Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
NCT ID:
NCT06923306
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT06923306
Study Brief:
Protocol Section:
NCT06923306