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

Effects of Immersive Visual Modulation (IVM) and/or Ambient Music Therapy (AMT) During Transvaginal Ultrasonography on Procedural Success, Pain, Anxiety, and Patient Satisfaction in Women With Vaginismus Who Failed to Achieve Vaginal Intercourse Despite Standard Care: A Randomized Controlled Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Vaginismus
• Intervention / Treatment: Behavioral: Standard Care; Device: Immersive Visual Modulation (IVM); Behavioral: Ambient Music Therapy (AMT)

Detailed Description

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. Virtual reality (VR) technology has been used in many areas of healthcare in recent years for diagnostic, therapeutic, and rehabilitative purposes. In particular, VR applications have been shown to be effectively used in ophthalmology for visual rehabilitation, surgical training, amblyopia treatment, and patient adaptation processes. The clinical use of VR-based applications in amblyopia treatment and their inclusion in health insurance coverage supports the clinical applicability of this technology. VR technology is reported to have positive effects on attention redirection, relaxation, and anxiety reduction by creating controlled visual stimuli. The use of VR in gynecological procedures, pelvic examinations, and other invasive procedures has been shown to reduce pain and anxiety levels. Furthermore, VR applications have been reported to increase patient comfort and improve procedure tolerance in invasive urological procedures such as cystoscopy. In cases of vaginismus, where psychological components play a significant role, it is thought that virtual reality technology can reduce fear and avoidance behaviors by providing a safe and controlled environment. It is predicted that relaxing nature images, distracting visual content, and immersive experiences can contribute to the treatment process by reducing anxiety levels. The initiation of clinical trials evaluating the use of VR in vaginismus treatment in recent years shows that this approach is gaining increasing attention. Music therapy, on the other hand, is a non-pharmacological supportive method that has been shown to have positive effects on anxiety control, pain management, and emotional regulation. Studies in the literature report that the combined use of VR and music therapy can reduce symptoms in chronic pain, anxiety disorders, and stress-related conditions. This effect is thought to be related to autonomic nervous system regulation, multisensory integration, attention modulation, and emotional relaxation mechanisms. This study aims to evaluate the effects of VR applications added to the standard approach in vaginismus treatment, and music therapy combined with VR, on treatment success, pain level, anxiety level, and patient satisfaction.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kayseri, Turkey (Türkiye), 38030
    • Kayseri Private Erciyes Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standart Care; Participants receive standard care only.	Behavioral: Standard Care; 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.
Experimental: Standard Care + Immersive Visual Modulation (IVM); Participants receive standard care plus immersive virtual reality.	Behavioral: Standard Care; 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.; Device: Immersive Visual Modulation (IVM); 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.
Experimental: Standard Care + IVM + Ambient Music Therapy (AMT); Participants receive standard care plus immersive virtual reality and ambient music therapy.	Behavioral: Standard Care; 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.; Device: Immersive Visual Modulation (IVM); 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.; Behavioral: Ambient Music Therapy (AMT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Demet Mutlu

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: July 22, 2026
• First Submitted That Met QC Criteria: July 24, 2026
• First Posted (Actual): July 29, 2026

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 24, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: vaginismus; transvaginal ultrasonography; immersive visual modulation; ambient music therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Vaginal Diseases; Vaginismus; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2026/07-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the personal data protection laws in our country, I cannot share patient information or data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No