Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT03544502
Status:
COMPLETED
Last Update Posted:
2018-06-01
First Post:
2018-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Is Music the Food of Anesthesia in Children?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-21', 'studyFirstSubmitDate': '2018-04-11', 'studyFirstSubmitQcDate': '2018-05-21', 'lastUpdatePostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperatively, Emergence delirium (ED) was assessed as a Pediatric Anesthesia Emergence Delirium', 'timeFrame': '15 minutes in postoperative', 'description': 'Pediatric Anesthesia Emergence Delirium Score was assessed postoperative 15th minutes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['music, anesthesia, surgery'], 'conditions': ['Music']}, 'referencesModule': {'references': [{'pmid': '36474510', 'type': 'DERIVED', 'citation': 'Hekimoglu Sahin S, Duran R, Basaran UN, Sut N, Colak A, Duran S. Is music the food of the anesthesia in children? World J Pediatr Surg. 2022 Mar 1;5(2):e000328. doi: 10.1136/wjps-2021-000328. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': "The patients were randomly separated into three groups. Group M (n=35) applied CD player and Group S (n=35) received the independent anesthesiologist placed earplugs into the patients' ears. Group N (n=35) exposed to the ambient operating room noise.", 'detailedDescription': "Hundred and five pediatric patients who scheduled for abdominal surgery in ASA I-II risk groups were enrolled in the study. The patients were randomly separated into three groups. Group M (n=35) applied CD player and Group S (n=35) received the independent anesthesiologist placed earplugs into the patients' ears. Group N (n=35) exposed to the ambient operating room noise. The preoperative children's anxiety levels were assessed with the M-YPAS in the operating room. Heart rate (HR) and mid-arterial pressure (MAP) were recorded at 30-minute intervals until the completion of surgery, end of surgery and postoperative. During each measurement, noise level recordings were performed using sonometre. Pediatric Anesthesia Emergence Delirium Score (PEAD) was assessed after extubation, postoperative."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '5 Years', 'genderBased': True, 'genderDescription': 'age from 5 to 9 years of age', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for elective abdominal surgery with an expected operation time of 60 to 120 minutes, were enrolled in the study.\n\nExclusion Criteria:\n\n* Children were excluded from the study if they had cognitive disorders, with clinically evident hearing impairment, chronic illness, undergoing emergency surgery, and unstable medical conditions requiring intensive care unit admission.'}, 'identificationModule': {'nctId': 'NCT03544502', 'briefTitle': 'Is Music the Food of Anesthesia in Children?', 'organization': {'class': 'OTHER', 'fullName': 'Trakya University'}, 'officialTitle': 'Is Music the Food of Anesthesia in Children?', 'orgStudyIdInfo': {'id': 'TUTF-GOKAEK 2013/147'}, 'secondaryIdInfos': [{'id': 'TUTF-GOKAEK', 'type': 'REGISTRY', 'domain': 'Local Ethic'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music group', 'description': "Music group (group M, n=35) patients applied CD player. One CDs were prepared with 5 children's songs (classic music) for the study. CD player opened during anesthesia induction and continued until postoperative 15 minute", 'interventionNames': ['Device: CD player', 'Device: CEL-480 Sound Level Meter Sonometre']}, {'type': 'EXPERIMENTAL', 'label': 'Silence group', 'description': "silence group (group S, n=35) patients received the independent anesthesiologist applied earplugs into the patients' ears during anesthesia induction and the earplugs were removed immediately before tracheal tube extubation.\n\nDuring each measurement, noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.", 'interventionNames': ['Device: CEL-480 Sound Level Meter Sonometre', 'Device: Earplug']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Noise group', 'description': 'noise group (group N, n=35) patients were exposed to the ambient operating room noise.\n\nNoise level recordings were performed using CEL-480 Sound Level Meter Sonometre.Postoperatively, Emergence delirium (ED) was assessed as a Pediatric Anesthesia Emergence Delirium (PAED) Score ≥ 10.', 'interventionNames': ['Device: CEL-480 Sound Level Meter Sonometre', 'Procedure: Ambient operating room noise']}], 'interventions': [{'name': 'CD player', 'type': 'DEVICE', 'otherNames': ['player'], 'description': 'CD player opened during anesthesia induction and continued until postoperative 15 minute', 'armGroupLabels': ['Music group']}, {'name': 'CEL-480 Sound Level Meter Sonometre', 'type': 'DEVICE', 'otherNames': ['Sonometre'], 'description': 'Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.', 'armGroupLabels': ['Music group', 'Noise group', 'Silence group']}, {'name': 'Earplug', 'type': 'DEVICE', 'description': "the independent anesthesiologist placed earplug into the patients' ears during anesthesia induction and the ear plug were removed immediately before tracheal tube extubation.", 'armGroupLabels': ['Silence group']}, {'name': 'Ambient operating room noise', 'type': 'PROCEDURE', 'description': 'patients were exposed to the ambient operating room noise.', 'armGroupLabels': ['Noise group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trakya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Sevtap Hekimoglu Sahin', 'investigatorAffiliation': 'Trakya University'}}}}