |
| Allocation concealment (selection bias) | High risk | "The allocation of subjects was conducted with two restrictions on the procedure: (a) Classmates were assigned to the same treatment condition (to lessen the risk of treatment contamination), and (b) students with a high frequency of headaches were identified and evenly distributed across groups." |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | High risk | Attrition was not described |
| Selective reporting (reporting bias) | High risk | Data were not fully reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment | |
| Participants | End of treatment: n = 43 | |
| Interventions | “Self help relaxation” | |
| Outcomes | Primary pain outcome: headache activity Primary disability outcome: none given Primary depression outcome: Beck Depression Inventory Primary anxiety outcome: Modified Child Manifest Anxiety Scale
| |
| Notes | COI: none stated. Funding: none stated. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | “...the outlines of the study including the |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | “A graduate student in psychology administered |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described, however significant differences between completers and non‐completers were not reported |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment, 6 months | |
| Participants | End of treatment: n = 26 Start of treatment: n = 26 Sex: 25 F, 1 M Mean age = not given: range 10 to 15 years Source = school Diagnosis = headache Mean years of pain = 2.1 | |
| Interventions | "Relaxation treatment" | |
| Outcomes | Primary pain outcome: headache intensity Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not reported Funding: "This study was supported by grants from the First May Flower Annual Campaign and from the Glaxo and Allenburys AB, Sweden." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Thus, 26 pupils were randomly allocated into a relaxation training group or to a no‐treatment control group". |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Low risk | There were no dropouts reported in the study |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment, 3‐month follow‐up, 6‐month follow‐up | |
| Participants | End of treatment: n = 168; follow‐up 3 months: n = 143; follow‐up 6 months: n = 154 Start of treatment: n = 200 Sex: 145 F, 55 M Mean (SD) age = 11.21 years (2.55) Source = paediatric gastroenterology clinics at Seattle Children's Hospital and the Atlantic Health System in Morristown, New Jersey. Seattle participants were also recruited through local area clinics and community‐posted flyers Diagnosis = functional abdominal pain Mean years of pain = 3+ episodes of abdominal pain during a 3‐month period | |
| Interventions | "Cognitive‐behavioural treatment" | |
| Outcomes | Primary pain outcome: Faces Pain Scale‐Revised Primary disability outcome: Functional Disability Inventory Primary depression outcome: Children's Depression Inventory Primary anxiety outcome: Multidimensional Anxiety Scale for Children
| |
| Notes | COI: "William E. Whitehead is a member of the Board of Directors of the Rome Foundation. Nader Youssef is currently the Director of Clinical Research at AstraZeneca LP. At the time the study was conducted, however, he was not affiliated with this company and contributed to the project by his appointment at Goryeb Children’s Hospital." Funding: "This study was supported by grant number 5R01HD036069 from the National Institutes of Health — National Institute of Child Health and Human Development." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomisation was then performed by a different researcher using a computerised random‐number generator, stratifying by age." |
| Allocation concealment (selection bias) | Low risk | "Randomisation was then performed by a different researcher using a computerised random‐number generator, stratifying by age." |
| Blinding of outcome assessment (detection bias) | Low risk | "Nurse assessors were blind to the treatment assignment of the children." |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described; significant differences between completers and non‐completers are not reported |
| Selective reporting (reporting bias) | Unclear risk | Data were fully reported when requested |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment, 3 months, 6 months, and 12 months | |
| Participants | End of treatment: n = 158; follow‐up 3 months: n = 137; follow‐up 6 months: n = 144, follow‐up 12 months: n = 133 Start of treatment: n = 185 Sex: 87 F, 98 M Mean age = 13.5 years (SD = 2.7) Source = paediatric GI clinics Diagnosis = Crohn's disease or ulcerative colitis Mean years of pain = not reported | |
| Interventions | "Social learning cognitive‐behavioral therapy" "Education support" | |
| Outcomes | Primary pain outcome: none Primary disability outcome: Functional Disability Inventory Primary depression outcome: Children's Depression Inventory Primary anxiety outcome: Multidimensional Anxiety Scale for Children
| |
| Notes | COI: "The authors have no conflict of interest to disclose." Funding: "Supported by a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (award number R01HD050345 to R. L. Levy)." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomization was then performed by a different researcher using a computerized random‐number generator, stratifying by age (7–11 or 12–18 years old) and then by physician‐reported disease severity (quiescent, mild, or moderate/severe based on either the Pediatric Ulcerative Colitis Activity Index (PUCAI) for patients with UC or the Pediatric Crohn’s Disease Activity Index (PCDAI) for Crohn’s patients) completed during enrolment." Comment: probably done |
| Allocation concealment (selection bias) | Unclear risk | No description Comment: probably not done |
| Blinding of outcome assessment (detection bias) | Low risk | "At all assessment points, parents completed questionnaires online or by mail (whichever modality they preferred). Children completed assessments through a scheduled telephone call with a highly trained research nurse who was blinded to the participant’s treatment assignment." Comment: probably done |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described; significant differences between completers and non‐completers were not reported |
| Selective reporting (reporting bias) | Low risk | Data were fully reported. |
| Study characteristics | ||
| Methods | RCT. 3 arms (only 2 arms included here, see Interventions below). Assessed at pretreatment, 1 week, 3 months, and 6 months after treatment. | |
| Participants | End of treatment: n = 166 children; 170 parents. 3 month follow‐up: n = 160 children; 164 parents. 6 months follow‐up: n = 159 children; 164 parents. Start of treatment: n = 216 Child Sex: 140 F, 76 M; Parent Sex: 205 F, 11 M Child mean age = 9.4 years (SD = 1.7); parent mean age = 39.8 years (7.7) Source = paediatric GI clinics Diagnosis = functional abdominal pain Mean years of pain = not reported | |
