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

NCT07385768 | Completed

• 1 other identifier: ATAUNI-SLEEP-ICU-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Disturbance; Circadian Rhythm Sleep Disorders; Intensive Care Unit Patients

Keywords

Eye mask; Light exposure; Melatonin; Sleep quality; Intensive care unit

Outcome Measures

Primary Outcomes (1)

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

  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.

  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).

Secondary Outcomes (2)

• 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

Study Arms (2)

Eye Mask Intervention Group

EXPERIMENTAL

Participants received a nighttime eye mask-based blackout protocol during sleep hours in the intensive care unit in addition to routine care.

Other: Eye Mask-Based Blackout Protocol

Control Group

NO INTERVENTION

Participants received routine intensive care without the use of an eye mask.

Interventions

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.

Eye Mask Intervention Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University Faculty of Nursing

Erzurum, Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parasomnias; Sleep Disorders, Circadian Rhythm; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Chronobiology Disorders; Dyssomnias; Occupational Diseases; Sleep Disorders, Intrinsic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomly assigned to either an intervention group or a control group and followed in parallel throughout the study period.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 4, 2026
• Study Start: August 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)