Immersive Visual Modulation and Ambient Music Therapy During Transvaginal Ultrasonography in Women With Vaginismus
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
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Kayseri, Tyrkiet (Türkiye), 38030
- Kayseri Private Erciyes Hospital
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / 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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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Psykiske lidelser
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Kønssygdomme, kvindelige
- Seksuel dysfunktion, Fysiologisk
- Seksuelle dysfunktioner, psykologiske
- Vaginale sygdomme
- Vaginisme
- Sundhedstjenester Administration
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Sundhedskvalitet
- Kvalitetsindikatorer, sundhedsvæsenet
- Standard for pleje
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 2026/07-002
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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