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Enrolling By Invitation
NCT07734454
Immersive Visual Modulation and Ambient Music Therapy During Transvaginal Ultrasonography in Women With Vaginismus
Conditions: Vaginismus
Sex: Female
Ages: 20 Years – 40 Years
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Demet Mutlu
Location: Kayseri Private Erciyes Hospital Kayseri
Summary
Vaginismus is a sexual dysfunction characterized by involuntary contractions of the pelvic floor muscles that prevent vaginal penetration. This condition is often associated with intense fear, anxiety, and avoidance behaviors. Vaginismus can negatively impact not only sexual life but also gynecological examination processes, psychosocial well-being, and quality of life. In cases of vaginismus, where psychological components play a significant role, it is believed that virtual reality technology can reduce fear and avoidance behaviors by providing a safe and controlled environment. In particular, relaxing nature images and distracting visual content are expected to contribute to the treatment process by reducing anxiety levels. This study aims to evaluate the effects of virtual reality applications added to the standard approach in vaginismus treatment, and music therapy combined with virtual reality, on treatment success, pain level, anxiety level, and patient satisfaction.
Eligibility Criteria
Inclusion Criteria:
* Female participants aged 20-40 years.
* Diagnosis of Genito-Pelvic Pain/Penetration Disorder (GPPPD; vaginismus) according to DSM-5 criteria.
* Failure to achieve vaginal intercourse despite previous standard care for vaginismus.
* Previously evaluated by a gynecologist and/or a psychiatrist, clinical psychologist, or certified sexual therapist.
* Scheduled to undergo transvaginal ultrasonography.
* Able to understand the study procedures and provide written informed consent.
Exclusion Criteria:
* Active psychiatric disorder that may interfere with study participation.
* Current pregnancy or previous childbirth.
* Visual or hearing impairment preventing the use of the virtual reality device or ambient music intervention.
* Pelvic anatomical abnormalities preventing transvaginal ultrasonography.
* Concurrent participation in another interventional study for vaginismus.
* Inability or unwillingness to provide written informed consent.
Source: ClinicalTrials.gov (NCT07734454). StuddyBuddy aggregates publicly available trial information.