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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05564351
Enrollment
120
Registered
2022-10-03
Start date
2021-10-10
Completion date
2022-06-01
Last updated
2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Quality

Keywords

Nursing, intensive care unit, ear plug, eye mask, sleep quality

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.

Interventions

OTHEReye mask and ear plug

black eye mask and silicon ear plug

Sponsors

Mersin University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Richards Campbell Sleep ScaleThree dayRCSS 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

MeasureTime frameDescription
Visual Analog ScaleThree dayThe scale developed by Price et al. in 1983 measures the severity of the patient's pain.

Other

MeasureTime frameDescription
Glasgow Coma ScaleThree dayThe 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.
Patient Information Formone dayIn 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026