Virtual Reality Exposure for Vaginismus

(VIVID 2 Trial)

Recruiting at 1 trial location

Overseen By Kelsey Lynch, MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Unprovoked vaginal pain, Vulvar skin condition, Imperforate hymen, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 3 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for vaginismus, a condition where pelvic muscles tighten involuntarily, making vaginal intercourse difficult or impossible. The study employs virtual reality exposure therapy to gradually expose participants to fear-inducing situations, aiming to reduce the defensive muscle response. The goal is to determine if this approach can lessen fear and improve the condition. Individuals diagnosed with vaginismus who have experienced muscle tightness interfering with vaginal penetration for more than six months might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for vaginismus.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual reality exposure is safe for treating vaginismus?

Previous studies have examined the safety of using virtual reality (VR) with women. Research has shown that VR can be a helpful tool for conditions like vaginismus, where pelvic muscles tighten, making activities like intercourse difficult and painful due to fear.

One study found that women using VR might feel some anxiety when viewing certain scenes. This is expected because the goal is to gradually reduce fear. However, these feelings were manageable with techniques to control anxiety.

Another study examined VR's effects on women during medical procedures and found it to be generally safe and well-tolerated. Most women did not experience serious side effects.

This suggests that while some initial discomfort may occur, VR exposure is considered safe overall. It is designed to gradually help lessen fear responses, improving comfort over time. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality exposure (VRE) for treating vaginismus because it offers a unique, immersive approach to managing this condition. Unlike traditional treatments, which often involve physical therapy or gradual dilation exercises, VRE allows patients to confront and reduce their fear of penetration in a controlled, virtual environment. This method is particularly innovative because it uses a VR headset to simulate sexual scenarios that gradually increase in intensity, helping patients desensitize and reduce anxiety over time. By providing a customizable and private experience, VRE could make treatment more accessible and less intimidating for many individuals.

What evidence suggests that virtual reality exposure is effective for vaginismus?

Research has shown that virtual reality therapy could help treat anxiety disorders, including those related to sexual issues. Early studies suggest that virtual reality can reduce fear by gradually exposing individuals to their fears in a safe environment. In this trial, participants will receive virtual reality exposure combined with psychoeducation to address vaginismus, a condition where pelvic muscles tighten involuntarily. By gradually introducing feared situations, VR exposure might help relax these muscles, reduce intense fear, and improve symptoms. Although more research is needed specifically for vaginismus, early signs are promising. ^{1 6 7 8 9}

Who Is on the Research Team?

Lori Brotto, PhD, RPsych

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for individuals with a vagina, aged over 19, who have been diagnosed with vaginismus—a condition causing involuntary muscle tightness that interferes with vaginal penetration for more than six months. Participants must be fluent in English, have normal or corrected vision to use VR technology and can travel to Vancouver. This includes cisgender women, gender-diverse individuals, transwomen post-surgery, and transmen without bottom surgery.

Inclusion Criteria

The investigators will recruit individuals who have a vagina. They expect that most participants will identify as cisgender, where sex is female and gender is woman, while others may have a female sex but identify as a different gender (e.g., genderdiverse). Transwomen (i.e., birth assigned males but identify as woman) who have had gender-affirming surgery (and so have a vagina) are eligible, as are transmen (i.e., birth assigned females but identify as men) who have not had bottom surgery (so have a vagina).

Inclusion criteria: In addition to having a vagina, participants must have a diagnosis of vaginismus that requires self-reported involuntary tightness of the vaginal musculature that causes persistent interference with vaginal penetration lasting \>6 months; aged \>19 y, of any sexual orientation. Participants must be fluent in English (psychoeducational materials and questionnaires delivered in English), have normal or corrected-to-normal vision (to view the VR scenes during exposure), and be able to travel to Vancouver.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo virtual reality exposure therapy with psychoeducation over 3 weeks, involving 3 x 2-hour sessions

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for ease of vaginal insertion, insertion pain, and frequency of sexual activity at 3-week and 3-month intervals post-treatment

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Exposure

Trial Overview

The study tests if virtual reality exposure therapy can help people overcome the fear of vaginal penetration associated with vaginismus. By gradually exposing participants to feared stimuli through VR technology, the trial aims to reduce the phobic response and improve sexual function.

