About this trial
Vaginismus, a condition characterized by involuntary tightening of the pelvic floor muscles due to strong fear of vaginal insertion, impact ≥6% of the female population and can make vaginal intercourse and medical exams difficult. This project explores virtual reality exposure (VRE) as a new treatment approach. Building on our two previous studies showing that VRE is feasible and effective in helping patients to gradually face feared sexual encounters in a virtual environment, we aim to implement our VRE protocol at the BC Centre for Vulvar Health (BCCVH). We will assess barriers/facilitators to implementation, clinician uptake, and patients' outcomes and engagement.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of vaginismus defined by a "marked fear or anxiety about vulvovaginal or pelvic pain in anticipation of, during, or because of vaginal penetration" (criterion from the DSM-5 definition of Genito-Pelvic Pain Penetration Disorder)
Aged >19 y, of any sexual orientation
Fluent in English (psychoeducational materials and questionnaires delivered in English)
Normal or corrected-to-normal vision (to view the VR scenes during exposure)
Disqualifiers
Presence of: unprovoked vaginal pain
Vulvar skin condition (i.e., lichen sclerosus)
Epilepsy characterized by photosensitive seizures.
Trial design
Single group
Treatments tested in this trial
Implementation of Virtual Reality Exposure
BehavioralTo inform implementation, clinicians at BCCVH (n=6) will participate in individual semi-structured interviews prior to implementation to identify barriers and facilitators. Findings from these interviews will refine the implementation protocol. Following implementation, clinicians will complete questionnaires assessing implementation outcomes, including adoption, implementation, and maintenance. Participants (n=167) will receive a single VRE session in addition to standard clinical care at the BCCVH. The VRE session is designed to support treatment of vaginismus and will be delivered according to the study protocol. Participants will complete study questionnaires at baseline and follow-up.
Treatment groups
Trial outcomes
Primary outcomes
VRE session duration
Time duration of a VRE session will be measured from start to end of each VRE sessions in minutes and logged by facilitators in an Excel session log.
Staff time & resource utilization
Staff time, personnel type and equipment used per VRE session will be measured each VRE session and logged by facilitator in an Excel session log.
Cost of VRE delivery
Estimated cost per session based on staff time, equipment and other resources used to deliver VRE will be calculated from the Excel resource-use log.
Technical challenges & adaptations
Number and types of technical challenges encountered when conducting VRE session, and adaptations to protocol made as a result. This will be documented in an Excel study log.
Secondary outcomes
Mean change from baseline in State-Trait Inventory for Cognitive and Somatic Anxiety-State score
Participants will answer the State-Trait Inventory for Cognitive and Somatic Anxiety, a 21-item measure, 48 hours before the VRE session, 48 hours after the VRE session, and 6-months following the VRE session. Change will be calculated separately from baseline (48 hours before the VRE session) to 48 hours and 6 months after the VRE session.
Mean change from baseline in Vaginal Penetration Cognition score
Participants will answer the Vaginal Penetration Cognition Questionnaire, a 40-item questionnaire, 48 hours before the VRE session, 48 hours after the VRE session, and 6-months following the VRE session. Change will be calculated separately from baseline (48 hours before the VRE session) to 48 hours and 6 months after the VRE session.
Mean change from baseline in Female Sexual Distress score
Participants will answer the Female Sexual Distress Scale-Revised, a 13-item questionnaire, 48 hours before the VRE session, 48 hours after the VRE session, and 6-months following the VRE session. Change will be calculated separately from baseline (48 hours before the VRE session) to 48 hours and 6 months after the VRE session.
Mean change from before to after VRE in Shortened State scale of the State-Trait Anxiety Inventory score
Participants will answer the Shortened State scale of the State-Trait Anxiety Inventory, a 6-item measure, immediately before and immediately after completing the VRE session. Change will be calculated as the immediately post-VRE score to immediately pre-VRE score.
Sponsors and contacts
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