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

24 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

90

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Standart Care
Participants receive standard care only.
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.
Experimenteel: Standard Care + Immersive Visual Modulation (IVM)
Participants receive standard care plus immersive virtual reality.
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.
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.
Experimenteel: Standard Care + IVM + Ambient Music Therapy (AMT)
Participants receive standard care plus immersive virtual reality and ambient music therapy.
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.
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.
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of successful completion of transvaginal ultrasonography (TVUS)
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 juli 2026

Primaire voltooiing (Geschat)

1 juli 2027

Studie voltooiing (Geschat)

1 juli 2027

Studieregistratiedata

Eerst ingediend

22 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 juli 2026

Eerst geplaatst (Werkelijk)

29 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

24 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Due to the personal data protection laws in our country, I cannot share patient information or data.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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