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

Evaluation of the Effect of Ear Plug and Eye Mask Use on Sleep Quality in Intensive Care patıents: Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Sleep Quality
• Intervention / Treatment: Other: eye mask and ear plug

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Siirt, Turkey
    • Siirt State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Ear plug group	Other: eye mask and ear plug; black eye mask and silicon ear plug
Experimental: Eye mask group	Other: eye mask and ear plug; black eye mask and silicon ear plug
Experimental: Eye mask+Ear plug group	Other: eye mask and ear plug; black eye mask and silicon ear plug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Richards Campbell Sleep Scale	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.	Three day

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glasgow Coma Scale	The GCS was developed in Scotland/Glasgow in 1974 and is an international measurement tool that reflects the patient's state of consciousness. In the GCS, scoring is done in three separate sections: eye opening, verbal and motor response.	Three day
Patient Information Form	In this form, which was created by the researchers by scanning the literature; There are 13 questions in total, including patients' age, gender, marital status, education level, medical diagnosis, chronic diseases, drugs used, length of hospital stay and sleep habits, etc.	one day

Collaborators and Investigators

• Sponsor: Mersin University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2021
• Primary Completion (Actual): May 30, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Nursing, intensive care unit, ear plug, eye mask, sleep quality
• Other Study ID Numbers: "A.KAZAK33-H.TOPALI31"!

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No