| Interventions | "Social learning cognitive‐behavioral therapy (face‐to‐face)" "Social learning cognitive‐behavioral therapy‐Remote (delivered via the telephone)" ‐ this condition was excluded from this review. See Fisher 2015 for remotely‐delivered psychological interventions. "Education support" | |
| Outcomes | Primary pain outcome: Abdominal Pain Index‐ Severity Primary disability outcome: Functional Disability Inventory (parent report) Primary depression outcome: None Primary anxiety outcome: Pain Response Inventory ‐ Catastrophizing subscale
| |
| Notes | COI: "The authors have no conflicts of interest relevant to this article to disclose." Funding: "This study was supported by award R01HD36069‐0981 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (R.L.L.)." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomization using a computer‐generated randomization sequence occurred after baseline assessments, stratified by child gender and baseline parent‐reported child pain severity scores on the Abdominal Pain Index (API) (scores at or above 1.75 [the median value from our previous study] vs below)" Comment: probably done |
| Allocation concealment (selection bias) | Unclear risk | "After enrolment and completion of baseline assessments, the study coordinator queried the randomization database for treatment assignment and then scheduled sessions with the Comment: unclear allocation concealment |
| Blinding of outcome assessment (detection bias) | Low risk | "Parents completed questionnaires online or by mail (90.5% online). Children completed assessments through a telephone call with a trained interviewer blinded to study hypotheses and treatment assignment." Comment: probably done |
| Incomplete outcome data (attrition bias) | Unclear risk | Data attrition fully reported. Differences between completers and non‐completers of the study |
| Selective reporting (reporting bias) | Low risk | All data was reported |
| Study characteristics | ||
| Methods | RCT. 3 arms. Assessed at pretreatment, post‐treatment, 3 months, 12 months | |
| Participants | End of treatment: n = 99 Start of treatment: n = 136 Sex: 69 F, 30 M Mean age = 13.1 years (range 11 to 18) Source = hospital Diagnosis = headache Mean years of pain = not given: minimum 3 months | |
| Interventions | "Relaxation training" | |
| Outcomes | Primary pain outcome: headache index Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not reported Funding: "Research supported by the Ontario Ministry of Health, Ontario Ministry of Community and Social Services and the Children's Hospital of Eastern Ontario. Dr. McGrath is supported by a Career Scientist Award of the Ontario Ministry of Health." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomly assigned to one of three groups" |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Low risk | Attrition was described, however significant differences between completers and non‐completers were not reported |
| Selective reporting (reporting bias) | Low risk | Data were completely reported |
| Study characteristics | ||
| Methods | RCT. 3 arms. Assessed at pretreatment, post‐treatment, 3 months, and 1‐year follow‐up | |
| Participants | End of treatment: n = 74 Start of treatment: n = 87 Sex: 63 F, 24 M Mean age = not given: range 11 to 18 years Source = paediatricians and family physicians Diagnosis = migraine Mean years of pain not given: minimum 3 months | |
| Interventions | "Therapist administered cognitive behavioural/stress coping/relaxation training" "Self‐administered cognitive behavioural/stress coping/relaxation training" "Information and support" | |
| Outcomes | Primary pain outcome: headache diary Primary disability outcome: none Primary depression outcome: Poznanski Depression Scale Primary anxiety outcome: none
| |
| Notes | COI: not reported Funding: "This research was funded by the National Health and Welfare Research and DeveIopment Program of Canada. Dr. McGrath was supported by a Career Scientist Award of the Ontario Ministry of Health." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomised to 1 of the 8‐week treatments" |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described, however significant differences between completers and non‐completers were not reported |
| Selective reporting (reporting bias) | High risk | Data were incompletely reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment and 1‐year follow‐up | |
| Participants | End of treatment: n = 39, 1‐year follow‐up: n = 21 Start of treatment: n = 39 Sex: 29 F, 10 M Mean age = 15.2 years (SD 3.3) Source = newspaper article Diagnosis = headache (migraine, tension‐type, mixed) Mean years of pain = 5.6 | |
| Interventions | "Behavioural treatment package" | |
| Outcomes | Primary pain outcome: headache index Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not reported. Funding: "This study was supported by Iht: Dutch Fund for Menial Hcalqh (NFGV)." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "The participants were randomly assigned to one of two groups" |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | High risk | Attrition was not described |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment and 3 month follow‐up | |
| Participants | End of treatment: n = 60, 3 month follow‐up: n = 59 Start of treatment: n = 61 Child sex: 49 F, 11 M Parent sex: 60 F, 1 M Child mean (SD) age = 14.07 years (1.80) Source = pain clinic Diagnosis = mixed chronic pain conditions Mean years of pain = unknown | |
| Interventions | "Problem‐solving skills training" "Treatment‐as‐usual" | |
| Outcomes | Primary pain outcome: Child pain intensity Primary disability outcome: Physical disability (BAPQ) Primary depression outcome: Depression (BAPQ) Primary anxiety outcome: General anxiety (BAPQ)
| |
| Notes | COI: "The authors have no conflicts of interest to declare." Funding: "Research reported in this publication was supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number R21HD065180 (PI: T. M. P.)." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "A fixed allocation randomization scheme was used. The order of randomization to the 2 treatment conditions was generated separately for each site with an online program (randomizer.org). A blocked method design was used, with blocks of 4 for each identification number" Comment: probably done |
| Allocation concealment (selection bias) | Low risk | "Only the research coordinator had the password to the randomization table. Group assignment was concealed by formatting the document to block out group assignment until the time of randomization." Comment: probably done |
| Blinding of outcome assessment (detection bias) | Low risk | "All study assessments were self‐report measures completed in participants’ homes through mailings; children and parents were instructed to complete the measures independently." Comment: probably done |
| Incomplete outcome data (attrition bias) | Low risk | Attrition was fully reported and there were no differences between completers and non‐completers |
| Selective reporting (reporting bias) | Low risk | All data were fully reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment | |
