Clinical trial NCT06923306: Virtual Reality Exposure for Vaginismus: A Replicated Single-Case Design
Official title: Virtual Reality Exposure for Vaginismus: A Replicated Single-Case Design
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vaginismus
Keywords: virtual reality
digital health
sexual health
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2025-04-11
Enrollment: 20
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Purpose/Aims:

VR is a new, powerful technology that, if effective, can directly improve clinical care offered to those suffering from vaginismus across Canada. This study will advance health-related knowledge by providing new data on the efficacy of VRE for vaginismus and health outcomes by having the potential to increase access to effective treatment for women living in rural and remote areas as well as those who experience other barriers in accessing care-including extreme fear or anxiety. Thus, this research program has a high likelihood of filling a major gap in healthcare for women and others with a vagina and, if effective, our treatment paradigm has significant potential for scale-up.

Hypothesis:

The investigators will use the Marascuilo-Busk randomization test to test our hypothesis that the onset of VRE leads to an increase in vaginal insertion ease, a decrease in insertion pain, and an increase in the frequency of sexual activity that includes penetration.

Justification:

Lack of Effective Treatments: Available psychological treatments for vaginismus involve self-insertion of vaginal accommodators (which resemble dildos) at home by progressively inserting larger sizes as the individual practices relaxation exercises that address both the psychological fear and the involuntary pelvic floor muscle tension. However, individuals with vaginismus experience significant and longstanding avoidance and struggle to complete accommodator exercises on their own at home, even if they believe the treatment will be effective. This avoidance significantly limits treatment effectiveness. For example, the largest RCT (n=117) evaluating the efficacy of cognitive behavioural therapy for vaginismus, which included gradual self-insertion of accommodators into the vagina, yielded a small treatment effect: only 14% of women who attended ten 2-hour group therapy sessions were able to have vaginal intercourse at post-treatment.

Exposure - An Essential Treatment Element: Therapist-guided exposure therapy includes a patient progressively inserting vaginal accomodators in the presence of a supportive clinician, and is highly effective in treating vaginismus, showing greater success than solo, self-guided interventions. Of 77 women who attended two therapist-guided sessions over one week, 89% reported vaginal intercourse 6-weeks post-treatment. Despite this effective treatment approach, in North America therapist-aided exposure practices are not permitted due to institutional restrictions, licensing regulations, and/or patient discomfort. As such, the development of alternative exposure-based treatments is needed. The investigators propose an innovative application of VR, as an alternative to exposure, to address this significant health gap.

VR Exposure - An Opportunity: VRE immerses individuals in 3D simulations of feared situations and is as effective as real-life exposure for specific phobias. VRE for vaginismus, which involves gradual exposure to feared (virtual) sexual encounters, may diminish phobic responses towards vaginal penetration. Given that women with vaginismus cope via longstanding avoidance, and often do not perform at-home exposure exercises included in frontline recommended treatments, the "immersive" nature of VRE can directly target this avoidance.

Proof of Concept: In 2022, the investigators conducted a proof-of-concept study in which they assessed the acceptability and feasibility of VRE for vaginismus. Our results indicated that patients with vaginismus experienced greater distress when viewing VR erotica and were more likely to use anxiety management strategies than controls. Despite this, 95% of participants with vaginismus endorsed VRE as an acceptable treatment option.

Theoretical Approach/Framework Fear in the Context of Genital Pain: Fear of pain elicits a cascade of cognitive-motivational and physio¬logical processes that interact with one another and influence pain processing via multiple pathways. Specifically, fear induces hypervigilance to (potentially) pain-inducing sexual stimuli, their appraisal as threatening, and draws attention away from sexually exciting cues. Negative appraisals of sexual stimuli paired with reduced attention to sexual cues inhibits genital arousal, which increases pelvic floor muscle tension and vaginal dryness. These physical changes cause mechanical friction, and in turn, pain. The association between pain and sexual activity leads to avoidance of sexual encounters. Therefore, tackling fear is a key piece of the genital pain puzzle.

Fear Learning as a Treatment Target: Research suggests that fear of genital pain is learned through classical conditioning when a neutral stimulus is paired with pain. For example, if an adolescent inserts a tampon for the first time and there is significant pain, they will learn to expect pain on subsequent insertions. As a result, they may avoid using tampons, which they think will prevent pain and/or reduce fear, reinforcing the avoidance behaviour. Their behavioural response maintains the tampon's threat value, as the absence of the painful outcome is attributed to the avoidance. In the case of vaginismus, fear generalization occurs, such that the adolescent's expectation of pain and consequent fear spreads to any type of stimulus that involves vulvar and/or vaginal touch, such as vaginal inter¬course and gynaecological exams, giving rise to a broader penetration-pain association that extends from tampons to all insertive objects.

Since fear acquisition and (especially) fear generalization play key roles in the development and maintenance of chronic genital pain, effective treatments require fear extinction via conditioning, commonly referred to as exposure therapy. Traditionally, this involves repeatedly exposing an individual to the fear-inducing stimulus until their fear decreases (habituates), which represents a corrective experience. However, recent work from experts in the study of anxiety disorders suggests that expectancy violation and inhibitory learning are the key mechanisms of exposure, with more robust treatment effects when there is a discrepancy between expected and actual outcomes. When exposure is successful, extinction does not erase the original penetration-pain association that was learned during acquisition, but a new inhibitory penetration-no pain association develops and inhibits the retrieval of the original acquisition memory.

The protocol proposed here will incorporate psychoeducation about these concepts before VRE treatment begins, repeated exposure to virtual sexual scenarios, and progressive insertion of vaginal accommodators for sensory-motor feedback training. Psychoeducation is an evidence-based intervention that provides information and support to individuals. It has been found to be beneficial when coupled with other treatments, and may be particularly important for e-health interventions. VRE treatment studies for anxiety disorders often include patient psychoeducation, VR technology, and use safety behaviours. Psychoeducational interventions for vaginismus have also proved beneficial for fear behaviours and overall well-being. Communication exercises, relaxation techniques, and sex education are common elements of these programs. The investigators predict that these treatment elements will promote the extinction of penetration-related fears for individuals with vaginismus.

Eligibility criteria: 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.

Exclusion Criteria:

Presence of: unprovoked vaginal pain; a vulvar skin condition (i.e., lichen sclerosus); an imperforate hymen; or 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.

Primary outcomes:
measure: Ease of vaginal insertion
timeFrame: 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:
measure: Insertion pain
timeFrame: Assessed 2x per week during no treatment (Phase A) and Treatment (VRE - Phase B), and once at 3-weeks and 3-month follow-ups.
measure: Frequency of sexual activity that includes vaginal insertion
timeFrame: 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.
measure: Frequency of vaginal accommodator/dilator use
timeFrame: Assessed day before Treatment (VRE - Phase B), final day of Treatment (VRE - Phase B), and once at 3-weeks and 3-month follow-ups.
measure: Negative and catastrophic penetration-related cognitions (VPCQ)
timeFrame: Assessed day before Treatment (VRE - Phase B), final day of Treatment (VRE - Phase B), and once at 3-weeks and 3-month follow-ups.
measure: Sexual distress (FSDS-R)
timeFrame: Assessed day before Treatment (VRE - Phase B), final day of Treatment (VRE - Phase B), and once at 3-weeks and 3-month follow-ups.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Diamond Health Care Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Lori Brotto, PhD, RPsych
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.