The Effect of Pink-Brown Noise and the Quiet Time Intervention on Sleep Parameters in Intensive Care Unit Patients: A Single-Center, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Sleep Efficiency
研究概览
简要总结
Sleep disruption is common in adult intensive care unit (ICU) patients and is often worsened by environmental noise and nighttime care activities. Poor sleep may negatively affect recovery and well-being.
This single-center, three-arm randomized controlled trial will evaluate the short-term effects of two non-pharmacological interventions-(1) pink-brown noise masking and (2) a quiet time intervention-on objective sleep parameters in adult ICU patients, compared with standard care.
Sleep outcomes will be measured using actigraphy-based wearable monitoring, including total sleep time, sleep efficiency, sleep onset latency, wake after sleep onset, and number of awakenings. Results are expected to support evidence-based nursing approaches to improve sleep in ICU patients.
详细描述
This study is designed as a single-center, three-arm, parallel-group randomized controlled clinical trial to evaluate the short-term effects of environmental acoustic masking and a quiet night intervention on objective sleep parameters in adult intensive care unit (ICU) patients.
Sleep disturbance is highly prevalent among critically ill patients due to environmental factors such as excessive noise, continuous light exposure, frequent nursing interventions, alarm sounds, mechanical ventilation, pain, anxiety, and disease-related physiological stress. These factors lead to fragmented and superficial sleep, disruption of the sleep-wake cycle, and are associated with adverse clinical outcomes including delirium, immune dysfunction, hemodynamic instability, prolonged ICU stay, and increased morbidity.
The study includes three groups:
- an acoustic masking intervention group,
- a quiet night intervention group, and
- a standard care control group.
The acoustic masking group will receive low-frequency, nature-based sound exposure prior to sleep onset, followed by earplug use throughout the night. The quiet night group will receive environmental noise and light reduction measures supported by earplugs and an eye mask. The control group will receive standard ICU care without additional sleep-promoting interventions.
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 and data analysts are blinded to group allocation. Participants and care providers are not blinded due to the nature of the interventions.
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
- •Inclusion Criteria:
- •Adults aged 18 years and older
- •Patients admitted to the adult intensive care unit
- •Expected ICU stay of at least one night
- •Ability to tolerate non-invasive sleep-related interventions (earplugs, eye mask, or acoustic masking)
- •Informed consent obtained from the patient or legally authorized representative
排除标准
- •Exclusion Criteria:
- •Severe hearing impairment preventing use of acoustic interventions
- •Severe cognitive impairment or coma preventing sleep assessment
- •Use of continuous deep sedation
- •Diagnosed sleep disorders requiring pharmacological treatment
- •Skin conditions preventing use of wrist-worn actigraphy
研究组 & 干预措施
Acoustic Noise Masking Group
Patients receiving environmental acoustic noise masking before and during nighttime sleep.
干预措施: Acoustic Noise Masking Intervention (Behavioral)
Quiet Night Intervention Group
Patients receiving a quiet night protocol including environmental noise and light reduction supported by earplugs and eye mask.
干预措施: Quiet Night Intervention (Behavioral)
Standard Care Control Group
Patients receiving routine intensive care without additional sleep-promoting interventions.
结局指标
主要结局
Sleep Efficiency
时间窗: Single night (23:00-06:00)
Sleep efficiency will be measured using a single wrist-worn actigraphy device (smartwatch) during nighttime sleep (23:00-06:00).
次要结局
- Total Sleep Time(Single night (23:00-06:00))
- Sleep Onset Latency(Single night (23:00-06:00))
- Wake After Sleep Onset(Single night (23:00-06:00))
- Number of Nocturnal Awakenings(Single night (23:00-06:00))
研究者
Saadet Can Çiçek
Associate Professor
Abant Izzet Baysal University