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

Craniotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04959968
• Other study ID #: TaksimEgitim
• Status: Completed
• Phase: N/A
• Start date: July 10, 2021
• Est. completion date: June 17, 2023

Study information

• Verified date: October 2022
• Source: Taksim Egitim ve Arastirma Hastanesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 17, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Craniotomy

Intervention

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

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Taksim Egitim ve Arastirma Hastanesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Richards-Campbell Sleep Questionnaire	Sleep quality levels of the craniotomy cases	On the 1 day of craniotomy
Primary	The Richards-Campbell Sleep Questionnaire	Sleep quality levels of the craniotomy cases	Post-operative second day of craniotomy
Secondary	The Hospital Anxiety and Depression Scale	Anxiety levels of the craniotomy cases	On the 1 day of craniotomy
Secondary	The Hospital Anxiety and Depression Scale	Anxiety levels of the craniotomy cases	Post-operative second day of craniotomy
Secondary	The General Comfort Questionnaire	General comfort levels of the craniotomy cases	Post-operative second day of craniotomy