Virtual Reality Exposure for Vaginismus: A Replicated Single-Case Design

NCT06923306 | Recruiting

• 1 other identifier: H24-01258
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Vaginismus is a sexual dysfunction characterized by involuntary tightening of the pelvic floor muscles, preventing vaginal intercourse. It is defined by an intense fear of vaginal penetration, leading to persistent difficulties with vaginal intercourse and gynaecological exams. Psychological factors play a significant role in vaginismus. If the pelvic floor muscle tightening represents a defensive reflex, then treatment using a gradual exposure to feared stimuli using virtual reality may lead to an extinction of the phobic response, and to amelioration of vaginismus. If effective, the use of virtual reality technology can directly improve clinical care offered to those suffering from vaginismus.

Conditions

Vaginismus

Keywords

virtual reality; digital health; sexual health

Outcome Measures

Primary Outcomes (1)

• Ease of vaginal insertion

  Ease of vaginal insertion will be measured using a modified version of the Tampon Test used extensively in Provoked Vestibulodynia research.It involves having the participant insert a small vaginal accommodator (approximately the size of a tampon) into their vagina, and rate the ease of insertion on an 11-point scale ranging from 0 (unable to insert - too difficult) to 10 (can insert with great ease).

  Assessed 2x per week during no treatment (Phase A) and Treatment (VRE - Phase B), and once at 3-weeks and 3-month follow-ups.

Secondary Outcomes (5)

• Insertion pain

  Assessed 2x per week during no treatment (Phase A) and Treatment (VRE - Phase B), and once at 3-weeks and 3-month follow-ups.

• Frequency of sexual activity that includes vaginal insertion

  Assessed the day before Treatment (VRE - Phase B), final day of Treatment (VRE - Phase B), and once at 3-weeks and 3-month follow-ups.

• Frequency of vaginal accommodator/dilator use

  Assessed day before Treatment (VRE - Phase B), final day of Treatment (VRE - Phase B), and once at 3-weeks and 3-month follow-ups.

• Negative and catastrophic penetration-related cognitions (VPCQ)

  Assessed day before Treatment (VRE - Phase B), final day of Treatment (VRE - Phase B), and once at 3-weeks and 3-month follow-ups.

• Sexual distress (FSDS-R)

  Assessed day before Treatment (VRE - Phase B), final day of Treatment (VRE - Phase B), and once at 3-weeks and 3-month follow-ups.

Study Arms (1)

Virtual reality exposure plus psychoeducation

EXPERIMENTAL

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.

Behavioral: Virtual reality exposure

Interventions

Virtual reality exposure BEHAVIORAL

This is a single case design and there is only one intervention. In the no-treatment arm, participants will only have assessment but no virtual reality exposure therapy.

Virtual reality exposure plus psychoeducation

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

UBC Sexual Health Lab, Vancouver Hospital

Vancouver, British Columbia, V5M 1M9, Canada

RECRUITING

Diamond Health Care Centre

Vancouver, British Columbia, V5Z1M9, Canada

RECRUITING

Related Publications (3)

• Milani S, Jabs F, Brown NB, Zdaniuk B, Kingstone A, Brotto LA. Virtual Reality Erotica: Exploring General Presence, Sexual Presence, Sexual Arousal, and Sexual Desire in Women. Arch Sex Behav. 2022 Jan;51(1):565-576. doi: 10.1007/s10508-021-02111-8. Epub 2021 Oct 25.

  PMID: 34697691 BACKGROUND

• Wechsler TF, Kumpers F, Muhlberger A. Inferiority or Even Superiority of Virtual Reality Exposure Therapy in Phobias?-A Systematic Review and Quantitative Meta-Analysis on Randomized Controlled Trials Specifically Comparing the Efficacy of Virtual Reality Exposure to Gold Standard in vivo Exposure in Agoraphobia, Specific Phobia, and Social Phobia. Front Psychol. 2019 Sep 10;10:1758. doi: 10.3389/fpsyg.2019.01758. eCollection 2019.

  PMID: 31551840 BACKGROUND

• Ter Kuile MM, Melles R, de Groot HE, Tuijnman-Raasveld CC, van Lankveld JJDM. Therapist-aided exposure for women with lifelong vaginismus: a randomized waiting-list control trial of efficacy. J Consult Clin Psychol. 2013 Dec;81(6):1127-1136. doi: 10.1037/a0034292. Epub 2013 Sep 23.

  PMID: 24060195 BACKGROUND

MeSH Terms

Conditions

Vaginismus

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lori Brotto, PhD, RPsych

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Selden

CONTACT

6048754111; lselden@student.ubc.ca

Kelsey Lynch, MA

CONTACT

6048754111; kelsey.lynch@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study uses a multiple baseline single case design (SCD) in which the investigators will compare no treatment with VRE using a non-concurrent randomized single case A-B phase design, with 4 cohorts of 5 participants (n=20). To establish an experimental effect in SCD, ongoing assessment of outcomes throughout each phase is a necessary condition, with best-practice guidelines mandating at least 3 observations per outcome variable per phase. Here, for each participant, primary and secondary outcomes will be assessed repeatedly during baseline (i.e., Baseline and Psychoeducation - Phase A, lasting 1.5 - 3.5 weeks, and during Virtual Reality Exposure therapy - Phase B), lasting 3 weeks.

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 11, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: The data will be made available within 3 months after publication.
• Access Criteria: The data will be freely available on the OSF website so no need for requests.

Locations

CA (2)