| Participants | End of treatment: n = 119 Start of treatment: n = 119 Sex: 65 F, 54 M Mean age = 13.7 years (SD 1.4) Source = school Diagnosis = headache (at least weekly) Mean years of pain = none given | |
| Interventions | "Progressive relaxation training" | |
| Outcomes | Primary pain outcome: headache intensity Primary disability outcome: school problems Primary depression outcome: none Primary anxiety outcome: Fear of Failure
| |
| Notes | COI: not reported Funding: not reported | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "The 19 classes of the participating teachers were allocated at random to a Progressive Relaxation Training or a Placebo Training group." |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Low risk | No dropouts were reported |
| Selective reporting (reporting bias) | High risk | Data were incompletely reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed pretreatment, post‐treatment, and 12 months | |
| Participants | End of treatment: n = 124 Start of treatment: n = 135 Sex: 107 F, 28 M Mean age = 14.4 years (SD 2.0) Source = clinic Diagnosis = migraine Mean years of pain = none given | |
| Interventions | "Cognitive behavioral therapy plus amitriptyline" "Headache education plus amitriptyline" | |
| Outcomes | Primary pain outcome: headache frequency Primary disability outcome: Ped‐MIDAS Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: "The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported." Funding: "Funding was provided by grant R01NS05036 from the National Institute of Neurological Disorders and Stroke (Dr Powers), grant 8 UL1 TR000077 from the National Center for Research Resources and the National Center for Advancing Translational Sciences, and grant T32DK063929 from the National Institute of Diabetes and Digestive and Kidney Diseases for some of the postdoctoral fellows who contributed to the trial (Dr Powers, program director). Amitriptyline, which was provided without cost to participants, was purchased using National Institutes of Health grant funds and managed by the investigational pharmacy at Cincinnati Children’s Hospital Medical Center. If prevention drug was clinically prescribed during the 12‐month follow‐up period, families had financial responsibility for the medications as with typical clinical practice." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Block randomization (with varying block sizes of 4‐10) was used, and participants were stratified by age. Randomization was computer generated and supplied via secure e‐mail to the study therapist." |
| Allocation concealment (selection bias) | Low risk | "Randomization was computer generated and supplied via secure e‐mail to the study therapist." |
| Blinding of outcome assessment (detection bias) | Low risk | "Outcome assessments were conducted by blinded study personnel." |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described, however significant differences between completers and non‐completers were not described |
| Selective reporting (reporting bias) | Unclear risk | Data fully reported on request |
| Study characteristics | ||
| Methods | RCT. 3 arms. Assessed at pretreatment, post‐treatment | |
| Participants | End of treatment: n = 43 Start of treatment: n = 51 Sex: 34 F, 17 M Mean age = 12.9 years Source = referred by physicians to children's hospital Diagnosis = migraine Mean years of pain = not given: mostly over 2 years | |
| Interventions | "Relaxation training" | |
| Outcomes | Primary pain outcome: headache diary Primary disability outcome: none Primary depression outcome: Child Depression Rating Scale Primary anxiety outcome: State Trait Anxiety Inventory
| |
| Notes | COI: not reported Funding: "This research was supported by grants from the Ontario Ministry of Health and the Ontario Ministry of Community and Social Services." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "... and randomly assigned to treatment" |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text Comment: probably not done |
| Incomplete outcome data (attrition bias) | Low risk | "Over the course of treatment there were 8 drop‐outs. A chi‐square analysis comparing attrition rates across interventions was not significant." |
| Selective reporting (reporting bias) | High risk | Data were incompletely reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment (3 months after start), 6 to 12 months | |
| Participants | End of treatment: n = 69 Start of treatment: n = 86 Sex: 39 F, 30 M Mean age = 11.4 years (SD 2.4) Source = paediatric gastroenterology outpatient clinic of children's hospital Diagnosis = recurrent abdominal pain Mean years of pain = not stated | |
| Interventions | "Short term cognitive behavioural family treatment plus standard medical care" "Standard medical care" | |
| Outcomes | Primary pain outcome: Abdominal Pain Index Primary disability outcome: Functional Disability Inventory Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not reported. Funding: "This study was supported in part by a grant through the Nemours Research Programs, awarded to the first author." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The remaining sample of 86 were randomly assigned using a coin‐flip method." |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described, however significant differences between completers and non‐completers were not described |
| Selective reporting (reporting bias) | High risk | Data were incompletely reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment, 6 months, 1 year | |
| Participants | End of treatment: n = 44 Start of treatment: n = 44 Sex: 28 F, 16 M Mean age = 9.2 years (SD 1.9) Source = not given Diagnosis = recurrent abdominal pain Mean years of pain = 3.7 | |
| Interventions | "Cognitive behaviour therapy" | |
| Outcomes | Primary pain outcome: pain diary Primary disability outcome: interference with child activity Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not reported Funding: "This study was supported by Grant 53091 from the National Health and Medical Research Council of Australia to Matthew R. Sanders, Ross W. Shepherd, and Geoggery Cleghorn." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "The study used a randomised group comparison design with two treatment conditions." |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | High risk | Attrition was not described and significant differences between completers and non‐completers were not reported |
| Selective reporting (reporting bias) | High risk | Data were incompletely reported |
| Study characteristics | ||
| Methods | RCT. 3 arms. Assessed at pretreatment, post‐treatment (4 weeks after end of intervention), 8 months follow‐up | |
| Participants | End of treatment: n = 43 Start of treatment: n = 43 Sex: 17 F, 26 M Mean age = 11.3 years (SD 2.1) Source = outpatient clinic of paediatric hospital and advertising in press Diagnosis = migraine Mean years of pain = 4.6 | |
| Interventions | "Cephalic vasomotor training + stress management" "Relaxation training + stress management" "Beta‐blocker (metoprolol)" | |
