An interventional study of Implementation of Virtual Reality Exposure in Vaginismus and Difficulties With Vaginal Penetration, sponsored by University of British Columbia. Not yet recruiting at 1 site in Canada. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
PURPOSE: Vaginismus is a gynecologic condition characterized by involuntary tightening of the pelvic floor muscles. It is defined by intense fear of vaginal insertion, leading to persistent difficulties with vaginal intercourse and gynaecological exams The anticipation of pain provokes hypervigilance, negative cognitions, and avoidance behaviour, leading vaginismus to be conceptualized as a phobia. Equipped with data from Studies 1 and 2 from our 3-stage program for VRE to treat vaginismus, we have demonstrated that our VRE paradigm is feasible to deliver, usable, satisfactory to participants, and highly efficacious. We are now ideally positioned to evaluate the implementation of our VRE paradigm at VCH's BCCVH, which offers multidisciplinary treatment for individuals with chronic and distressing vulvo-vaginal pain and fear of vaginal insertion. Our goal is to use implementation science to study the phased implementation of our VRE protocol within the BCCVH, ultimately leading to better treatment options for women with vaginismus.
JUSTIFICATION: Lack of effective treatments: While vaginismus is common, believed to impact 6% of the female population, it remains underdiagnosed, effective treatment options are limited, and patients often feel dismissed by care providers. Available psychological treatments for vaginismus rely on gradual self-insertion of vaginal dilators at home combined with psychological therapy. However, many individuals experience severe fear and avoidance that make it difficult to engage with these exercises, reducing treatment success. VRE Theoretical approach: This project uses a theoretical approach recognizing that the psychological fear of pain drives hypervigilance to sexual stimuli, leading to physiological responses such as tightening of the pelvic floor muscles which in turn causes physical pain. Thus, addressing fear is a key piece of managing this condition and can be achieved through fear extinction approaches such as exposure therapy. Traditionally, this approach involves repeatedly exposing an individual to the fear-inducing stimulus until their fear decreases (habituates). When exposure is successful, a new association develops and inhibits the retrieval of the original fear memory. Our VRE paradigm is built upon this theory. VRE immerses people in 3D simulations of feared situations and is as effective as real-life exposure for specific phobias. VRE for vaginismus is gradual exposure to feared sexual encounters in a virtual environment and can diminish phobic responses to vaginal insertion. Given that people with vaginismus cope via intense avoidance and often do not perform recommended at-home exposure exercises, the "immersive" nature of VRE ideally target this avoidance.
PROOF OF CONCEPT: Findings from Study 1 \& 2 of this 3-stage VRE research program showed that: 1) VR sexual stimuli elicit a greater fear in individuals with vaginismus relative to individuals without, 2) most participants would participate in a VRE intervention in clinic if it was available, and 3) participants strongly support the efficacy of the VRE approach. Together, these findings support the readiness to move forward with preparing for clinic implementation of this approach. The BCCVH is a provincial referral centre providing interdisciplinary, evidence-based care for vulvar and pelvic pain conditions, seeing 250 new patients each year. Its established clinical infrastructure, patient volume, and commitment to innovation make it an ideal setting to evaluate the implementation of VRE within existing clinic workflow.
OBJECTIVES: Our goal is to use implementation science to study the phased implementation of our VRE protocol within the BCCVH. The specific aims are to: (1) Conduct a barriers/facilitators assessment; (2) Evaluate clinician uptake, feasibility, and acceptability with pilot implementation of VRE; and (3) Assess patient reported outcomes of anxiety, sexual distress, pain, and home treatment engagement after VRE.
29 studies on the registry are indexed under Vaginismus; 9 are open to participants now.
This study's planned enrollment of 167 is above the median of 40 across 23 interventional studies indexed under Vaginismus.
Browse Vaginismus studies →University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Note: provoked vulvar pain is not an exclusion criterion because at least 40% of people with vaginismus report pain with attempted penetration.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
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
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed yearly through study completion, 20 months.
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.
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.
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.
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.
Igroup Presence Questionnaire score
Participants will answer the Igroup Presence Questionnaire, a 14-item questionnaire, immediately after completing the VRE session. Score will indicate the sense of presence in the virtual environment experienced by the participant.
Time frame: Immediately after VRE session.
Reported ease of vaginal accommodator insertion
Participants who choose to attempt vaginal accommodator insertion during the VRE session will rate the ease of insertion on a scale from 0 to 10, where 0 indicates "unable to insert-too difficult" and 10 indicates "could insert with ease".
Time frame: Immediately after VRE, if optional vaginal accommodator insertion attempted.
Reported pain with vaginal accommodator insertion
Participants who choose to attempt vaginal accommodator insertion during the VRE session will rate the pain with insertion on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst possible pain".
Time frame: Immediately after VRE, if optional vaginal accommodator insertion attempted.
Plan to share: No
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Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
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