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

Taksim Egitim ve Arastirma Hastanesi

Status: Completed

Conditions: Craniotomy

Treatments: Device: eye patch and earplug

Study type: Interventional

Funder types: Other

Identifiers

NCT04959968

TaksimEğitim

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Device: eye patch and earplug

Control group

No Intervention group

Description:

Standard care procedure will be applied to the control group