VaginismusVIVID 3NCT07747298
Implementing Virtual Reality Exposure Therapy for Vaginismus: From Efficacy to Clinical Integration (VIVID 3)
A study testing Implementation of Virtual Reality Exposure in people with Vaginismus and Difficulties With Vaginal Penetration, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Vaginismus, Difficulties With Vaginal Penetration
- What is being tested?
- Implementation of Virtual Reality Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of: unprovoked vaginal pain
- Vulvar skin condition (i.e., lichen sclerosus)
- Epilepsy characterized by photosensitive seizures.
- Note: provoked vulvar pain is not an exclusion criterion because at least 40% of people with vaginismus report pain with attempted penetration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9
Lauren Selden, 604-875-4111 ext. 68901, lselden@student.ubc.ca
About this study
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.
Read the detailed description
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.
- Conditions
- Vaginismus, Difficulties With Vaginal Penetration
- Being tested
- Implementation of Virtual Reality Exposure
- Keywords
- Virtual reality, Digital health, Sexual health, Implementation science, Vaginismus
- Medical subject headings
- Vaginismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of Virtual Reality ExposureBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Implementation of Virtual Reality Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: Immediately after VRE, if optional vaginal accommodator insertion attempted.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginismusStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Brotto, University of British Columbia
- Investigators
- Lori Brotto, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747298
- Sponsor's protocol ID
- H26-01276
- Acronym
- VIVID 3
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Virtual Reality Exposure Therapy for Vaginismus: From Efficacy to Clinical Integration (VIVID 3)
- ClinicalTrials.gov ID
- NCT07747298
- Acronym / sponsor ID
- VIVID 3 / H26-01276
- Conditions
- Vaginismus, Difficulties With Vaginal Penetration
- Keywords
- Virtual reality, Digital health, Sexual health, Implementation science, Vaginismus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Implementation of Virtual reality exposure | Experimental | Behavioral: Implementation of Virtual Reality ExposureThe 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Presence of: unprovoked vaginal pain
- Vulvar skin condition (i.e., lichen sclerosus)
- Epilepsy characterized by photosensitive seizures.
- Note: provoked vulvar pain is not an exclusion criterion because at least 40% of people with vaginismus report pain with attempted penetration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of Virtual Reality ExposureTo 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. | Behavioural | Implementation of Virtual reality exposure |
Primary outcome
VRE session duration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Mean change from baseline in State-Trait Inventory for Cognitive and Somatic Anxiety-State score
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
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
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
Time frame: Immediately before VRE session and immediately after VRE session.
Igroup Presence Questionnaire score
Time frame: Immediately after VRE session.
Reported ease of vaginal accommodator insertion
Time frame: Immediately after VRE, if optional vaginal accommodator insertion attempted.
Reported pain with vaginal accommodator insertion
Time frame: Immediately after VRE, if optional vaginal accommodator insertion attempted.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lori Brotto principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of Virtual Reality Exposure in people with Vaginismus and Difficulties With Vaginal Penetration, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Selden (604-875-4111 ext. 68901, lselden@student.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VRE session duration (time frame: Assessed every session through study completion, 20 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.