Immersive Visual Modulation and Ambient Music Therapy During Transvaginal Ultrasonography in Women With Vaginismus

NCT07734454 | Enrolling By Invitation

• 1 other identifier: 2026/07-002
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaginismus

Keywords

vaginismus; transvaginal ultrasonography; immersive visual modulation; ambient music therapy

Outcome Measures

Primary Outcomes (1)

• Rate of successful completion of transvaginal ultrasonography (TVUS)

  The primary outcome is the rate of successful completion of the TVUS procedure. Successful completion is defined as complete insertion of the transvaginal ultrasound probe and completion of the examination without interruption due to pain, anxiety, fear, or involuntary pelvic floor muscle contraction. Results will be reported as the percentage of participants with successful TVUS completion in each intervention group.

  Immediately after the TVUS procedure during the baseline study visit.

Study Arms (3)

Standart Care

ACTIVE COMPARATOR

Participants receive standard care only.

Behavioral: Standard Care

Standard Care + Immersive Visual Modulation (IVM)

EXPERIMENTAL

Participants receive standard care plus immersive virtual reality.

Behavioral: Standard Care; Device: Immersive Visual Modulation (IVM)

Standard Care + IVM + Ambient Music Therapy (AMT)

EXPERIMENTAL

Participants receive standard care plus immersive virtual reality and ambient music therapy.

Behavioral: Standard Care; Device: Immersive Visual Modulation (IVM); Behavioral: Ambient Music Therapy (AMT)

Interventions

Standard Care BEHAVIORAL

Participants receive standard care for vaginismus that had been provided before enrollment. No virtual reality or music intervention is administered during the transvaginal ultrasonography procedure.

Standard Care + IVM + Ambient Music Therapy (AMT); Standard Care + Immersive Visual Modulation (IVM); Standart Care

Immersive Visual Modulation (IVM) DEVICE

Immersive Visual Modulation (IVM) is delivered using a virtual reality headset. Participants view standardized relaxing nature scenes beginning 15 minutes before transvaginal ultrasonography and continuing until the procedure is completed.

Standard Care + IVM + Ambient Music Therapy (AMT); Standard Care + Immersive Visual Modulation (IVM)

Ambient Music Therapy (AMT) BEHAVIORAL

Participants listen to standardized instrumental ambient music with natural environmental sounds through over-ear headphones beginning 15 minutes before transvaginal ultrasonography and continuing until the procedure is completed.

Standard Care + IVM + Ambient Music Therapy (AMT)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Demet Mutlu: lead

Study Sites (1)

Kayseri Private Erciyes Hospital

Kayseri, 38030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vaginismus

Interventions

Standard of Care

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)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 29, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)