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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Craniotomy

Intervention / Treatment
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* Device: eye patch and earplug


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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 | Device: eye patch and earplug<br>* The use of eye patch and ear plugs in post-operative intensive care in craniotomy cases.<br>|
| No Intervention: Control group<br>Standard care procedure will be applied to the control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Richards-Campbell Sleep Questionnaire | Sleep quality levels of the craniotomy cases | On the 1 day of craniotomy | 
| The Richards-Campbell Sleep Questionnaire | Sleep quality levels of the craniotomy cases | Post-operative second day of craniotomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Hospital Anxiety and Depression Scale | Anxiety levels of the craniotomy cases | On the 1 day of craniotomy | 
| The Hospital Anxiety and Depression Scale | Anxiety levels of the craniotomy cases | Post-operative second day of craniotomy | 
| The General Comfort Questionnaire | General comfort levels of the craniotomy cases | Post-operative second day of craniotomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Craniotomy, Anxiety, Sleep, Intensive Care, Surgical