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

21 september 2026 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

90

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år till 40 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.

Experimentell: 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.

Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Rate of successful completion of transvaginal ultrasonography (TVUS)
Tidsram: 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.

Samarbetspartners och utredare

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Sponsor

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 juli 2026

Primärt slutförande (Beräknad)

1 juli 2027

Avslutad studie (Beräknad)

1 juli 2027

Studieregistreringsdatum

Först inskickad

22 juli 2026

Först inskickad som uppfyllde QC-kriterierna

24 juli 2026

Första postat (Faktisk)

29 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 september 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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