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

Condition(s) studied

Investigational drug(s) / intervention(s)

Implementation of Virtual Reality Exposure: 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.

Study summary

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

Primary outcome measure(s)

• VRE session duration — Assessed every session through study completion, 20 months
  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 — Assessed every session through study completion, 20 months
  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 — Assessed at study completion
  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 — Assessed every session through study completion, 20 months.
  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.
• Fidelity of VRE delivery — Assessed every session through study completion, 20 months.
  Percentage of planned VRE components delivered as intended. Measured using an Excel fidelity log completed by facilitator that conducts VRE session.
• Clinicians trained in VRE delivery — Assessed at time of training (unknown for now).
  Number and proportion of eligible clinicians and staff members receiving training for VRE session delivery. Measured by training attendance log.
• Adoption of VRE — Assessed 6-months and 12-months after implementation.
  Adoption will be measured as the proportion of clinicians who report willingness to incorporate VRE into routine clinical practice following implementation, assessed through a survey.
• Maintenance of VRE — Assessed before implementation, 6-months and 12-months after implementation.
  Clinicians will answer questionnaires on their intention to use VRE, confidence implementing VRE, and perceived skills and readiness to implement VRE.
• Reach — Assessed yearly through study completion, 20 months.
  Number of patients seen in one year at the BCCVH who are offered and accept the VRE session.

Trial sites (1)

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