Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-06 @ 1:10 AM
Study NCT ID:
NCT04959968
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2021-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Eye Patches and Earplugs in Intensive Care in Cases of Craniotomy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004430', 'term': 'Ear Protective Devices'}], 'ancestors': [{'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011481', 'term': 'Protective Clothing'}, {'id': 'D003020', 'term': 'Clothing'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-16', 'studyFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Richards-Campbell Sleep Questionnaire', 'timeFrame': 'On the 1 day of craniotomy', 'description': 'Sleep quality levels of the craniotomy cases'}, {'measure': 'The Richards-Campbell Sleep Questionnaire', 'timeFrame': 'Post-operative second day of craniotomy', 'description': 'Sleep quality levels of the craniotomy cases'}], 'secondaryOutcomes': [{'measure': 'The Hospital Anxiety and Depression Scale', 'timeFrame': 'On the 1 day of craniotomy', 'description': 'Anxiety levels of the craniotomy cases'}, {'measure': 'The Hospital Anxiety and Depression Scale', 'timeFrame': 'Post-operative second day of craniotomy', 'description': 'Anxiety levels of the craniotomy cases'}, {'measure': 'The General Comfort Questionnaire', 'timeFrame': 'Post-operative second day of craniotomy', 'description': 'General comfort levels of the craniotomy cases'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety', 'Sleep', 'Intensive Care, Surgical', 'Craniotomy'], 'conditions': ['Craniotomy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective craniotomy and intensive care for at least 48 hours\n* Glasgow Coma Scale score = 15\n* Turkish literate\n\nExclusion Criteria:\n\n* Diagnosis of sleep disorder\n* Hearing and/or vision loss\n* Hearing aid use\n* Pregnant women\n* Communication and/or cooperation problem\n* Chronic pain medication'}, 'identificationModule': {'nctId': 'NCT04959968', 'briefTitle': 'The Use of Eye Patches and Earplugs in Intensive Care in Cases of Craniotomy.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taksim Egitim ve Arastirma Hastanesi'}, 'officialTitle': 'The Effect of Use of Eye Bands and Earplugs on Sleep Quality, Anxiety and Comfort Level in Patients Undergoing Craniotomy Surgery', 'orgStudyIdInfo': {'id': 'TaksimEğitim'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention 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', 'interventionNames': ['Device: eye patch and earplug']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Standard care procedure will be applied to the control group'}], 'interventions': [{'name': 'eye patch and earplug', 'type': 'DEVICE', 'description': 'The use of eye patch and ear plugs in post-operative intensive care in craniotomy cases.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziosmanpaşa Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taksim Egitim ve Arastirma Hastanesi', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}