Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT06876194
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2025-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Music on the Sedation Quality Among Children in the Emergency Department.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-03-08', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sedation depth', 'timeFrame': 'Interval between start to the end of the procedure, an average of 30 minute', 'description': 'Using the Pediatric Sedation State Scale (PSSS), we will assess the sedation depth of the children.'}], 'secondaryOutcomes': [{'measure': 'Adverse effect', 'timeFrame': 'Interval between injection to the end of recovery for 2 hours', 'description': 'Using standard definitions, the adverse effects will be assessed.'}, {'measure': 'Recovery condition', 'timeFrame': 'Interval between the end of the procedure to the full recovery for 2 hours', 'description': 'using a three-level scale, we will assess the child recovery condition.'}, {'measure': "Physicians' satisfaction", 'timeFrame': 'Interval between start to the end of the procedure, an average of 30 minute', 'description': "We will use the 5-level Likert scale to assess the physicians' satisfaction with the sedation and procedure."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sedation']}, 'descriptionModule': {'briefSummary': 'Children presenting to the emergency department frequently experience anxiety and may undergo various painful procedures. While sedative agents are administered to these patients, they do not consistently provide adequate relief to keep the child calm and cooperative during the procedures. Implementing non-pharmacological interventions, such as music, might enhance the efficacy of sedation, resulting in a better experience for these patients and more favorable outcomes.', 'detailedDescription': 'This is an interventional single-blinded randomized clinical trial on children presenting to the emergency department of Imam Khomeini Hospital in Tehran. The estimated sample size is 42 patients in each group considering a 5% margin of error and 80% power. The efficacy of analgesia and sedation and adverse effects are measured using a predefined form. for the description of qualitative data, frequency will be used and for quantitative data, the T-Test, ANOVA, mean and SD will be employed. For examining differences between the two groups, Chi-Square, T-Test, and ANOVA will be utilized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between 0-14 years of age\n* Requiring analgesia or sedation for medical procedures\n\nExclusion Criteria:\n\n* Lack of consent from parents or legal guardian of the child\n* Hearing impairment\n* Any developmental disorder'}, 'identificationModule': {'nctId': 'NCT06876194', 'briefTitle': 'The Effect of Music on the Sedation Quality Among Children in the Emergency Department.', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'The Effectiveness of Music on The Procedural Sedation and Analgesia Quality Among Children in The Emergency Department.', 'orgStudyIdInfo': {'id': '9811307001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Music', 'description': 'A previously defined list of songs will be administered to these patients during the procedure.', 'interventionNames': ['Other: Music intervention']}, {'type': 'NO_INTERVENTION', 'label': 'No music'}], 'interventions': [{'name': 'Music intervention', 'type': 'OTHER', 'description': 'A previously defined list of songs will be administered to these patients during the procedure.', 'armGroupLabels': ['Music']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'IKHC', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Hadi Mirfazaelian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tehran University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The information is not allowed to be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hadi Mirfazaelian', 'investigatorAffiliation': 'Tehran University of Medical Sciences'}}}}