Van Lankveld 2006b.
Methods | Design: randomised controlled trial Allocation method: urn randomisation (stratified design) Blinding: assessor blind | |
Participants | Diagnosis: primary vaginismus Criteria: DSM‐IV‐TR Setting: outpatient clinic Number: 33 Age: 30.6 years, SD = 7.5 Duration of vaginismus: 127 months, SD = 65 | |
Interventions | Intervention 1: bibliotherapy + minimal contact
Number of sessions: 6
Duration of sessions: 15
Therapist level: NA
Adjunctive interventions: NA Intervention 2: bibliotherapy + group therapy Number of sessions: 10 Duration of sessions: 120 minutes Therapist level: senior therapist Adjunctive interventions: not stated |
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Outcomes | Successful intercourse Drop‐outs Primary endpoint questionnaire Female Sexual Function Index Maudsley Marital Questionnaire Golombok Rust Inventory of Sexual Satisfaction | |
Notes | Subjects were re‐randomised waiting list from Van Lankveld 2006a | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "A person not involved in assessment or treatment delivery performed urn randomisation." |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Blinding was not possible for participants or therapists. However, most assessors were blinded to treatment status ‐ "assessment was performed at each research center by two research assistants who were not involved in treatment delivery and who were blinded to the treatment condition of participants, with the exception of one of two assessors in one research center, who was also involved in treatment delivery." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 10 of 33 participants dropped out of treatment. Drop‐outs were not equivalent across the different treatment arms of the study (3 out of 13 left the group treatment (23%) compared to 7 out of 20 (35%) in the minimal contact group). Investigators used LOCF (last observation carried forward) to impute missing data for drop‐outs |
Selective reporting (reporting bias) | Unclear risk | Outcome data provided for all stated outcomes but we have no access to study protocols so cannot be certain other outcomes were not assessed |
Other bias | Low risk | None suspected |