| Outcomes | Primary pain outcome: headache index Primary disability outcome: none Primary depression outcome: mood faces scale Primary anxiety outcome: none
| |
| Notes | COI: not reported Funding: "This study was supported by the Bundesminister fuÈ r Forschung und Technologie (BMFT; Federal Minister for Research and Technology, Germany)." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Children were allocated randomly to one of three treatment groups" |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described, however significant differences between completers and non‐completers were not described |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |
| Study characteristics | ||
| Methods | RCT. 3 arms. Assessed at pretreatment, post‐treatment, 3 months, 6 months, 12 months | |
| Participants | End of treatment: n = 34 Start of treatment: n = 36 Sex: 24 F, 12 M Mean age 12.8 years (SD 2.4) Source = children's hospital Diagnosis = migraine (all), tension‐type headache (minority) Mean years of pain = 2.4 (SD 2.1) | |
| Interventions | "Handwarming biofeedback and stress management" "Handcooling attention control" "Waitlist control" | |
| Outcomes | Primary pain outcome: headache index Primary disability outcome: none Primary depression outcome: Child Depression Inventory Primary anxiety outcome: State Trait Anxiety Inventory for Children
| |
| Notes | COI: not reported Funding: "This research was supported by grants from the University of Pittsburgh Anethesiology and Critical Care Foundatation, the Raymond and Elizabeth Bloch Educational and Charitable Foundation, and the NIH/NICHD (HD38647)." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "At the assessment visit children were randomised into three groups using a randomisation table" |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Low risk | Attrition was described; there were no significant differences between completers and non‐completers |
| Selective reporting (reporting bias) | High risk | Data were incompletely reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed pretreatment, post‐treatment, 6 months, and 12 months follow‐up | |
| Participants | End of treatment: n = 92; n = 88 at 12 months follow‐up Start of treatment: n = 104 Sex: 24 F, 12 M Mean age 11.9 years (SD 2.77) Source = children's hospital Diagnosis = abdominal pain Mean months of pain = 34.01 (SD 37.54) | |
| Interventions | "Cognitive behavior therapy" "Intensive medical care" | |
| Outcomes | Primary pain outcome: Abdominal Pain Index (child report) Primary disability outcome: Functional Disability Inventory (child report) Primary depression outcome: Revised Child Anxiety and Depression Scale ‐ Short Version (child report) Primary anxiety outcome: Revised Child Anxiety and Depression Scale ‐ Short Version (child report)
| |
| Notes | COI: "The authors have indicated they have no potential conflicts of interest to disclose." Funding: "The current study was funded by the Dutch Digestive Foundation, grant SWO 05‐09." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "The first author randomized the children using a computerized randomization program" |
| Allocation concealment (selection bias) | Unclear risk | No description found in text |
| Blinding of outcome assessment (detection bias) | Unclear risk | "Diary data were entered in SPSS by students who were blinded to treatment." |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described, however significant differences between completers and non‐completers were not described |
| Selective reporting (reporting bias) | Unclear risk | Data fully reported when requested |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment, 6 months | |
| Participants | End of treatment: n = 29; follow‐up: n = 24 | |
| Interventions | “Guided imagery treatment” | |
| Outcomes | Primary pain outcome: Abdominal Pain Index Primary disability outcome: Functional Disability Inventory Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: the authors indicated they had no financial relationships relevant to this article to disclose Funding: this work was supported by National Institutes of Health grants R24 DK067674 and RR00046 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | “Thirty‐four children were assigned randomly |
| Allocation concealment (selection bias) | Low risk | “Children picked a closed envelope that determined whether they would receive standard medical care with or without guided imagery treatment.” |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described, however significant |
| Selective reporting (reporting bias) | Unclear risk | Data provided on request. |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment, 6 months, 1 year | |
| Participants | End of treatment: n = 51 Start of treatment: n = 52 Sex: 39 F, 13 M Mean age = 13.3 years (SD 2.7) Source = paediatric gastroenterology department in hospital Diagnosis = functional abdominal pain (n = 31) and irritable bowel syndrome (IBS) (n = 22) Mean years of pain = 3.4 | |
| Interventions | "Gut‐directed hypnotherapy" "Standard medical care plus supportive therapy" | |
| Outcomes | Primary pain outcome: weekly pain intensity Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not reported. Funding: "There was no external funding source." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Patients were randomly allocated using a computerised random‐number generator for concealment to either HT or standard medical care." |
| Allocation concealment (selection bias) | Low risk | "Patients were randomly allocated using a computerised random‐number generator for concealment to either HT or standard medical care." |
| Blinding of outcome assessment (detection bias) | Low risk | "Pain diaries were analysed by S. W. (medical student), who was blinded to the treatment arm." |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described, however significant differences between completers and non‐completers were not reported |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |
| Study characteristics | ||
| Methods | RCT. 3 arms. Assessed at pretreatment, post‐treatment, and 6 months | |
| Participants | End of treatment: n = 110 Start of treatment: n = 122 (BI + RT = 41; BI + OA = 42; BI = 39) Sex: 93 F, 29 M Mean age = 15.3 years (SD 2.0) Source = TMD clinic in Linköping, Sweden Diagnosis = temporomandibular disorders Mean years of pain = unknown | |
| Interventions | "Brief Information + Relaxation training (BI + RT)"* "Brief Information + Occlusal appliance (BI + OA)" "Brief Information"* *For the purposes of this review, we excluded only BI + RT (treatment) and BI (control) | |
| Outcomes | Primary pain outcome: pain intensity Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: not reported Funding: "The study was supported by the Public Dental Service of Östergötland (Östergötland's Country Council), Sweden." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "The patients were randomly assigned to one of the following 3 treatment groups...." Comment: randomisation procedure unclear |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of outcome assessment (detection bias) | Low risk | "At each evaluation, all subjects filled out a self‐administered questionnaire and were clinically examined by a 'blinded' calibrated clinician." Comment: probably done |
