Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT06944093
Status:
COMPLETED
Last Update Posted:
2025-04-25
First Post:
2025-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Listen to a Audio Book
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-04-17', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agitation Scores', 'timeFrame': '10 month'}, {'measure': 'Breathing Rate', 'timeFrame': '10 month'}, {'measure': 'Breathing Depth', 'timeFrame': '10 month'}, {'measure': 'SpO₂ Levels', 'timeFrame': '10 month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Failure With Hypercapnia']}, 'descriptionModule': {'briefSummary': 'This study investigates how listening to audiobooks affects agitation scores and respiratory parameters (like breathing rate, depth, and oxygen saturation) in patients receiving non-invasive mechanical ventilation (NIMV) for hypercapnic respiratory failure in an intensive care unit. Participants will listen to an audiobook of their choice during their 2-hour NIMV treatment. Their agitation levels and respiratory parameters will be measured before, during, and after NIMV application. The goal is to evaluate whether audiobooks can reduce patient agitation and improve respiratory outcomes, offering a low-cost, easy-to-use, and effective approach for better patient care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients aged 18 years or older Patients hospitalized in the Chest Diseases Intensive Care Unit Diagnosed with Hypercapnic Respiratory Failure Undergoing Non-invasive Mechanical Ventilation (NIMV) No hearing impairment Conscious and alert patients\n\nExclusion Criteria:\n\nPatients unwilling to participate or wishing to withdraw from the study'}, 'identificationModule': {'nctId': 'NCT06944093', 'briefTitle': 'Listen to a Audio Book', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Noninvasive Mechanical Ventilation is Applied to Patients With Hypercapnic Respiratory Failure on the Agitation Scores and Respiratory Parameters', 'orgStudyIdInfo': {'id': 'B.30.2.ATA.0.01.00/169'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Listen to a audio book', 'interventionNames': ['Behavioral: audio book']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'audio book', 'type': 'BEHAVIORAL', 'description': 'Listen to a audio book', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Erzurum', 'state': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Atatürk University Faculty of Nursing', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Burak YAVUZ', 'investigatorAffiliation': 'Ataturk University'}}}}