The Use of Eye Patches and Earplugs in Intensive Care in Cases of Craniotomy.
The Effect of Use of Eye Bands and Earplugs on Sleep Quality, Anxiety and Comfort Level in Patients Undergoing Craniotomy Surgery
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2021
CompletedStudy Start
First participant enrolled
July 10, 2021
CompletedFirst Posted
Study publicly available on registry
July 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2023
CompletedAugust 21, 2023
October 1, 2022
1.8 years
June 25, 2021
August 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
The Hospital Anxiety and Depression Scale
On the 1 day of craniotomy
The Hospital Anxiety and Depression Scale
Post-operative second day of craniotomy
The General Comfort Questionnaire
Post-operative second day of craniotomy
Study Arms (2)
Intervention group
EXPERIMENTALAn 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
Control group
NO INTERVENTIONStandard care procedure will be applied to the control group
Interventions
The use of eye patch and ear plugs in post-operative intensive care in craniotomy cases.
Eligibility Criteria
You may qualify if:
- Patients scheduled for elective craniotomy and intensive care for at least 48 hours
- Glasgow Coma Scale score = 15
- Turkish literate
You may not qualify if:
- Diagnosis of sleep disorder
- Hearing and/or vision loss
- Hearing aid use
- Pregnant women
- Communication and/or cooperation problem
- Chronic pain medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gaziosmanpaşa Training and Research Hospital
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2021
First Posted
July 13, 2021
Study Start
July 10, 2021
Primary Completion
April 10, 2023
Study Completion
June 17, 2023
Last Updated
August 21, 2023
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share