- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07653763
Effect of Virtual Reality During Femoral Sheath Removal
The Effect of Virtual Reality Glasses During Femoral Sheath Removal on Pain, Anxiety, and Vital Signs in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Controlled Trial
연구 개요
상세 설명
Percutaneous coronary intervention is a commonly used invasive procedure in the diagnosis and treatment of coronary artery disease. Femoral sheath removal performed after the procedure may cause pain, anxiety, and hemodynamic changes in patients. Non-pharmacological interventions are increasingly used to improve patient comfort and reduce procedure-related stress.
Virtual reality technology is considered an effective distraction method that may reduce pain perception and anxiety by directing patients' attention to immersive visual and auditory stimuli. Previous studies have demonstrated the positive effects of virtual reality applications during invasive and painful procedures.
This randomized controlled study aimed to investigate the effect of virtual reality glasses used during femoral sheath removal on pain, anxiety, and vital signs in patients undergoing percutaneous coronary intervention. Patients were randomly assigned to either the intervention group receiving virtual reality application during femoral sheath removal or the control group receiving standard care. Pain intensity, anxiety levels, and vital signs were evaluated before, during, and after the procedure.
The findings of this study may contribute to evidence-based nursing interventions aimed at improving patient comfort during femoral sheath removal procedures.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Hatay
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İskenderun, Hatay, 터키 (Türkiye)
- İskenderun Devlet Hastanesi
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged 18 years and older
- Patients undergoing percutaneous coronary intervention via femoral access
- Patients with only one femoral sheath catheter
- Patients who did not receive analgesic medication before sheath removal
- Patients without severe hemorrhage or major hematoma at the femoral sheath site
- Patients able to communicate in Turkish
- Patients without visual, hearing, or speech impairment
- Patients without mental impairment affecting communication
- Patients without psychiatric diagnosis and not using psychiatric medication
Exclusion Criteria:
Patients unwilling to participate or wishing to withdraw from the study at any stage
- Patients who removed the virtual reality glasses during the intervention
- Patients who experienced intolerance to virtual reality application (e.g., dizziness or nausea)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Virtual Reality Group
Participants received virtual reality glasses during femoral sheath removal
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Virtual reality glasses were used during femoral sheath removal.
|
|
다른: Control Group
Participants received routine care during femoral sheath removal
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Participants received routine care during femoral sheath removal
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Heart Rate
기간: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
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Heart rate was measured in beats per minute using routine monitoring.
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Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
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Blood Pressure
기간: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
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Systolic blood pressure and diastolic blood pressure were measured in mmHg using routine monitoring.
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Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
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|
Oxygen Saturation
기간: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
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Oxygen saturation was measured as percent saturation using pulse oximetry.
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Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
|
|
Body Temperature
기간: 5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
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Body temperature was assessed using routine vital sign monitoring.
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5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
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Pain Level
기간: 5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
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Pain level was assessed using the Numeric Rating Scale (NRS).
The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates severe pain.
Higher scores indicate greater pain severity.
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5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
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Anxiety Level
기간: Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal
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Anxiety level was assessed using the State Anxiety Inventory (STAI).
Higher scores indicate higher anxiety levels.
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Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HKU-2025/069
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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