| Incomplete outcome data (attrition bias) | Low risk | Attrition reported, and there were no differences between completers and non‐completers |
| Selective reporting (reporting bias) | Low risk | All measures were reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment and three months. Non‐responders were then assigned to the other condition and assessed at 6 months. We extracted data only from the three‐month time point | |
| Participants | End of treatment: n = 57 Start of treatment: n = 64 Sex: 61 F, 3 M Mean age = 16.4 years (SD 1.87) Source = two specialist temporomandibular clinics in Sweden Diagnosis = temporomandibular pain at least once a week for more than three months Mean years of pain = 23.9 months (SD 19.05) | |
| Interventions | "Occlusal appliance therapy" "Relaxation treatment" | |
| Outcomes | Primary pain outcome: pain intensity Primary disability outcome: none Primary depression outcome: none Primary anxiety outcome: none
| |
| Notes | COI: "The authors report no conflicts of interest related to this study." Funding: "This study was supported by the Swedish Dental Society; the Public Dental Service of (Östergötland County Council), Sweden; and the Public Dental Service of Kalmar (Kalmar County Council), Sweden. The authors report no conflicts of interest related to this study." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Using a random number table, a secretary not otherwise involved in the study generated the allocation sequence to assign patients to a treatment, either occlusal appliance therapy or relaxation treatment." Comment: probably done |
| Allocation concealment (selection bias) | Low risk | "Using a random number table, a secretary not otherwise involved in the study generated the allocation sequence to assign patients to a treatment, either occlusal appliance therapy or relaxation treatment. The secretary put these assignments in sealed opaque envelopes." Comment: probably done |
| Blinding of outcome assessment (detection bias) | Unclear risk | No description found in text |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described, however significant differences between completers and non‐completers were not reported |
| Selective reporting (reporting bias) | Low risk | Data fully reported |
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed at pretreatment, post‐treatment, 3.5 months, 6.8 months | |
| Participants | End of treatment: n = 29; follow‐up 3.5 months: n = 24; follow‐up 6.8 months: n = 24 Start of treatment: n = 32 Sex: 25 F, 7 M Mean age = 14.8 years (SD 2.4) Source = Astrid Lindgren Children's Hospital, Karolinska University Hospital Diagnosis = mixed pain (headache, back/neck, widespread musculoskeletal, complex regional pain syndrome, visceral, lower extremities, postherpetic type cheek pain) Mean years of pain = 2.7 | |
| Interventions | "Exposure and acceptance" "Multidisciplinary treatment and amitriptyline" | |
| Outcomes | Primary pain outcome: pain intensity Primary disability outcome: Functional Disability Inventory Primary depression outcome: Center for Epidemiological Studies Depression Scale for Children Primary anxiety outcome: Pain Coping Scale (catastrophising subscale)
| |
| Notes | COI: "There are no financial or other relationships that might lead to a conflict of interest." Funding: "This study was in part financed by the Swedish Research Council and by fundings from the Karolinska Institute." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "A total of 32 participants were included in the study and randomised to one of the two treatment conditions. A simple randomisation technique was used." |
| Allocation concealment (selection bias) | Low risk | "A sealed envelope (prepared by a secretary blind to the objective of the study) containing a code for 'exposure and acceptance' or 'MDT' was opened, assigning the participant to one of the treatment conditions." |
| Blinding of outcome assessment (detection bias) | Low risk | "All assessments were conducted by a nurse who was not involved in delivering the treatment protocol." |
| Incomplete outcome data (attrition bias) | Unclear risk | Attrition was described, however significant differences between completers and non‐completers were not reported |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |
AP: abdominal pain
BAPQ:
BFB‐REL:
BI:
CBCL:
CBT: cognitive behavioural therapy
CDI:
CDS:
CHS:
CMAS:
COI:
COPE‐HEP:
DIKJ:
F: female
FDI‐C: Functional Disability Inventory ‐ Children
HCM:
HT: hypnotherapy
IBD: inflammatory bowel disease (IBD)
IMPACT:
JPFM: juvenile primary fibromyalgia
KIDSCREEN:
KINDL‐R
M: male
MDT:
MEMS:
NRS: numeric rating scale
OA:
PCQ:
Ped‐MIDAS: Pediatric Migraine Disability Assessment
PEDSQL: Paediatric Scale Quality of Life Inventory
POR:
PSSI:
RCT: randomised controlled trial
RT:
SC:
SCD: sickle cell disease
SD: standard deviation
SS:
STAI:
STAIC:
TAT:
TCM:
TMD:
TT:
VAS: visual analogue scale
Characteristics of excluded studies [ordered by study ID]
Ir a:
| Study | Reason for exclusion |
| Intervention delivered remotely | |
| Inadequate sample size (n < 10 in 1 arm of study design) | |
| Non‐inferiority trial | |
| Intervention delivered remotely | |
| Inadequate sample size (n < 10 in 1 arm of study design) | |
| Insufficient psychological treatment | |
| Insufficient psychological treatment | |
| Inadequate sample size (n < 10 in 1 arm of study design) | |
| Inadequate sample size (n < 10 in 1 arm of study design) | |
| Insufficient psychological treatment | |
| Intervention delivered remotely | |
| Intervention delivered remotely | |
| Non‐inferiority trial | |
| Inadequate sample size (n < 10 in 1 arm of study design) | |
| Intervention delivered remotely | |
| Inadequate sample size (n < 10 in 1 arm of study design) | |
| Intervention delivered remotely | |
| Follow‐up period more than 1 year | |
| Inadequate sample size (n < 10 in 1 arm of study design) | |
| Inadequate sample size (n < 10 in 1 arm of study design) |
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Pain Show forest plot | 15 | 644 | Risk Ratio (M‐H, Random, 95% CI) | 2.35 [1.67, 3.30] |
| Analysis 1.1  Comparison 1: Treatment versus control (headache) post‐treatment, Outcome 1: Pain | ||||
| 1.1.1 N < 20 | 13 | 437 | Risk Ratio (M‐H, Random, 95% CI) | 2.86 [1.73, 4.72] |
| 1.1.2 N > 20 | 2 | 207 | Risk Ratio (M‐H, Random, 95% CI) | 1.88 [1.36, 2.58] |
| 1.2 Disability Show forest plot | 6 | 446 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.26 [‐0.56, 0.03] |
| Analysis 1.2  Comparison 1: Treatment versus control (headache) post‐treatment, Outcome 2: Disability | ||||
| 1.2.1 N < 20 | 2 | 61 | Std. Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.47, 0.54] |
| 1.2.2 N > 20 | 4 | 385 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.35 [‐0.69, ‐0.00] |
| 1.3 Depression Show forest plot | 6 | 400 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.08 [‐0.28, 0.11] |
