- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07734454
Immersive Visual Modulation and Ambient Music Therapy During Transvaginal Ultrasonography in Women With Vaginismus
24. juli 2026 oppdatert 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.
Studieoversikt
Status
Påmelding etter invitasjon
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
90
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Kayseri, Tyrkia (Türkiye), 38030
- Kayseri Private Erciyes Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of successful completion of transvaginal ultrasonography (TVUS)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
16. juli 2026
Primær fullføring (Antatt)
1. juli 2027
Studiet fullført (Antatt)
1. juli 2027
Datoer for studieregistrering
Først innsendt
22. juli 2026
Først innsendt som oppfylte QC-kriteriene
24. juli 2026
Først lagt ut (Faktiske)
29. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Psykiske lidelser
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kjønnssykdommer, kvinner
- Seksuell dysfunksjon, fysiologisk
- Seksuelle dysfunksjoner, psykologiske
- Vaginale sykdommer
- Vaginisme
- Health Services Administration
- Helsevesenets kvalitet, tilgang og evaluering
- Kvalitet på helsehjelpen
- Kvalitetsindikatorer, helsehjelp
- Standard for omsorg
Andre studie-ID-numre
- 2026/07-002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Due to the personal data protection laws in our country, I cannot share patient information or data.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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