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

Sponsor
Mersin University (Other)
Overall Status
Completed
CT.gov ID
NCT05564351
Collaborator
(none)
120
1
4
7.7
15.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: eye mask and ear plug
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of the Effect of Ear Plug and Eye Mask Use on Sleep Quality in Intensive Care patıents: Randomized Controlled Study
Actual Study Start Date :
Oct 10, 2021
Actual Primary Completion Date :
May 30, 2022
Actual Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Visual Analog Scale [Three day]

    The scale developed by Price et al. in 1983 measures the severity of the patient's pain.

Other Outcome Measures

  1. Glasgow Coma Scale [Three day]

    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.

  2. Patient Information Form [one day]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Siirt State Hospital Siirt Turkey

Sponsors and Collaborators

  • Mersin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AYSUN KAZAK, Lecturer, Mersin University
ClinicalTrials.gov Identifier:
NCT05564351
Other Study ID Numbers:
  • "A.KAZAK33-H.TOPALI31"!
First Posted:
Oct 3, 2022
Last Update Posted:
Oct 3, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AYSUN KAZAK, Lecturer, Mersin University

Study Results

No Results Posted as of Oct 3, 2022