| Analysis 1.3  Comparison 1: Treatment versus control (headache) post‐treatment, Outcome 3: Depression | ||||
| 1.3.1 N < 20 | 3 | 103 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.16 [‐0.68, 0.35] |
| 1.3.2 N > 20 | 3 | 297 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.06 [‐0.29, 0.17] |
| 1.4 Anxiety Show forest plot | 7 | 439 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.11 [‐0.39, 0.17] |
| Analysis 1.4  Comparison 1: Treatment versus control (headache) post‐treatment, Outcome 4: Anxiety | ||||
| 1.4.1 N < 20 | 4 | 136 | Std. Mean Difference (IV, Random, 95% CI) | 0.01 [‐0.54, 0.57] |
| 1.4.2 N > 20 | 3 | 303 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.19 [‐0.49, 0.11] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Pain Show forest plot | 5 | 223 | Risk Ratio (M‐H, Random, 95% CI) | 2.73 [0.98, 7.63] |
| Analysis 2.1  Comparison 2: Treatment versus control (headache) follow‐up, Outcome 1: Pain | ||||
| 2.1.1 N < 20 | 4 | 99 | Risk Ratio (M‐H, Random, 95% CI) | 3.49 [1.31, 9.26] |
| 2.1.2 N > 20 | 1 | 124 | Risk Ratio (M‐H, Random, 95% CI) | 1.25 [1.03, 1.52] |
| 2.2 Disability Show forest plot | 3 | 209 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.37 [‐0.65, ‐0.10] |
| Analysis 2.2  Comparison 2: Treatment versus control (headache) follow‐up, Outcome 2: Disability | ||||
| 2.2.1 N < 20 | 1 | 24 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.45 [‐1.27, 0.36] |
| 2.2.2 N > 20 | 2 | 185 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.36 [‐0.65, ‐0.07] |
| 2.3 Depression Show forest plot | 3 | 228 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.05 [‐0.62, 0.52] |
| Analysis 2.3  Comparison 2: Treatment versus control (headache) follow‐up, Outcome 3: Depression | ||||
| 2.3.1 N < 20 | 1 | 24 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.54 [‐1.36, 0.28] |
| 2.3.2 N > 20 | 2 | 204 | Std. Mean Difference (IV, Random, 95% CI) | 0.11 [‐0.61, 0.83] |
| 2.4 Anxiety Show forest plot | 4 | 271 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.12 [‐0.46, 0.21] |
| Analysis 2.4  Comparison 2: Treatment versus control (headache) follow‐up, Outcome 4: Anxiety | ||||
| 2.4.1 N < 20 | 2 | 67 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.28 [‐1.00, 0.45] |
| 2.4.2 N > 20 | 2 | 204 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.04 [‐0.48, 0.41] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Pain Show forest plot | 16 | 1210 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.43 [‐0.67, ‐0.19] |
| Analysis 3.1  Comparison 3: Treatment versus control (mixed pain) post‐treatment, Outcome 1: Pain | ||||
| 3.1.1 N < 20 | 7 | 250 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.83 [‐1.19, ‐0.46] |
| 3.1.2 N > 20 | 9 | 960 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.20 [‐0.45, 0.05] |
| 3.2 Disability Show forest plot | 14 | 1226 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.34 [‐0.54, ‐0.15] |
| Analysis 3.2  Comparison 3: Treatment versus control (mixed pain) post‐treatment, Outcome 2: Disability | ||||
| 3.2.1 N < 20 | 6 | 213 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.72 [‐1.17, ‐0.26] |
| 3.2.2 N > 20 | 8 | 1013 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.20 [‐0.37, ‐0.04] |
| 3.3 Depression Show forest plot | 8 | 757 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.05 [‐0.23, 0.12] |
| Analysis 3.3  Comparison 3: Treatment versus control (mixed pain) post‐treatment, Outcome 3: Depression | ||||
| 3.3.1 N < 20 | 2 | 59 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.27 [‐0.95, 0.41] |
| 3.3.2 N > 20 | 6 | 698 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.03 [‐0.21, 0.15] |
| 3.4 Anxiety Show forest plot | 8 | 957 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.16 [‐0.29, ‐0.03] |
| Analysis 3.4  Comparison 3: Treatment versus control (mixed pain) post‐treatment, Outcome 4: Anxiety | ||||
| 3.4.1 N < 20 | 1 | 32 | Std. Mean Difference (IV, Random, 95% CI) | 0.12 [‐0.57, 0.82] |
| 3.4.2 N > 20 | 7 | 925 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.17 [‐0.30, ‐0.04] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 4.1 Pain Show forest plot | 9 | 833 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.08 [‐0.30, 0.13] |
| Analysis 4.1  Comparison 4: Treatment versus control (mixed pain) follow‐up, Outcome 1: Pain | ||||
| 4.1.1 N < 20 | 2 | 53 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.94 [‐1.75, ‐0.13] |
| 4.1.2 N > 20 | 7 | 780 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.00 [‐0.15, 0.14] |
| 4.2 Disability Show forest plot | 9 | 935 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.27 [‐0.49, ‐0.06] |
| Analysis 4.2  Comparison 4: Treatment versus control (mixed pain) follow‐up, Outcome 2: Disability | ||||
| 4.2.1 N < 20 | 2 | 53 | Std. Mean Difference (IV, Random, 95% CI) | ‐1.17 [‐2.60, 0.26] |
| 4.2.2 N > 20 | 7 | 882 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.20 [‐0.34, ‐0.07] |
| 4.3 Depression Show forest plot | 7 | 667 | Std. Mean Difference (IV, Random, 95% CI) | 0.09 [‐0.10, 0.28] |
| Analysis 4.3  Comparison 4: Treatment versus control (mixed pain) follow‐up, Outcome 3: Depression | ||||
| 4.3.1 N < 20 | 1 | 24 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.53 [‐1.35, 0.29] |
| 4.3.2 N > 20 | 6 | 643 | Std. Mean Difference (IV, Random, 95% CI) | 0.12 [‐0.06, 0.30] |
| 4.4 Anxiety Show forest plot | 8 | 875 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.01 [‐0.20, 0.18] |
| Analysis 4.4  Comparison 4: Treatment versus control (mixed pain) follow‐up, Outcome 4: Anxiety | ||||
| 4.4.1 N < 20 | 1 | 32 | Std. Mean Difference (IV, Random, 95% CI) | 0.09 [‐0.60, 0.79] |
| 4.4.2 N > 20 | 7 | 843 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.01 [‐0.22, 0.19] |
Study flow diagram.
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Forest plot of comparison: 1 Treatment versus control (headache) post‐treatment, outcome: 1.1 Pain.
Forest plot of comparison: 3 Treatment versus control (mixed chronic pain conditions) post‐treatment, outcome: 3.1 Pain.
Comparison 1: Treatment versus control (headache) post‐treatment, Outcome 1: Pain
Comparison 1: Treatment versus control (headache) post‐treatment, Outcome 2: Disability
Comparison 1: Treatment versus control (headache) post‐treatment, Outcome 3: Depression
Comparison 1: Treatment versus control (headache) post‐treatment, Outcome 4: Anxiety
Comparison 2: Treatment versus control (headache) follow‐up, Outcome 1: Pain
Comparison 2: Treatment versus control (headache) follow‐up, Outcome 2: Disability
Comparison 2: Treatment versus control (headache) follow‐up, Outcome 3: Depression
Comparison 2: Treatment versus control (headache) follow‐up, Outcome 4: Anxiety
Comparison 3: Treatment versus control (mixed pain) post‐treatment, Outcome 1: Pain
Comparison 3: Treatment versus control (mixed pain) post‐treatment, Outcome 2: Disability
Comparison 3: Treatment versus control (mixed pain) post‐treatment, Outcome 3: Depression
Comparison 3: Treatment versus control (mixed pain) post‐treatment, Outcome 4: Anxiety
