Clinical Trial

Effect of an Eye Mask-Based Blackout Protocol on Sleep Quality and Melatonin

Completed
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Summary
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.
Trial Details
NCT Number NCT07385768
Lead Sponsor Ataturk University
Conditions Sleep Disturbance, Circadian Rhythm Sleep Disorders, Intensive Care Unit Patients
Enrollment 60 participants
Start Date 2024-08-01
Primary Completion 2025-05-01 (estimated)
Study Completion 2025-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-04