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NCT Number: NCT05970614

The Effect of Eye Masks and Earplugs In Intensive Care Unit Patients

This study was planned as a randomized controlled and experimental study to evaluate the effect of eye masks and earplugs on sleep quality and vital signs in intensive care patients.

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Key information

Conditions

Sleep Quality Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Vital Signs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osmaniye Public Hospital

Osmaniye, Merkez, 80000, Turkey (Türkiye)

About this study

The research will be conducted with 60 patients hospitalized in the intensive care units of a state hospital. Research data will be collected with a questionnaire, vital signs follow-up form, insomnia severity index, and Richards-Campbell Sleep Quality Scale. Patients will be divided into intervention and control groups. Eye mask and ear plugs will be applied to the intervention group for 3 days, and the control group will receive routine care. The study will be terminated after 3 days of follow-up for each patient.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years and over,
  • Able to answer all questions and communicate,
  • Those who agreed to participate in the research
  • Being in the category of insomnia, moderate insomnia, or severe insomnia according to the insomnia severity index,
  • Not sedating
  • Not connected to a ventilator
  • No hearing problem
  • Glasgow Coma Score of 15

Exclusion criteria

  • Connecting to the ventilator during operation
  • Sedation during the study
  • Wanting to leave the research during the study
  • Being in the intervention group and removing the eye patch or earplug during sleep
  • GCS falling below 15

Treatment and study plan

Eye masks and ear plugs

Other

Eye masks and ear plugs will be applied to patients for 3 days between 22:00 and 06:00.

Primary outcomes

  1. Personal questionnaire

    Time frame: Only one times. At the first meeting (up to one day).

    It is a form consisting of 22 questions in order to investigate the sociodemographic characteristics and health status of the patients.

  2. Vital signs follow-up form

    Time frame: up to 3 days

    It will be used to measure patients' fever, pulse, respiration, blood pressure and sPO2 values. It will be applied to patients at 22, 02, 06 hours. Also, the daily average hour will be calculated at the end of each day.

  3. Insomnia Severity Index

    Time frame: up to 3 days

    It will be used to measure the severity of insomnia in patients. It consists of 7 questions and each question can receive points between 0 and 4. A maximum score of 28 and a minimum score of 0 are obtained on the scale, and as the score increases, the severity of insomnia increases.

  4. Richards-Campbell Sleep Scale

    Time frame: up to 3 days

    The scale consists of 6 questions and the question is between 0 and 100 points. The higher the score, the higher the sleep quality.

Sponsors and collaborators

Lead sponsor

Osmaniye Korkut Ata University

Other

Registry information

Official study title

The Effect of Eye Masks and Earplugs on Sleep Quality and Life Findings In Intensive Care Unit Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Nov 7, 2024

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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