Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-27 @ 8:10 AM
Study NCT ID:
NCT01858350
Status:
COMPLETED
Last Update Posted:
2013-05-21
First Post:
2013-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of CAM Therapies in Pediatric Patients Undergoing Sedation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 471}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-16', 'studyFirstSubmitDate': '2013-05-13', 'studyFirstSubmitQcDate': '2013-05-16', 'lastUpdatePostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for sedation medications for MRI is reduced', 'timeFrame': 'The Time Frame for the outcome measures are at the start of the intervention and immediately following the procedure (average about 150 minutes). No further follow up was conducted.', 'description': 'Intervention is performed prior to sedation. Following sedation, the patient undergoes MRI. After the MRI is completed, the amount of sedation given to the patient is recorded. No other follow up is required.'}], 'secondaryOutcomes': [{'measure': 'To measure the effect of the interventions on salivary cortisol and inflammatory cytokines', 'timeFrame': 'Saliva samples were collected before the intervention and then after the MRI was performed (average about 150 minutes).', 'description': 'The aim of this measure was to determine if the interventions changed the levels of salivary cortisol and inflammatory cytokines'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CAM', 'Sedation', 'MRI', 'Music Therapy'], 'conditions': ['Neurological Disorders']}, 'descriptionModule': {'briefSummary': 'The investigators conducted a prospective open unblinded clinical four-arm evaluation of Complementary and Alternate Medicine (CAM) interventions on children 1-12 years of age who were undergoing imaging by Medical Resonance Imaging(MRI) and receiving parenteral sedation. Children were assigned to active music therapy, passive music therapy, distraction therapy, and no intervention; measures included doses and numbers of sedation medications, time of sedation, and salivary levels of the stress hormone cortisol and pro-inflammatory cytokines, before and immediately after the intervention was completed. The Time Frame for the outcome measures are at the start of the intervention and immediately following the procedure (generally about 150 minutes). No further follow up was conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children ages 1-12 years undergoing MRI studies\n\nExclusion Criteria:\n\n* Patients with significant congenital anomalies, genetic syndromes and central nervous system malformations'}, 'identificationModule': {'nctId': 'NCT01858350', 'briefTitle': 'Comparison of the Effectiveness of CAM Therapies in Pediatric Patients Undergoing Sedation', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Comparison of the Effectiveness of Complementary and Alternative Medicine (CAM) Therapies in Pediatric Patients Undergoing Medical Resonance Imagining (MRI) Studies', 'orgStudyIdInfo': {'id': 'RC1AT005699', 'link': 'https://reporter.nih.gov/quickSearch/RC1AT005699', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Active Music Therapy', 'description': 'Active Music Therapy: A music therapist plays music to patients for 15 minutes', 'interventionNames': ['Other: Active Music Therapy']}, {'type': 'OTHER', 'label': 'Passive Music Therapy', 'description': 'Passive Music Therapy: A music therapist plays a compact disc (CD) to patients for 15 minutes', 'interventionNames': ['Other: Passive Music Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention'}, {'type': 'OTHER', 'label': 'Distraction Therapy', 'description': 'Distraction Therapy: A child life specialist plays with patients for 15 minutes', 'interventionNames': ['Other: Distraction Therapy']}], 'interventions': [{'name': 'Active Music Therapy', 'type': 'OTHER', 'armGroupLabels': ['Active Music Therapy']}, {'name': 'Passive Music Therapy', 'type': 'OTHER', 'armGroupLabels': ['Passive Music Therapy']}, {'name': 'Distraction Therapy', 'type': 'OTHER', 'armGroupLabels': ['Distraction Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Wayne State University and Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Ambika MATHUR, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wayne State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ambika Mathur', 'investigatorAffiliation': 'Wayne State University'}}}}