Comparison 4: Treatment versus control (mixed pain) follow‐up, Outcome 1: Pain
Comparison 4: Treatment versus control (mixed pain) follow‐up, Outcome 2: Disability
Comparison 4: Treatment versus control (mixed pain) follow‐up, Outcome 3: Depression
Comparison 4: Treatment versus control (mixed pain) follow‐up, Outcome 4: Anxiety
| Psychological therapies compared with any control for children and adolescents with frequent headaches | ||||||
| Patient or population: Children and adolescents with chronic pain Settings: Community and hospitals Intervention: Psychological therapies (cognitive behavioural therapy or behavioural therapy) Comparison: Any control (active, treatment‐as‐usual, wait‐list) | ||||||
| Outcomes | Probable outcome with control | Probable outcome with intervention | NNTB and/or relative effect | No of Participants | Quality of the evidence | Comments |
|---|---|---|---|---|---|---|
| Pain: 50% reduction in headache frequency Post‐treatment Lower scores = fewer headaches | 10 per 1000 | 24 per 1000 | NNTB = 2.86; RR 2.35 (1.67 to 3.30) | 644 participants | ⊕⊝⊝⊝ | |
| Pain: 50% reduction in headache frequency Follow‐up (up to 12 months) Lower scores = fewer headaches | 10 per 1000 | 27 per 1000 | NNTB = 3.16; RR 2.73 (0.98 to 7.63) | 223 participants (5 studies) | ⊕⊝⊝⊝ | |
| Disability Post‐treatment Lower scores = lower reported disability | The mean disability in the intervention groups was 0.26 lower (95% CI ‐0.56 to 0.03) | 446 participants (6 studies) | ⊕⊝⊝⊝ | |||
| Disability Follow‐up Lower scores = lower reported disability | The mean disability in the intervention groups was 0.37 lower (95% CI ‐0.65 to ‐0.10) | 209 participants (3 studies) | ⊕⊝⊝⊝ | |||
| Anxiety Post‐treatment Lower scores = lower reported anxiety | The mean anxiety in the intervention groups was 0.11 lower (95% CI ‐0.39 to 0.17) | 439 participants (7 studies) | ⊕⊝⊝⊝ | |||
| Anxiety Follow‐up Lower scores = lower reported anxiety | The mean anxiety in the intervention groups was 0.12 lower (95% CI ‐0.46 to 0.21) | 271 participants (4 studies) | ⊕⊝⊝⊝ | |||
| Depression Post‐treatment Lower scores = lower reported depression | The mean depression in the intervention groups was 0.08 lower (95% CI ‐0.28 to 0.11) | 400 participants (6 studies) | ⊕⊝⊝⊝ | |||
| CI: Confidence interval; RR: Risk Ratio; NNTB; Number needed to treat to benefit. | ||||||
| GRADE Working Group grades of evidence | ||||||
| a50 to 75% risk of bias ratings were unclear/high. b> 75% of risk of bias ratings were unclear or high. cConfidence intervals were wide. dHeterogeneity (I2) was 46 to 65%. eHeterogeneity (I2) was 66 to 100%. f75 to 100% of studies eligible to be included in the analysis were not included in the analysis. gSmall number of participants contributing to the outcome. hAsymmetrical funnel plots suggesting publication bias. iThere was mostly unclear/high risk of bias in the selective reporting category. | ||||||
| Psychological therapies compared with any control for children and adolescents with chronic pain conditions (mixed) | |||||
| Patient or population: Children and adolescents with chronic pain Settings: Community and hospitals Intervention: Psychological therapies (cognitive behavioural therapy or behavioural therapy) Comparison: Any control (active, treatment‐as‐usual, wait‐list) | |||||
| Outcomes | Probable outcome with control | Probable outcome with intervention | No of Participants | Quality of the evidence | Comments |
|---|---|---|---|---|---|
| Pain Post‐treatment Lower scores = lower reported pain intensity | The mean pain intensity in the intervention group was 0.43 lower (95% CI ‐0.67 to ‐0.19) | 1210 participants (16 studies) | ⊕⊝⊝⊝ | ||
| Pain Follow‐up Lower scores = lower reported pain intensity | The mean pain intensity in the intervention group was 0.08 lower (95% CI ‐0.30 to 0.13) | 763 participants (9 studies) | ⊕⊝⊝⊝ | ||
| Disability Post‐treatment Lower scores = lower reported disability | The mean disability in the intervention group was 0.34 lower (95% CI ‐0.54 to ‐0.15) | 1226 participants (14 studies) | ⊕⊕⊝⊝ | ||
| Disability Follow‐up Lower scores = lower reported disability | The mean disability in the intervention group was 0.27 lower (95% CI ‐0.49 to ‐0.06) | 866 participants (9 studies) | ⊕⊕⊝⊝ | ||
| Anxiety Post‐treatment Lower scores = lower reported anxiety | The mean anxiety in the intervention group was 0.16 lower (95% CI ‐0.29 to ‐0.03) | 883 participants (8 studies) | ⊕⊕⊝⊝ | ||
| Anxiety Follow‐up Lower scores = lower reported anxiety | The mean anxiety in the intervention group was 0.01 lower (95% CI ‐0.20 to 0.18) | 805 participants (8 studies) | ⊕⊕⊝⊝ | ||
| Depression Post‐treatment Lower scores = lower reported depression | The mean disability in the intervention group was 0.05 lower (95% CI ‐0.23 to 0.12) | 757 participants (8 studies) | ⊕⊝⊝⊝ | ||
| CI: Confidence interval. | |||||
| GRADE Working Group grades of evidence | |||||
| a50 to 75% risk of bias ratings were unclear/high. bConfidence intervals were wide. cHeterogeneity (I2) was 46 to 65%. dHeterogeneity (I2) was 66 to 100%. e50 to 75% of studies eligible to be included in the analysis were not included in the analysis. fAsymmetrical funnel plots suggesting publication bias. | |||||
| Headache Studies | |||
|---|---|---|---|
| Author | Illness | Treatment duration (hours) | Setting |
| Headache | 1.5 | Clinic | |
| Headache | 3 | Unknown | |
| Headache | 7 | Clinic | |
| Headache | Unknown | Unknown | |
| Headache | 4 hours plus tasks | Home | |
| Headache | 6.75 | Clinic | |
| Headache | 12 | Home/clinic | |
| Headache | 2.8 | Home/clinic | |
| Mixed | 136.5 (3‐week intensive therapy) | Clinic | |
| Headache | 12 | Clinic | |
| Headache | 6.7 | Clinic | |
| Headache | 7.5 | Clinic | |
| Headache | 6.75 | School | |
| Headache | 5 | School | |
| Headache | Unknown | Home | |
| Headache | 3.3 | Clinic | |
| Headache | 6 | Unknown | |
| Headache | 8 | Home/clinic | |
| Headache | 9.3 | Clinic | |
| Headache | 2.5 | School | |
| Mixed | 5 | Home/clinic | |
| Headache | 13 | Clinic | |
| Headache | 9 | Unknown | |
| Headache | Unknown | Clinic | |
| Headache | 4 | Clinic | |
| Mixed | 10 | Clinic | |
| Mixed Chronic Pain Studies | |||
| Author | Illness | Treatment duration hours) | Setting |
| RAP | Unknown | Clinic | |
| SCD | 6 | Home | |
| SCD | 9.5 | Home/clinic | |
| RAP | 3.3 | Unknown | |
| SCD | 0.75 | Clinic | |
| IBD | 4 | Home | |
| RAP | 9 | Clinic | |
| RAP/IBS | 2 | Clinic | |
| Mixed | 136.5 (3‐week intensive therapy) | Clinic | |
| RAP | Unknown | Clinic | |
| Fibromyalgia | 6 | Clinic | |
| Fibromyalgia | 7.5 | Unknown | |
| RAP | 4 | Home/clinic | |
| IBD | 3.5 | Home/clinic | |
| RAP | 3 | Home/clinic | |
| Mixed | 5 | Home/clinic | |
| RAP | 3.5 | Clinic | |
| RAP | 6 | Clinic | |
| RAP | 4.5 | Clinic | |
| RAP | 1.8 | Home | |
| RAP/IBS | 5 | Clinic | |
| TMD | Unknown | Unknown | |
| TMD | 6 | Clinic | |
| Mixed | 10 | Clinic | |
| *Headache and mixed chronic pain studies were entered twice. | |||
| Psychological treatments for children and adolescents with headache pain | ||||
| Pain | Disability | Depression | Anxiety | |