How Is the Trial Designed?

Group I: Virtual reality exposure plus psychoeducation Experimental Treatment 1 Intervention

The investigators designed the VRE protocol based on interviews from our proof-of-concept study. Participants will take part in 3 x 2-hour sessions over a 3-week period. Treatment will adhere to three key principles: (i) Exposure will be prolonged, such that participants will use a VR headset to view a sexual scene multiple times; (ii) Treatment will proceed gradually, with the sexual activities depicted moving from non-penetrative (low fear) to penetrative (high fear); and (iii) Exposures will be repeated, with participants re-watching the videos until their fear response has habituated (i.e., level of distress = 10-20/100). Prior to their first VRE session, participants will be given access to a website with descriptions and images of a variety of VR sexual videos, which will allow them to select an exposure film based on comfort with/attraction to the virtual actor.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

Virtual reality (VR) exposure therapy has shown promise as an effective and cost-efficient alternative to traditional exposure therapy for treating anxiety disorders, particularly in reducing fear of heights and fear of flying.

The initial controlled studies indicate that VR can successfully immerse participants in a virtual environment, which may enhance therapeutic outcomes for various anxiety-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality exposure therapy. Rothbaum, BO., Hodges, L., Kooper, R.[2012]

Citations

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clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT06923306

NCT06923306 | Virtual Reality Exposure for Vaginismus: A ...

VRE treatment studies for anxiety disorders often include patient psychoeducation, VR technology, and use safety behaviours. ... Sexual Dysfunction, Physiological.

2.

webapps.cihr-irsc.gc.ca

webapps.cihr-irsc.gc.ca/decisions/p/project_details.html?applId=478794&lang=en

Detailed information - Funding Decisions Database - CIHR

Virtual Reality Exposure for Vaginismus: A Replicated Single-Case Design ... Disorder; Pelvic Floor; Sexual Dysfunction; Vaginismus; Virtual Reality ...

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ctv.veeva.com

ctv.veeva.com/study/virtual-reality-exposure-for-vaginismus-a-replicated-single-case-design

Virtual Reality Exposure for Vaginismus: A Replicated Single ...

Vaginismus is a sexual dysfunction characterized by involuntary tightening of the pelvic floor muscles, preventing vaginal intercourse.

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pubmed.ncbi.nlm.nih.gov

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Virtual reality exposure therapy for sexual aversion: a proof ...

Virtual reality (VR) offers innovative treatment options for both mental and sexual disorders, such as female orgasmic disorder and erectile ...

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Advancing virtual reality interventions for sexuality and ...

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trialx.com

trialx.com/clinical-trials/listings/308328/virtual-reality-exposure-for-vaginismus-a-replicated-single-case-design/

Virtual Reality Exposure for Vaginismus: A Replicated Single- ...

VR is a new, powerful technology that, if effective, can directly improve clinical care offered to those suffering from vaginismus across Canada. This study ...

7.

tandfonline.com

tandfonline.com/doi/full/10.1080/0092623X.2023.2265924

Exploring Women's State-Level Anxiety in Response to ...

We examined erotica features that elicited anxiety and sexual presence in women. Thirty-eight women viewed erotic videos from different modalities (2D, VR) and ...

8.

withpower.com

withpower.com/trial/virtual-reality-exposure-for-vaginismus-9cf9a

Virtual Reality Exposure for Vaginismus (VIVID 2 Trial)

The VIVID 2 medical study, being run by University of British Columbia, is evaluating whether Virtual Reality Exposure will have tolerable side effects ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11833432/

The Effectiveness of Virtual Reality Application for Women ...

This systematic review and meta-analysis examined the effects of using VR on pain, anxiety and satisfaction in women under episiotomy repair.