Effect of ASMR and White Noise on Sleep Quality in Patients Undergoing Elective Lower Extremity Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative Sleep Quality
研究概览
简要总结
This randomized controlled trial aims to evaluate the effects of Autonomous Sensory Meridian Response (ASMR) and white noise on postoperative sleep quality in patients undergoing elective lower extremity surgery. Postoperative sleep disturbances are common after orthopedic surgery and may negatively affect pain perception, recovery, and overall patient outcomes. Participants will be randomly assigned to one of three groups: ASMR intervention, white noise intervention, or control group. Patients in the intervention groups will listen to standardized 30-minute audio recordings before sleep during the postoperative period, while the control group will receive routine care with headphones only. Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ). The study aims to determine which non-pharmacological intervention is more effective in improving postoperative sleep quality.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors were blinded to group allocation during data analysis and outcome evaluation.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ASMR Group
Participants will listen to standardized 30-minute ASMR audio recordings before sleep during the postoperative hospitalization period.
干预措施: ASMR Audio Intervention (Behavioral)
White Noise Group
Participants will listen to standardized 30-minute white noise audio recordings before sleep during the postoperative hospitalization period.
干预措施: White Noise Audio Intervention (Behavioral)
Control Group
Participants will receive routine postoperative care and will wear headphones without audio playback before sleep.
结局指标
主要结局
Postoperative Sleep Quality
时间窗: Postoperative nights 1 and 2
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.
次要结局
未报告次要终点
研究者
muzeyyen ataseven
PhD, RN, Assistant Professor
Istanbul Medipol University Hospital
