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

NCT ID: NCT05564351

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-10
• Study Completion Date: 2022-06-01

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.

Conditions

Sleep Quality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Ear plug group

Group Type: EXPERIMENTAL

eye mask and ear plug

Intervention Type: OTHER

black eye mask and silicon ear plug

Eye mask group

Group Type: EXPERIMENTAL

eye mask and ear plug

Intervention Type: OTHER

black eye mask and silicon ear plug

Eye mask+Ear plug group

Group Type: EXPERIMENTAL

eye mask and ear plug

Intervention Type: OTHER

black eye mask and silicon ear plug

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

eye mask and ear plug

black eye mask and silicon ear plug

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

AYSUN KAZAK

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Siirt State Hospital

Siirt, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

"A.KAZAK33-H.TOPALI31"!

Identifier Type: -

Identifier Source: org_study_id