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Clinical Trials/NCT05564351
NCT05564351
Completed
Not Applicable

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

Mersin University1 site in 1 country120 target enrollmentOctober 10, 2021
ConditionsSleep Quality

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Quality
Sponsor
Mersin University
Enrollment
120
Locations
1
Primary Endpoint
Richards Campbell Sleep Scale
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 10, 2021
End Date
June 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

AYSUN KAZAK

Lecturer

Mersin University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Richards Campbell Sleep Scale

Time Frame: 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 Outcomes

  • Visual Analog Scale(Three day)

Study Sites (1)

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