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NCT Number: NCT07385768

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

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.

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Key information

Conditions

Sleep Disturbance Chronobiology Disorders Circadian Rhythm Sleep Disorders Dyssomnias Intensive Care Unit Patients Mental Disorders Nervous System Diseases Occupational Diseases Parasomnias Sleep Disorders, Circadian Rhythm Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University Faculty of Nursing

Erzurum, 25000, Turkey (Türkiye)

About this study

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.

All procedures were conducted in accordance with the Declaration of Helsinki. Ethical approval was obtained from the relevant institutional ethics committee, and written informed consent was obtained from all participants prior to enrollment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Eye Mask-Based Blackout Protocol

Other

A non-pharmacological nursing intervention involving the use of an eye mask during nighttime sleep to reduce light exposure and support circadian rhythm regulation in intensive care unit patients.

Primary outcomes

  1. Sleep quality (Richard-Campbell Sleep Questionnaire [RCSQ] total score)

    Time frame: 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.

Secondary outcomes

  1. Sleep quality (Visual Analogue Scale [VAS], 1-10)

    Time frame: 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).

    Self-reported sleep quality rated on a 1-10 scale (1 = worst sleep quality, 10 = best sleep quality).

  2. Urinary 6-sulfatoxymelatonin (aMT6s) level (ng/mg creatinine)

    Time frame: 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

    Change in melatonin secretion assessed by urinary 6-sulfatoxymelatonin (aMT6s) measured by ELISA and normalized to urinary creatinine (ng/mg creatinine). Urine was collected via Foley catheter drainage.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

The Effect of an Eye Mask-Based Blackout Protocol on Patients' Sleep Quality and Melatonin Levels: A Randomised Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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