The Effect of an Eye Mask-Based Blackout Protocol on Patients' Sleep Quality and Melatonin Levels: A Randomised Controlled Trial
Abstract
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.
Conditions: Sleep Disturbance, Circadian Rhythm Sleep Disorders, Intensive Care Unit Patients.
Primary outcome: Sleep quality (Richard-Campbell Sleep Questionnaire [RCSQ] total score).
Enrollment: 60 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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