- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07734454
Immersive Visual Modulation and Ambient Music Therapy During Transvaginal Ultrasonography in Women With Vaginismus
2026년 7월 24일 업데이트: 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.
연구 개요
상태
초대로 등록
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
90
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Kayseri, 터키 (Türkiye), 38030
- Kayseri Private Erciyes Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Rate of successful completion of transvaginal ultrasonography (TVUS)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 7월 16일
기본 완료 (추정된)
2027년 7월 1일
연구 완료 (추정된)
2027년 7월 1일
연구 등록 날짜
최초 제출
2026년 7월 22일
QC 기준을 충족하는 최초 제출
2026년 7월 24일
처음 게시됨 (실제)
2026년 7월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 24일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026/07-002
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Due to the personal data protection laws in our country, I cannot share patient information or data.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .