Virtual Reality Exposure for Vaginismus: A Replicated Single-Case Design
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Ease of vaginal insertion
研究概览
简要总结
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.
详细描述
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. We also predict a decrease in both secondary outcomes of vaginal penetration related cognitions, and female sexual distress.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Virtual reality exposure plus psychoeducation
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.
干预措施: Virtual reality exposure (Behavioral)
结局指标
主要结局
Ease of vaginal insertion
时间窗: Assessed 2x per week during no treatment (Phase A) and Treatment (VRE - Phase B), and once at 3-weeks and 3-month follow-ups.
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).
次要结局
- 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.)
研究者
Lori Brotto
Professor
University of British Columbia