Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-01 @ 7:01 AM
Study NCT ID:
NCT05564351
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2022-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ear Plug and Eye Mask Use on Sleep Quality in Intensive Care Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2022-09-28', 'studyFirstSubmitQcDate': '2022-09-28', 'lastUpdatePostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Glasgow Coma Scale', 'timeFrame': 'Three day', 'description': "The GCS was developed in Scotland/Glasgow in 1974 and is an international measurement tool that reflects the patient's state of consciousness. In the GCS, scoring is done in three separate sections: eye opening, verbal and motor response."}, {'measure': 'Patient Information Form', 'timeFrame': 'one day', 'description': "In this form, which was created by the researchers by scanning the literature; There are 13 questions in total, including patients' age, gender, marital status, education level, medical diagnosis, chronic diseases, drugs used, length of hospital stay and sleep habits, etc."}], 'primaryOutcomes': [{'measure': 'Richards Campbell Sleep Scale', 'timeFrame': 'Three day', 'description': 'RCSS is a six-item scale that evaluates the depth of night sleep, the time to fall asleep, the frequency of waking, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'Three day', 'description': "The scale developed by Price et al. in 1983 measures the severity of the patient's pain."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nursing, intensive care unit, ear plug, eye mask, sleep quality'], 'conditions': ['Sleep Quality']}, 'descriptionModule': {'briefSummary': 'This study was conducted as a pre-test and post-test randomized controlled single center study to evaluate the effect of ear plugs and eye mask application on sleep quality in patients hospitalized in the intensive care unit. 120 patients who received inpatient treatment in Siirt State Hospital general intensive care unit constitute the sample of the study. The sample consist of four groups: ear plug group (n=30), eye mask group (n=30), earplug-eye mask group (n=30) and control group (n=30). Data were collected using the "Patient Identification Form, Glasgow Coma Skale, Visual Analog Scale, Richards-Campbell Sleep Questionnaire (RCSQ), ear plug and eye mask". As a preliminary test, RCSQ was applied in the morning of the second day after the first night sleep of the patients. Then, according to the group they were assigned to, the patients were allowed to sleep by applying only ear plug, eye mask only and simultaneous ear plug-eye mask between 22:00-06:00. As a final test, RCSQ was readministered to patients on the morning of the third day after the second night\'s sleep. During the analysis of the data, frequency, number, mean, Student t test and/or Mann- Whitney U test, ANOVA and/or Kruskal- Wallis test, t test or Wilcoxon Sign test, chi-square test were used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBeing 18 years or older\n\n* Being literate\n* No hearing impairment\n* Ability to communicate verbally\n* Receiving inpatient treatment in the GICU for at least 3 days\n* Have 15 Glasgow Coma Scale (GCS) scores (Minimum scores will be as follows. 3 points from eye response; 5 points from motor response; 2 points from verbal response)\n* Agreeing to participate in the research\n\nExclusion Criteria:\n\nHaving a Visual Analog Scale (VAS) score above 7\n\n* Using sleeping pills or sedative drugs\n* Being treated with a diagnosis of sleep disorder\n* Being on mechanical ventilation\n* Having an active ear or eye infection\n* Having a diagnosed psychiatric illness'}, 'identificationModule': {'nctId': 'NCT05564351', 'briefTitle': 'Ear Plug and Eye Mask Use on Sleep Quality in Intensive Care Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mersin University'}, 'officialTitle': 'Evaluation of the Effect of Ear Plug and Eye Mask Use on Sleep Quality in Intensive Care patıents: Randomized Controlled Study', 'orgStudyIdInfo': {'id': '"A.KAZAK33-H.TOPALI31"!'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ear plug group', 'interventionNames': ['Other: eye mask and ear plug']}, {'type': 'EXPERIMENTAL', 'label': 'Eye mask group', 'interventionNames': ['Other: eye mask and ear plug']}, {'type': 'EXPERIMENTAL', 'label': 'Eye mask+Ear plug group', 'interventionNames': ['Other: eye mask and ear plug']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'eye mask and ear plug', 'type': 'OTHER', 'description': 'black eye mask and silicon ear plug', 'armGroupLabels': ['Ear plug group', 'Eye mask group', 'Eye mask+Ear plug group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Siirt', 'country': 'Turkey (Türkiye)', 'facility': 'Siirt State Hospital', 'geoPoint': {'lat': 37.9293, 'lon': 41.94134}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mersin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'AYSUN KAZAK', 'investigatorAffiliation': 'Mersin University'}}}}