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

Not Applicable

Completed

• Conditions: Craniotomy
• Interventions: Device: eye patch and earplug

• Registration Number: NCT04959968
• Lead Sponsor: Taksim Egitim ve Arastirma Hastanesi

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-06-25
• Study Start: 2021-07-10
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-13
• Status Verified: 2022-10
• Primary Completion: 2023-04-10
• Study Completion: 2023-06-17
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	eye patch and earplug	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

Primary Outcome Measures

Name	Time	Method
The Richards-Campbell Sleep Questionnaire	Post-operative second day of craniotomy	Sleep quality levels of the craniotomy cases

Secondary Outcome Measures

Name	Time	Method
The General Comfort Questionnaire	Post-operative second day of craniotomy	General comfort levels of the craniotomy cases
The Hospital Anxiety and Depression Scale	Post-operative second day of craniotomy	Anxiety levels of the craniotomy cases

Trial Locations

Locations (1)

Gaziosmanpaşa Training and Research Hospital; 🇹🇷 Istanbul, Turkey