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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04959968
Enrollment
60
Registered
2021-07-13
Start date
2021-07-10
Completion date
2023-06-17
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniotomy

Keywords

Anxiety, Sleep, Intensive Care, Surgical, Craniotomy

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.

Interventions

DEVICEeye patch and earplug

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

Sponsors

Taksim Egitim ve Arastirma Hastanesi
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The Richards-Campbell Sleep QuestionnaireOn the 1 day of craniotomySleep quality levels of the craniotomy cases

Secondary

MeasureTime frameDescription
The Hospital Anxiety and Depression ScaleOn the 1 day of craniotomyAnxiety levels of the craniotomy cases
The General Comfort QuestionnairePost-operative second day of craniotomyGeneral comfort levels of the craniotomy cases

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026