| Post‐treatment | Effect (15) | No effect (6) | No effect (6) | No effect (7) |
| < 20/arm | Effect (13) | No effect (2) | No effect (3) | No effect (4) |
| > 20/arm | Effect (2) | Effect (4) | No effect (3) | No effect (3) |
| Follow‐up | No effect (5) | Effect (3) | No effect (3) | No effect (4) |
| < 20/arm | Effect (4) | Unknown* | Unknown* | No effect (2) |
| > 20/arm | Unknown* | Effect (2) | No effect (2) | No effect (2) |
| Psychological treatments for children and adolescents with mixed pain conditions | ||||
| Pain | Disability | Depression | Anxiety | |
| Post‐treatment | Effect (16) | Effect (14) | No effect (8) | Effect (8) |
| < 20/arm | Effect (7) | Effect (6) | No effect (2) | Unknown* |
| > 20/arm | No effect (9) | Effect (8) | No effect (6) | Effect (7) |
| Follow‐up | No effect (9) | Effect (9) | No effect (7) | No effect (8) |
| < 20/arm | Effect (2) | No effect (2) | Unknown* | Unknown* |
| > 20/arm | No effect (7) | Effect (7) | No effect (6) | No effect (7) |
| Unknown (no data); Unknown* (only one study); Number in brackets denotes number of studies in analysis. | ||||
| Outcome | Sensitivity analysis |
| Pain, children with headache, post‐treatment | RR 2.79, 95% CI 2.01 to 3.89; participants = 325; studies = 15; I2 = 56% |
| N < 20 | RR 2.79, 95% CI 2.01 to 3.89; participants = 325; studies = 15; I2 = 56% |
| N > 20 | No studies could be included in the analysis |
| Pain, children with mixed pain conditions, post‐treatment | SMD ‐0.57, 95% CI ‐0.90 to ‐0.24; participants = 671; studies = 16; I2 = 74% |
| N < 20 | SMD ‐0.84, 95% CI ‐1.27 to ‐0.41; participants = 221; studies = 7; I2 = 54% |
| N > 20 | SMD ‐0.31, 95% CI ‐0.73 to 0.12; participants = 450; studies = 9; I2 = 79% |
| Disability, children with mixed pain conditions, post‐treatment | SMD ‐0.37, 95% CI ‐0.64 to ‐0.11; participants = 687; studies = 14; I2 = 60% |
| N < 20 | SMD ‐0.67, 95% CI ‐1.21 to ‐0.13; participants = 184; studies = 6; I2 = 64% |
| N > 20 | SMD ‐0.21, 95% CI ‐0.41 to ‐0.00; participants = 503; studies = 8; I2 = 25% |
| CI: confidence intervals | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Pain Show forest plot | 15 | 644 | Risk Ratio (M‐H, Random, 95% CI) | 2.35 [1.67, 3.30] |
| 1.1.1 N < 20 | 13 | 437 | Risk Ratio (M‐H, Random, 95% CI) | 2.86 [1.73, 4.72] |
| 1.1.2 N > 20 | 2 | 207 | Risk Ratio (M‐H, Random, 95% CI) | 1.88 [1.36, 2.58] |
| 1.2 Disability Show forest plot | 6 | 446 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.26 [‐0.56, 0.03] |
| 1.2.1 N < 20 | 2 | 61 | Std. Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.47, 0.54] |
| 1.2.2 N > 20 | 4 | 385 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.35 [‐0.69, ‐0.00] |
| 1.3 Depression Show forest plot | 6 | 400 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.08 [‐0.28, 0.11] |
| 1.3.1 N < 20 | 3 | 103 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.16 [‐0.68, 0.35] |
| 1.3.2 N > 20 | 3 | 297 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.06 [‐0.29, 0.17] |
| 1.4 Anxiety Show forest plot | 7 | 439 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.11 [‐0.39, 0.17] |
| 1.4.1 N < 20 | 4 | 136 | Std. Mean Difference (IV, Random, 95% CI) | 0.01 [‐0.54, 0.57] |
| 1.4.2 N > 20 | 3 | 303 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.19 [‐0.49, 0.11] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Pain Show forest plot | 5 | 223 | Risk Ratio (M‐H, Random, 95% CI) | 2.73 [0.98, 7.63] |
| 2.1.1 N < 20 | 4 | 99 | Risk Ratio (M‐H, Random, 95% CI) | 3.49 [1.31, 9.26] |
| 2.1.2 N > 20 | 1 | 124 | Risk Ratio (M‐H, Random, 95% CI) | 1.25 [1.03, 1.52] |
| 2.2 Disability Show forest plot | 3 | 209 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.37 [‐0.65, ‐0.10] |
| 2.2.1 N < 20 | 1 | 24 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.45 [‐1.27, 0.36] |
| 2.2.2 N > 20 | 2 | 185 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.36 [‐0.65, ‐0.07] |
| 2.3 Depression Show forest plot | 3 | 228 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.05 [‐0.62, 0.52] |
| 2.3.1 N < 20 | 1 | 24 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.54 [‐1.36, 0.28] |
| 2.3.2 N > 20 | 2 | 204 | Std. Mean Difference (IV, Random, 95% CI) | 0.11 [‐0.61, 0.83] |
| 2.4 Anxiety Show forest plot | 4 | 271 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.12 [‐0.46, 0.21] |
| 2.4.1 N < 20 | 2 | 67 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.28 [‐1.00, 0.45] |
| 2.4.2 N > 20 | 2 | 204 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.04 [‐0.48, 0.41] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Pain Show forest plot | 16 | 1210 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.43 [‐0.67, ‐0.19] |
| 3.1.1 N < 20 | 7 | 250 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.83 [‐1.19, ‐0.46] |
| 3.1.2 N > 20 | 9 | 960 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.20 [‐0.45, 0.05] |
| 3.2 Disability Show forest plot | 14 | 1226 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.34 [‐0.54, ‐0.15] |
| 3.2.1 N < 20 | 6 | 213 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.72 [‐1.17, ‐0.26] |
| 3.2.2 N > 20 | 8 | 1013 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.20 [‐0.37, ‐0.04] |
| 3.3 Depression Show forest plot | 8 | 757 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.05 [‐0.23, 0.12] |
| 3.3.1 N < 20 | 2 | 59 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.27 [‐0.95, 0.41] |
| 3.3.2 N > 20 | 6 | 698 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.03 [‐0.21, 0.15] |
| 3.4 Anxiety Show forest plot | 8 | 957 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.16 [‐0.29, ‐0.03] |
| 3.4.1 N < 20 | 1 | 32 | Std. Mean Difference (IV, Random, 95% CI) | 0.12 [‐0.57, 0.82] |
| 3.4.2 N > 20 | 7 | 925 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.17 [‐0.30, ‐0.04] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 4.1 Pain Show forest plot | 9 | 833 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.08 [‐0.30, 0.13] |
| 4.1.1 N < 20 | 2 | 53 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.94 [‐1.75, ‐0.13] |
| 4.1.2 N > 20 | 7 | 780 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.00 [‐0.15, 0.14] |
| 4.2 Disability Show forest plot | 9 | 935 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.27 [‐0.49, ‐0.06] |
| 4.2.1 N < 20 | 2 | 53 | Std. Mean Difference (IV, Random, 95% CI) | ‐1.17 [‐2.60, 0.26] |
| 4.2.2 N > 20 | 7 | 882 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.20 [‐0.34, ‐0.07] |
| 4.3 Depression Show forest plot | 7 | 667 | Std. Mean Difference (IV, Random, 95% CI) | 0.09 [‐0.10, 0.28] |
| 4.3.1 N < 20 | 1 | 24 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.53 [‐1.35, 0.29] |
| 4.3.2 N > 20 | 6 | 643 | Std. Mean Difference (IV, Random, 95% CI) | 0.12 [‐0.06, 0.30] |
| 4.4 Anxiety Show forest plot | 8 | 875 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.01 [‐0.20, 0.18] |
| 4.4.1 N < 20 | 1 | 32 | Std. Mean Difference (IV, Random, 95% CI) | 0.09 [‐0.60, 0.79] |
| 4.4.2 N > 20 | 7 | 843 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.01 [‐0.22, 0.19] |
