Implementing Virtual Reality Exposure Therapy for Vaginismus: From Efficacy to Clinical Integration (VIVID 3)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19+
SponsorUniversity of British Columbia

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Implementation of Virtual Reality Exposure

    Behavioral

    To 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

167 Participants
are divided into 1 treatment group
Group A: Implementation of Virtual reality exposureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessed every session through study completion, 20 months
2

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.

Time frame
Assessed every session through study completion, 20 months
3

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.

Time frame
Assessed at study completion
4

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.

Time frame
Assessed every session through study completion, 20 months.

Secondary outcomes

1

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.

Time frame
Baseline at 48 hours before VRE session, 48 hours after VRE session, and 6-months after VRE session.
2

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.

Time frame
Baseline at 48 hours before VRE session, 48 hours after VRE session, and 6-months after VRE session.
3

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.

Time frame
Baseline at 48 hours before VRE session, 48 hours after VRE session, and 6-months after VRE session.
4

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.

Time frame
Immediately before VRE session and immediately after VRE session.

Other outcomes

Sponsors and contacts

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