The Effect of an Eye Mask-Based Blackout Protocol on Patients' Sleep Quality and Melatonin Levels: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sleep quality (Richard-Campbell Sleep Questionnaire [RCSQ] total score)
研究概览
简要总结
Sleep disturbance is a common problem among patients hospitalized in intensive care units due to continuous light exposure, noise, and frequent medical interventions. Disruption of the normal day-night cycle may reduce melatonin secretion and negatively affect sleep quality and recovery.
This randomized controlled study aimed to evaluate the effect of an eye mask-based blackout protocol on sleep quality and melatonin levels in patients hospitalized in a chest intensive care unit. Participants were randomly assigned to either an intervention group or a control group. Patients in the intervention group wore a lightproof eye mask during nighttime hours (11:00 p.m. to 05:00 a.m.) in addition to standard light-reduction practices, while the control group received routine intensive care.
Sleep quality was assessed using validated subjective scales, and melatonin levels were evaluated by measuring urinary 6-sulfatoxymelatonin. The study sought to determine whether reducing nighttime light exposure using a simple, non-invasive intervention could improve sleep quality and support circadian rhythm regulation in intensive care patients.
详细描述
This study was designed as a randomized controlled trial to investigate the effect of an eye mask-based blackout protocol on sleep quality and melatonin levels in patients hospitalized in a chest intensive care unit.
The study was conducted at a university research hospital in Turkey. Eligible adult patients who were conscious, breathing spontaneously, and able to provide informed consent were randomly assigned to either an intervention group or a control group using a 1:1 allocation ratio. Patients receiving mechanical ventilation or using medications affecting melatonin secretion were excluded.
Participants in the intervention group wore a lightproof eye mask between 11:00 p.m. and 05:00 a.m. for two consecutive nights. In addition to eye mask use, nighttime lighting in the patient's room was minimized according to a standardized protocol. The control group received routine intensive care without any additional light-reduction intervention.
Sleep quality was evaluated using the Visual Analogue Scale for Sleep Quality and the Richard Campbell Sleep Scale. Melatonin secretion was assessed by measuring urinary 6-sulfatoxymelatonin levels collected overnight. Urine samples were stored under controlled conditions and analyzed using an enzyme-linked immunosorbent assay (ELISA).
The primary objective of the study was to determine whether the eye mask-based blackout protocol improved subjective sleep quality. A secondary objective was to assess changes in melatonin levels as a biological marker of circadian rhythm regulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Laboratory personnel analysing urinary melatonin levels and the statistician performing data analysis were blinded to group allocation. Due to the nature of the intervention, participants and bedside nurses could not be blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years and older
- •Patients admitted to the intensive care unit
- •Patients expected to remain in the intensive care unit for at least 24 hours
- •Patients with the ability to tolerate an eye mask during nighttime sleep
- •Patients or their legal representatives who provided informed consent
排除标准
- •Patients with facial trauma, eye injury, or ophthalmologic conditions preventing eye mask use
- •Patients receiving continuous deep sedation
- •Patients with severe cognitive impairment or delirium preventing cooperation
- •Patients with diagnosed sleep disorders prior to intensive care admission
- •Patients who refused to participate in the study
研究组 & 干预措施
Eye Mask Intervention Group
Participants received a nighttime eye mask-based blackout protocol during sleep hours in the intensive care unit in addition to routine care.
干预措施: Eye Mask-Based Blackout Protocol (Other)
Control Group
Participants received routine intensive care without the use of an eye mask.
结局指标
主要结局
Sleep quality (Richard-Campbell Sleep Questionnaire [RCSQ] total score)
时间窗: Measured twice: (1) baseline-morning of ICU day 2 (after the first night, 23:00-05:00), and (2) post-intervention-morning of ICU day 3 (after the blackout night with eye mask from 23:00 to 05:00).
Change in sleep quality assessed using the Richard-Campbell Sleep Questionnaire (6 items, 0-100 VAS each; higher scores indicate better sleep). The total score is calculated as the mean of all item scores.
次要结局
- Sleep quality (Visual Analogue Scale [VAS], 1-10)(Measured twice: (1) baseline-morning of ICU day 2 (after the first night, 23:00-05:00), and (2) post-intervention-morning of ICU day 3 (after the blackout night with eye mask from 23:00 to 05:00).)
- Urinary 6-sulfatoxymelatonin (aMT6s) level (ng/mg creatinine)(Measured twice using overnight urine collection: (1) baseline-urine accumulated from 23:00 to 05:00 on the first night (ICU day 2 morning sample), and (2) post-intervention-urine accumulated from 23:00 to 05:00 on the blackout night with eye mask (ICU da)
研究者
Bahar Ciftci
Principal Investigator
Ataturk University