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Completed

NCT Number: NCT05564351

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siirt State Hospital

Siirt, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eye mask and ear plug

Other

black eye mask and silicon ear plug

Primary outcomes

  1. 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

  1. Visual Analog Scale

    Time frame: Three day

    The scale developed by Price et al. in 1983 measures the severity of the patient's pain.

Other outcomes

  1. Glasgow Coma Scale

    Time frame: Three day

    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.

  2. Patient Information Form

    Time frame: one day

    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.

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 3, 2022
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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