Ear Plug and Eye Mask Use on Sleep Quality in Intensive Care Patients

Not Applicable

Completed

• Conditions: Sleep Quality
• Interventions: Other: eye mask and ear plug

• Registration Number: NCT05564351
• Lead Sponsor: Mersin University

Brief Summary

This study was conducted as a pre-test and post-test randomized controlled single center study to evaluate the effect of ear plugs and eye mask application on sleep quality in patients hospitalized in the intensive care unit. 120 patients who received inpatient treatment in Siirt State Hospital general intensive care unit constitute the sample of the study. The sample consist of four groups: ear plug group (n=30), eye mask group (n=30), earplug-eye mask group (n=30) and control group (n=30). Data were collected using the "Patient Identification Form, Glasgow Coma Skale, Visual Analog Scale, Richards-Campbell Sleep Questionnaire (RCSQ), ear plug and eye mask". As a preliminary test, RCSQ was applied in the morning of the second day after the first night sleep of the patients. Then, according to the group they were assigned to, the patients were allowed to sleep by applying only ear plug, eye mask only and simultaneous ear plug-eye mask between 22:00-06:00. As a final test, RCSQ was readministered to patients on the morning of the third day after the second night's sleep. During the analysis of the data, frequency, number, mean, Student t test and/or Mann- Whitney U test, ANOVA and/or Kruskal- Wallis test, t test or Wilcoxon Sign test, chi-square test were used.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-10
• Primary Completion: 2022-05-30
• Study Completion: 2022-06-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-28
• Last Update Submitted: 2022-09-28
• Study First Posted: 2022-10-03
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Being 18 years or older

• Being literate
• No hearing impairment
• Ability to communicate verbally
• Receiving inpatient treatment in the GICU for at least 3 days
• Have 15 Glasgow Coma Scale (GCS) scores (Minimum scores will be as follows. 3 points from eye response; 5 points from motor response; 2 points from verbal response)
• Agreeing to participate in the research

Exclusion Criteria

Having a Visual Analog Scale (VAS) score above 7

• Using sleeping pills or sedative drugs
• Being treated with a diagnosis of sleep disorder
• Being on mechanical ventilation
• Having an active ear or eye infection
• Having a diagnosed psychiatric illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eye mask+Ear plug group	eye mask and ear plug	-
Ear plug group	eye mask and ear plug	-
Eye mask group	eye mask and ear plug	-

Primary Outcome Measures

Name	Time	Method
Richards Campbell Sleep Scale	Three day	RCSS is a six-item scale that evaluates the depth of night sleep, the time to fall asleep, the frequency of waking, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale	Three day	The scale developed by Price et al. in 1983 measures the severity of the patient's pain.

Trial Locations

Locations (1)

Siirt State Hospital; 🇹🇷 Siirt, Turkey