Effect of ASMR and White Noise on Sleep Quality in Patients Undergoing Elective Lower Extremity Surgery (SLEEP-ASMR)
Effect of ASMR and White Noise on Sleep Quality in Patients Undergoing Elective Lower Extremity Surgery: A Randomized Controlled Trial
연구 개요
상태
상세 설명
Sleep disturbance is one of the most common postoperative complications following orthopedic surgery and is associated with increased pain perception, delayed recovery, prolonged hospitalization, and decreased patient comfort. Non-pharmacological interventions that improve sleep quality may contribute positively to postoperative recovery and patient outcomes.
Autonomous Sensory Meridian Response (ASMR) is characterized by relaxing sensory experiences triggered by auditory stimuli and has recently gained attention for its potential effects on sleep and emotional well-being. White noise is another auditory intervention commonly used to reduce environmental noise perception and promote sleep quality. Although previous studies have demonstrated beneficial effects of ASMR and white noise separately, there is limited evidence comparing these interventions in postoperative orthopedic patients.
This study is designed as a three-arm parallel randomized controlled trial conducted in patients undergoing elective lower extremity surgery. Eligible participants will be randomized in a 1:1:1 ratio into ASMR, white noise, or control groups using computer-generated block randomization. Participants in the intervention groups will listen to standardized 30-minute audio recordings before sleep during the postoperative hospitalization period. The control group will receive headphones without audio playback to minimize environmental noise exposure.
The primary outcome of the study is postoperative sleep quality measured using the Richards-Campbell Sleep Questionnaire (RCSQ). Secondary outcomes may include postoperative pain intensity, nocturnal awakening frequency, and patient comfort. Blinded researchers will perform outcome assessment and statistical analyses.
The findings of this study are expected to provide evidence regarding effective non-pharmacological nursing interventions to improve postoperative sleep quality in orthopedic surgery patients.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Müzeyyen Ataseven, PhD, RN
- 전화번호: +905052299474
- 이메일: muzeyyenataseven@hotmail.com
연구 장소
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Istanbul, 터키 (Türkiye), 34810
- Fatih Sultan Mehmet Training and Research Hospital
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연락하다:
- Müzeyyen Ataseven, PhD, RN
- 전화번호: +905052299474
- 이메일: muzeyyenataseven@hotmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18 years and older
- Undergoing elective lower extremity surgery
- Conscious and able to communicate
- No hearing impairment or hearing aid use
- Numeric Rating Scale (NRS) pain score of 5 or lower
- No use of medications affecting sleep
- Willing to participate in the study
- Able to provide written informed consent
Exclusion Criteria:
- Participation in another clinical study
- Surgery due to trauma
- Transfer to the intensive care unit during the postoperative period
- Development of serious postoperative complications
- Withdrawal from the study at any stage
- Failure to comply with study procedures
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: ASMR Group
Participants will listen to standardized 30-minute ASMR audio recordings before sleep during the postoperative hospitalization period.
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Standardized ASMR audio recordings administered for 30 minutes before sleep during the postoperative period.
다른 이름들:
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실험적: White Noise Group
Participants will listen to standardized 30-minute white noise audio recordings before sleep during the postoperative hospitalization period.
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Standardized white noise audio recordings administered for 30 minutes before sleep during the postoperative period.
다른 이름들:
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간섭 없음: Control Group
Participants will receive routine postoperative care and will wear headphones without audio playback before sleep.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Postoperative Sleep Quality
기간: Postoperative nights 1 and 2
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Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ).
The RCSQ is a validated five-item visual analog scale evaluating sleep depth, sleep latency, number of awakenings, sleep efficiency, and overall sleep quality.
Each item is scored between 0 and 100, and higher scores indicate better sleep quality.
Total scores are calculated by averaging the item scores.
Sleep quality will be evaluated during postoperative nights 1 and 2.
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Postoperative nights 1 and 2
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공동 작업자 및 조사자
수사관
- 수석 연구원: Müzeyyen Ataseven, PhD,RN, Medipol University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
- ASMR-2026
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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