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

July 24, 2026 updated by: Demet Mutlu

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of successful completion of transvaginal ultrasonography (TVUS)
Time Frame: Immediately after the TVUS procedure during the baseline study visit.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Demet Mutlu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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