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NCT Number: NCT04959968

The Use of Eye Patches and Earplugs in Intensive Care in Cases of Craniotomy.

This study aims to evaluate the effects of using eye patch and earplugs on anxiety, patient comfort, and sleep quality after craniotomy. The study will be carried out in a hospital located in the Northwest of Turkey. A total of 60 patients meeting the research criteria will be randomized to intervention and control groups. An eye patch and earplug will be applied to the intervention group in the intensive care unit on the day of craniotomy and on the post-operative 1st day between 22:00 and 06:00. Standard care procedure will be applied to the control group. Richard-Campbell Sleep Questionnaire, Aktiwatch, Hospital Anxiety and Depression Scale and General Comfort Questionnaire will be used to collect study data.

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Key information

Conditions

Craniotomy Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpaşa Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

This study was designed as a non-drug clinical study with 2 randomly selected groups to evaluate the effect of eye patch and earplug use on sleep quality, anxiety and comfort level in patients hospitalized in the intensive care unit after craniotomy. The study will be carried out in a hospital located in the Northwest of Turkey. A total of 60 patients meeting the research criteria will be randomized to intervention and control groups. An eye patch and earplug will be applied to the intervention group in the intensive care unit on the day of craniotomy and on the post-operative 1st day between 22:00 and 06:00. Standard care procedure will be applied to the control group. Richard-Campbell Sleep Questionnaire, Aktiwatch, Hospital Anxiety and Depression Scale and General Comfort Questionnaire will be used to collect study data.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients scheduled for elective craniotomy and intensive care for at least 48 hours
  • Glasgow Coma Scale score = 15
  • Turkish literate

Exclusion criteria

  • Diagnosis of sleep disorder
  • Hearing and/or vision loss
  • Hearing aid use
  • Pregnant women
  • Communication and/or cooperation problem
  • Chronic pain medication

Treatment and study plan

eye patch and earplug

Device

The use of eye patch and ear plugs in post-operative intensive care in craniotomy cases.

Primary outcomes

  1. The Richards-Campbell Sleep Questionnaire

    Time frame: On the 1 day of craniotomy

    Sleep quality levels of the craniotomy cases

  2. The Richards-Campbell Sleep Questionnaire

    Time frame: Post-operative second day of craniotomy

    Sleep quality levels of the craniotomy cases

Secondary outcomes

  1. The Hospital Anxiety and Depression Scale

    Time frame: On the 1 day of craniotomy

    Anxiety levels of the craniotomy cases

  2. The Hospital Anxiety and Depression Scale

    Time frame: Post-operative second day of craniotomy

    Anxiety levels of the craniotomy cases

  3. The General Comfort Questionnaire

    Time frame: Post-operative second day of craniotomy

    General comfort levels of the craniotomy cases

Sponsors and collaborators

Lead sponsor

Taksim Egitim ve Arastirma Hastanesi

Other Gov

Registry information

Official study title

The Effect of Use of Eye Bands and Earplugs on Sleep Quality, Anxiety and Comfort Level in Patients Undergoing Craniotomy Surgery

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2021
Registry last updated
Aug 21, 2023

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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