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
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Müzeyyen Ataseven, PhD, RN
- 电话号码:+905052299474
- 邮箱:muzeyyenataseven@hotmail.com
学习地点
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Istanbul、土耳其(türkiye)、34810
- Fatih Sultan Mehmet Training and Research Hospital
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接触:
- Müzeyyen Ataseven, PhD, RN
- 电话号码:+905052299474
- 邮箱:muzeyyenataseven@hotmail.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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.
其他名称:
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实验性的: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.
其他名称:
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无干预:Control Group
Participants will receive routine postoperative care and will wear headphones without audio playback before sleep.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative Sleep Quality
大体时间: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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合作者和调查者
调查人员
- 首席研究员:Müzeyyen Ataseven, PhD,RN、Medipol University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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