- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07734454
Immersive Visual Modulation and Ambient Music Therapy During Transvaginal Ultrasonography in Women With Vaginismus
24 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Iscrizione su invito
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
90
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Kayseri, Turchia (Türkiye), 38030
- Kayseri Private Erciyes Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Standart Care
Participants receive standard care only.
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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.
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Sperimentale: Standard Care + Immersive Visual Modulation (IVM)
Participants receive standard care plus immersive virtual reality.
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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.
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Sperimentale: Standard Care + IVM + Ambient Music Therapy (AMT)
Participants receive standard care plus immersive virtual reality and ambient music therapy.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Rate of successful completion of transvaginal ultrasonography (TVUS)
Lasso di tempo: Immediately after the TVUS procedure during the baseline study visit.
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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.
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Immediately after the TVUS procedure during the baseline study visit.
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
16 luglio 2026
Completamento primario (Stimato)
1 luglio 2027
Completamento dello studio (Stimato)
1 luglio 2027
Date di iscrizione allo studio
Primo inviato
22 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
24 luglio 2026
Primo Inserito (Effettivo)
29 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Disordini mentali
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie genitali, femmina
- Disfunzione sessuale, fisiologica
- Disfunzioni sessuali, psicologiche
- Malattie vaginali
- Vaginismo
- Amministrazione dei servizi sanitari
- Qualità, accesso e valutazione dell'assistenza sanitaria
- Qualità dell'assistenza sanitaria
- Indicatori di qualità, assistenza sanitaria
- Standard di cura
Altri numeri di identificazione dello studio
- 2026/07-002
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
Due to the personal data protection laws in our country, I cannot share patient information or data.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .