Clinical trial NCT04959968: The Use of Eye Patches and Earplugs in Intensive Care in Cases of Craniotomy.
Official title: The Effect of Use of Eye Bands and Earplugs on Sleep Quality, Anxiety and Comfort Level in Patients Undergoing Craniotomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Craniotomy
Keywords: Anxiety
Sleep
Intensive Care, Surgical
Craniotomy
Lead sponsor: Taksim Egitim ve Arastirma Hastanesi
Sponsor class: OTHER_GOV
First posted: 2021-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Richards-Campbell Sleep Questionnaire
timeFrame: On the 1 day of craniotomy
measure: The Richards-Campbell Sleep Questionnaire
timeFrame: Post-operative second day of craniotomy
Secondary outcomes:
measure: The Hospital Anxiety and Depression Scale
timeFrame: On the 1 day of craniotomy
measure: The Hospital Anxiety and Depression Scale
timeFrame: Post-operative second day of craniotomy
measure: The General Comfort Questionnaire
timeFrame: Post-operative second day of craniotomy
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpaşa Training and Research Hospital
Study officials:
References: