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

Sleep Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05564351
• Other study ID #: "A.KAZAK33-H.TOPALI31"!
• Status: Completed
• Phase: N/A
• Start date: October 10, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: September 2022
• Source: Mersin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 1, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Quality

Intervention

Other:
• eye mask and ear plug
black eye mask and silicon ear plug

Locations

Country	Name	City	State
Turkey	Siirt State Hospital	Siirt

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	Visual Analog Scale	The scale developed by Price et al. in 1983 measures the severity of the patient's pain.	Three day