Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-01 @ 7:01 AM
Study NCT ID:
NCT05564351
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2022-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ear Plug and Eye Mask Use on Sleep Quality in Intensive Care Patients
Sponsor:
Mersin University
Organization:
Study Overview
Official Title:
Evaluation of the Effect of Ear Plug and Eye Mask Use on Sleep Quality in Intensive Care patıents: Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: