Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-28 @ 8:47 PM
Study NCT ID:
NCT03901560
Status:
COMPLETED
Last Update Posted:
2019-04-05
First Post:
2019-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music Therapy: Sickle Cell and Pain Crisis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098644', 'term': 'Vaso-Occlusive Crises'}], 'ancestors': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2019-04-02', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'How does music therapy affect perceived pain in hospitalized pediatric patients?', 'timeFrame': '30 minutes', 'description': "Do pediatric patients who receive music therapy report a decrease in pain after receiving a music therapy intervention as measured by the Wong Baker Faces Scale? The Wong Baker Faces Scale uses six different faces to assist child patients in rating their pain on a scale of '0' for no pain to '10' for severe to extreme pain."}, {'measure': 'How does music therapy influence factors such as family satisfaction and length of stay at the time of discharge?', 'timeFrame': '30 minutes', 'description': 'Will music therapy result in patient and/or family satisfaction as measured by a survey administered immediately after the intervention?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sickle Cell Crisis', 'Functional Abdominal Pain', 'Patients Followed by the Pain Team']}, 'descriptionModule': {'briefSummary': 'This study will assess whether participants who receive music therapy during inpatient care report a decrease in pain and whether music therapy influences factors such as family satisfaction.', 'detailedDescription': 'The purpose of this study is to determine if music therapy services can serve as a viable, necessary, and beneficial aspect of inpatient pain management, distraction, and coping for pediatric patients in the acute care hospital setting. The investigator will note the effect of music therapy services in conjunction with pain scores reported by the participant and an increase in self and family reported coping skills during hospitalization.\n\nParticipants will be referred by providers from pain management service, oncology/hematology service, or the gastrointestinal (GI) service for functional and abdominal pain. Participants who meet the criteria for inclusion will be selected. The study will be explained to parents and a consent form will be left for the family to review and sign at their convenience. Participants will provide a pain scale level and vitals before completing the music therapy intervention. Once the music therapy intervention is completed, the pain scale and vitals will be repeated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients between the ages of 5-17 who either have sickle cell, are on the pain team, or functional abdominal pain', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 5-17 years of age\n* Admitted for sickle cell crisis, functional abdominal pain, or whom the pediatric pain management team is following.\n\nExclusion Criteria:\n\n* Non-English speaking\n* Under 5 years old and over 17 years old\n* Patients who are unable to hear or have a hearing disability\n* Developmentally unable to self-report pain levels'}, 'identificationModule': {'nctId': 'NCT03901560', 'briefTitle': 'Music Therapy: Sickle Cell and Pain Crisis', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'The Effect of Music Therapy on Pediatric Patients Admitted to the Hospital for Sickle Cell or Pain Crisis', 'orgStudyIdInfo': {'id': 'IRB 5897'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Music Therapy', 'type': 'OTHER'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'collaborators': [{'name': "The Children's Hospital at OU Medical Center", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}