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The Eye Patch and Headset on Sleep Quality, Anxiety, Fear and Vital Signs | Clinical Trials | Clareo Health

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The Eye Patch and Headset on Sleep Quality, Anxiety, Fear and Vital Signs

The Effect of Eye Patch and Headset on Sleep Quality, Anxiety, Fear and Vital Signs in Intensive Care Patients: A Randomized Controlled Study

NCT05451186•Istanbul Sabahattin Zaim University

View on ClinicalTrials.gov

Summary

This study was planned to investigate the effects of eye patch and headphones on sleep quality, anxiety, fear and vital signs in coronary intensive care unit patients.

Detailed Description

In intensive care units, it can be much easier to change the environment perception of patients with simple tools such as headphones and sleep bands, rather than changing the environment of the patients. The use of sleep bands and headphones, which are non-pharmacological methods, can reduce sleep deprivation by changing the environmental perception of the patients.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Being 18 years or older,
•New York Heart Association (NYHA) functional class II and III,
•Not having received any general anaesthesia for the previous 24 hours,
•Not having received any sedative medications or opioids for the past 24 hours,
•Not having a verbal communication disability (hearing and speaking),
•Absence of pain,
•Not having a previously diagnosed sleep disorder,
•Not having psychiatric problems,
•Not having a cognitive problem,
•Being healthy enough to put on and take off earplugs independently, in addition to wearing an eye mask and removing it when necessary, and continuing to be hospitalized for at least three days.

Exclusion Criteria

•Diagnosed with delirium (Intensive care delirium screening checklist \>=5),
•Unconscious (Glasgow coma scale\<13),
•Presence of additional chronic diseases,
•Having consumed coffee, alcohol and hypnotic drugs at least 12 hours before the study,
•Patients whose condition suddenly worsened,
•Those who cannot use earplugs and eye masks effectively at night,
•Those who voluntarily withdrew from the study and were transferred from the intensive care unit.

Locations (1)

Istanbul Sabahattin Zaim University, Faculty of Health Sciences

Istanbul, Turkey (Türkiye)

Key Dates

Start Date

June 20, 2022

Primary Completion Date

November 15, 2022

Completion Date

November 15, 2022

Last Updated

February 13, 2023

Enrollment

ACTUAL participants

Conditions

Intensive Care Unit Syndrome

Interventions

Eye patch and headphones

OTHER

Cerebral Perfusion Variation During Blood Pressure Changes in ICU

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Eye Patch and Headset on Sleep Quality, Anxiety, Fear and Vital Signs

Inclusion Criteria

Exclusion Criteria

Cerebral Perfusion Variation During Blood Pressure Changes in ICU

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