NCT07747298

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

August 5, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 7, 2026

Last Update Submit

July 30, 2026

Conditions

Difficulties With Vaginal PenetrationVaginismus

Keywords

Virtual realityDigital healthSexual healthImplementation scienceVaginismus

Outcome Measures

Primary Outcomes (9)

  • 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.

    Assessed every session through study completion, 20 months

  • 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.

    Assessed every session through study completion, 20 months

  • 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.

    Assessed at study completion

  • 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.

    Assessed every session through study completion, 20 months.

  • Fidelity of VRE delivery

    Percentage of planned VRE components delivered as intended. Measured using an Excel fidelity log completed by facilitator that conducts VRE session.

    Assessed every session through study completion, 20 months.

  • Clinicians trained in VRE delivery

    Number and proportion of eligible clinicians and staff members receiving training for VRE session delivery. Measured by training attendance log.

    Assessed at time of training (unknown for now).

  • Adoption of VRE

    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.

    Assessed 6-months and 12-months after implementation.

  • Maintenance of VRE

    Clinicians will answer questionnaires on their intention to use VRE, confidence implementing VRE, and perceived skills and readiness to implement VRE.

    Assessed before implementation, 6-months and 12-months after implementation.

  • Reach

    Number of patients seen in one year at the BCCVH who are offered and accept the VRE session.

    Assessed yearly through study completion, 20 months.

Secondary Outcomes (7)

  • Mean change from baseline in State-Trait Inventory for Cognitive and Somatic Anxiety-State score

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

  • Mean change from baseline in Vaginal Penetration Cognition score

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

  • Mean change from baseline in Female Sexual Distress score

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

  • Mean change from before to after VRE in Shortened State scale of the State-Trait Anxiety Inventory score

    Immediately before VRE session and immediately after VRE session.

  • Igroup Presence Questionnaire score

    Immediately after VRE session.

  • +2 more secondary outcomes

Study Arms (1)

Implementation of Virtual reality exposure

EXPERIMENTAL

The investigators designed the VRE protocol based on our two studies: one proof-of-concept study, and a second study measuring VRE efficacy (both manuscripts under review). We found our VRE protocol to be highly feasible, usable, satisfying, and to lead to significant improvements in our outcomes focused on ease of vaginal insertion and associated vaginal pain. Participants will take part in a one-time 120-minute session, in addition to standard clinical care at the BCCVH, and complete study questionnaires before the VRE session and at follow-up time points to evaluate clinical outcomes. The VRE session will adhere to 3 key principles: (i) Exposure is prolonged; patients view a sexual scene multiple times; (ii) Treatment proceeds gradually, with the sexual activities depicted moving from non-penetrative (low fear) to penetrative (high fear); and (iii) Exposures are repeated, with participants re-watching the videos until their fear response has habituated.

Behavioral: Implementation of Virtual Reality Exposure

Interventions

Implementation of Virtual Reality ExposureBEHAVIORAL

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.

Implementation of Virtual reality exposure

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Able to travel to Vancouver

You may not qualify if:

  • Presence of: unprovoked vaginal pain
  • Vulvar skin condition (i.e., lichen sclerosus)
  • Epilepsy characterized by photosensitive seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Vaginismus

Condition Hierarchy (Ancestors)

Vaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Lori Brotto

    The University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Selden

CONTACT

604-875-4111lselden@student.ubc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study is guided by the National Implementation Research Framework's Active Implementation Frameworks, in particular the Exploration phase. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework will guide evaluation of outcome measures. Implementation of virtual reality exposure (VRE) therapy for vaginismus at the BC Centre for Vulvar Health (BCCVH) will be informed by semi-structured interviews with clinicians (n=6) to identify barriers and facilitators to implementation. Patients receiving care at the BCCVH will be offered a single VRE session in addition to standard clinical care. Patient outcomes will be assessed at baseline and 6 months following the intervention. Clinician implementation outcomes, including adoption, implementation, and maintenance, will be assessed at and baseline and at 6 and 12 months following implementation at the BCCVH.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Licensed Psychologist

Study Record Dates

First Submitted

July 7, 2026

First Posted

August 5, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

August 5, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)