Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-02 @ 7:44 AM
Study NCT ID:
NCT02270060
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2014-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Music Therapy in Sickle Cell Pain Mixed Methods Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Samuel.RodgersMelnick@UHhospitals.org', 'phone': '216-844-7727', 'title': 'Samuel Rodgers-Melnick, MT-BC, music therapist', 'organization': 'University Hospitals Connor Integrative Health Network'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Small sample size and potential risk of bias, due to some participants having previous clinical relationships with the investigators prior to study initiation. We were unable to blind participants to their study condition assignments.'}}, 'adverseEventsModule': {'timeFrame': "Adverse event data were collected over the 20 month study period. For each participant, adverse event data was collected between baseline measurement of clinical outcomes and the end of each participant's participation in the study in the acute care clinic. This duration varied between 2 and 6 hours for each participant depending on his/her length of stay.", 'eventGroups': [{'id': 'EG000', 'title': 'