Intervenciones para reducir la ansiedad en las mujeres que se someten a una colposcopia
References
Referencias de los estudios incluidos en esta revisión
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Referencias de los estudios excluidos de esta revisión
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Referencias adicionales
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Characteristics of studies
Characteristics of included studies [ordered by study ID]
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| Study characteristics | ||
| Methods | Randomised, parallel group design. | |
| Participants | 196 women (aged between 20 to 60 yrs.) referred for colposcopy for the first time with moderate dyskaryosis or less were randomised. | |
| Interventions | All women received locally produced information leaflet and counselling by colposcopy nurse. Intervention group received an additional counselling session that lasted 60‐90 minutes. These sessions were held in the evening and were led by an experienced colposcopic nurse who had training in counselling. The sessions were group sessions they lasted for 60‐90 minutes during which information video about colposcopy was shown. | |
| Outcomes | Anxiety was measured using STAI, General health questionnaire, Abnormal smears questionnaire, Cervical screening questionnaire | |
| Notes | Follow up: six weeks. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Women eligible for the study were initially randomised into two groups by the clinic secretary using a computer‐generated random numbers series". |
| Allocation concealment (selection bias) | Low risk | "Women ... were initially randomised ... using a computer‐generated random numbers series contained within closed opaque envelopes". |
| Blinding (performance bias and detection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) | High risk | % analysed: 100/196 (51%) were assessed at stage one, 125/196 (64%) at stage two and just 59/196 (30%) were assessed at stage 3 of the intervention. |
| Selective reporting (reporting bias) | Low risk | There was no reason to suspect that outcomes had been selectively reported and they appear to be comprehensive. |
| Other bias | Unclear risk | Insufficient information to assess whether an additional risk of bias exists. |
| Study characteristics | ||
| Methods | Randomised, parallel group design. Analysis of the results was not done on an intention‐to‐treat basis. | |
| Participants | 220 women with smear abnormality attending colposcopy clinic for the first time were randomised. Women with mental impairment and pregnant women were excluded. | |
| Interventions | Women's favourite music played through speakers during colposcopic examination. For the control group no music was played. | |
| Outcomes | Anxiety was measured using STAI, and knowledge was measured using questionnaire immediately post colposcopy. Pain was assessed using visual analogue scale (VAS). Outcomes were measure just prior to the colposcopy and immediately afterwards. | |
| Notes | Drop out rates were similar in the intervention and control groups. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Subjects were randomly assigned ... using a computer‐generated random number series". |
| Allocation concealment (selection bias) | Low risk | "Computer‐generated random number series contained within closed opaque envelopes". |
| Blinding (performance bias and detection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) | Low risk | % analysed: 220/220 (100%) |
| Selective reporting (reporting bias) | Low risk | There was no reason to suspect that outcomes had been selectively reported and they appear to be comprehensive. |
| Other bias | Unclear risk | Insufficient information to assess whether an additional risk of bias exists. |
| Study characteristics | ||
| Methods | Randomised, parallel group design. Analysis of the results was not done on an intention‐to‐treat basis. | |
| Participants | 220 women with mild to moderate dyskaryosis on smear attending colposcopy clinic for the first time were randomised. Women with mental impairment were excluded. | |
| Interventions | Locally produced information leaflet followed by watching information video given to both groups. Intervention group received counselling further explanation and discussion by experienced colposcopy nurse. | |
| Outcomes | Anxiety was measured using STAI, and knowledge of the procedure using a questionnaire. Outcomes were measure just prior to the intervention and immediately after the colposcopy. | |
| Notes | One year follow up clinical data. Drop out rates were similar in the intervention and control groups. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Eligible subjects were randomly assigned ... using a computer‐generated random number series". |
| Allocation concealment (selection bias) | Low risk | "Eligible subjects were randomly assigned ... using a computer‐generated random number series contained within closed opaque envelopes". |
| Blinding (performance bias and detection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) | Low risk | % analysed: 220/220 (100%) |
| Selective reporting (reporting bias) | Low risk | There was no reason to suspect that outcomes had been selectively reported and they appear to be comprehensive. |
| Other bias | Unclear risk | Insufficient information to assess whether an additional risk of bias exists. |
| Study characteristics | ||
| Methods | RCT, Parallel design. Single centre study. Analysis of the results was not on an intention‐to‐treat basis. | |
| Participants | 132 women with moderate to severe dyskaryosis attending colposcopy clinic for the first time were randomised. | |
| Interventions | All women received information leaflet. Intervention group received information leaflet and an information video that lasted for 7 minutes. | |
| Outcomes | Anxiety was measured using STAI at first attendance and after intervention. | |
| Notes | Loss to follow‐up, 16 in the intervention group and 23 in the control group. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "All new referrals ... were randomly allocated to receive either the explanatory video or the standard information". The method of sequence generation was not reported. |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) | High risk | % analysed: 93/132 (70%) |
| Selective reporting (reporting bias) | Low risk | There was no reason to suspect that outcomes had been selectively reported and they appear to be comprehensive. |
| Other bias | Unclear risk | Insufficient information to assess whether an additional risk of bias exists. |
| Study characteristics | ||
| Methods | Randomised, parallel group design. Results not analysed on an intention‐to‐treat basis. | |
| Participants | 210 women, with no previous colposcopy and cytological abnormality no greater than moderate dyskaryosis were randomised. | |
| Interventions | Those agreeing to take part were interviewed before the routine pre‐colposcopy counselling by two authors (T.I, P.D) who were unaware whether they received information leaflets. | |
| Outcomes | Each patient completed STAI and modified psychosexual questionnaire. | |
| Notes | Follow‐up for 6 months. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Initially 210 consecutive patients were assigned to one of two groups by the clinic manager using a computer derived random number series". |
| Allocation concealment (selection bias) | Low risk | "Patients were assigned ... using a computer derived random number series contained within closed opaque envelopes". |
| Blinding (performance bias and detection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) | High risk | % analysed: 200/210 (95%) were assessed at first visit and 143/210 (68%) were assessed at second visit. |
| Selective reporting (reporting bias) | Low risk | There was no reason to suspect that outcomes had been selectively reported and they appear to be comprehensive. |
| Other bias | Unclear risk | Insufficient information to assess whether an additional risk of bias exists. |
| Study characteristics | ||
| Methods | Randomised, parallel group design. Results not analysed on an intention‐to‐treat basis. | |
| Participants | 124 women with mild to severe cervical abnormalities attending colposcopy clinic for the first time were randomised. | |
| Interventions | Control group: | |
| Outcomes | Anxiety was measured using STAI, knowledge assessed using questionnaire. Outcomes were measured just prior to the intervention and after the colposcopy. | |
| Notes | Drop out rates were similar in the intervention and control groups. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "A total of 124 women ... were randomly allocated to one of four groups". The method of sequence generation was not reported. |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) | High risk | % analysed: 28/62 (45%) |
| Selective reporting (reporting bias) | Low risk | There was no reason to suspect that outcomes had been selectively reported and they appear to be comprehensive. |
| Other bias | Unclear risk | Insufficient information to assess whether an additional risk of bias exists. |
Characteristics of excluded studies [ordered by study ID]
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| Study | Reason for exclusion |
| Not on interventions to reduce anxiety. | |
| Randomised, double blind parallel group design. Computer randomisation numbers generated. Block allocation | |
| RCT comparing music or guided imagery versus usual care for women undergoing colposcopy. However, 32% of 170 women in the trial had received previous colposcopy. | |
| This was not a randomised controlled trial | |
| Quasi‐randomised trial which included 147 women with cervical abnormalities attending colposcopy clinic for the first time. Women with previous diagnosis of smear abnormalities and women who had hysterectomy were excluded. The trial compared information given verbally without teaching aids, information given verbally and in graph form, verbal information with information video of colposcopy and women who were given information only if they asked for it (control group). | |
| Not an interventions to reduce anxiety. | |
| Not an interventions to reduce anxiety. The control group had a smear at their GP practice. | |
| This study did not investigate an intervention to reduce anxiety. | |
| Not treatment for anxiety | |
| Two studies (randomised) reported in one paper, but patients included adolescent females between the age of 13‐20 years, so a substantial number would have been under the age of 18 years. The anxiety scales were self reported and no validated scale such as STAI was used. | |
| Quasi‐randomised trial comparing counselling with no counselling at a colposcopy clinic. The primary objectives of this trial were to assess the emotional well‐being of women with a positive smear. | |
| Quasi‐randomised trial which included 103 women attending colposcopy for the first time. The trial compared information leaflets (given to women in intervention group one week before colposcopy) with no information leaflet. | |
| Quasi‐randomised trial which included 81 women between 20 and 40 years of age, with abnormal smears attending colposcopy for the first time. The trial compared video colposcopy where the participant was able to observe a monitor presenting real time images of the cervix during procedure with no video colposcopy. |
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Anxiety levels (STAI) Show forest plot | 2 | 228 | Mean Difference (IV, Random, 95% CI) | ‐3.28 [‐13.29, 6.74] |
| Analysis 1.1  Comparison 1: Information leaflets versus no information leaflets, Outcome 1: Anxiety levels (STAI) | ||||
| 1.2 Knowledge scores Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| Analysis 1.2  Comparison 1: Information leaflets versus no information leaflets, Outcome 2: Knowledge scores | ||||
| 1.3 Psychosexual dysfunction Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| Analysis 1.3  Comparison 1: Information leaflets versus no information leaflets, Outcome 3: Psychosexual dysfunction | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Anxiety levels (STAI) Show forest plot | 2 | 345 | Mean Difference (IV, Random, 95% CI) | ‐1.29 [‐3.80, 1.22] |
| Analysis 2.1  Comparison 2: Information leaflets and video + counselling vs. information leaflets and video + no counselling, Outcome 1: Anxiety levels (STAI) | ||||
| 2.2 Knowledge scores Show forest plot | 2 | 345 | Mean Difference (IV, Random, 95% CI) | 0.76 [‐0.33, 1.85] |
| Analysis 2.2  Comparison 2: Information leaflets and video + counselling vs. information leaflets and video + no counselling, Outcome 2: Knowledge scores | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Anxiety levels (STAI) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| Analysis 3.1  Comparison 3: Music during colposcopy versus no music, Outcome 1: Anxiety levels (STAI) | ||||
| 3.2 Pain experienced during procedure (VAS) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| Analysis 3.2  Comparison 3: Music during colposcopy versus no music, Outcome 2: Pain experienced during procedure (VAS) | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 4.1 Anxiety levels Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| Analysis 4.1  Comparison 4: Information leaflets + information video vs. Information leaflets only, Outcome 1: Anxiety levels | ||||
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Comparison 1: Information leaflets versus no information leaflets, Outcome 1: Anxiety levels (STAI)
Comparison 1: Information leaflets versus no information leaflets, Outcome 2: Knowledge scores
Comparison 1: Information leaflets versus no information leaflets, Outcome 3: Psychosexual dysfunction
Comparison 2: Information leaflets and video + counselling vs. information leaflets and video + no counselling, Outcome 1: Anxiety levels (STAI)
Comparison 2: Information leaflets and video + counselling vs. information leaflets and video + no counselling, Outcome 2: Knowledge scores
Comparison 3: Music during colposcopy versus no music, Outcome 1: Anxiety levels (STAI)
Comparison 3: Music during colposcopy versus no music, Outcome 2: Pain experienced during procedure (VAS)
Comparison 4: Information leaflets + information video vs. Information leaflets only, Outcome 1: Anxiety levels
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Anxiety levels (STAI) Show forest plot | 2 | 228 | Mean Difference (IV, Random, 95% CI) | ‐3.28 [‐13.29, 6.74] |
| 1.2 Knowledge scores Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.3 Psychosexual dysfunction Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Anxiety levels (STAI) Show forest plot | 2 | 345 | Mean Difference (IV, Random, 95% CI) | ‐1.29 [‐3.80, 1.22] |
| 2.2 Knowledge scores Show forest plot | 2 | 345 | Mean Difference (IV, Random, 95% CI) | 0.76 [‐0.33, 1.85] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Anxiety levels (STAI) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 3.2 Pain experienced during procedure (VAS) Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 4.1 Anxiety levels Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
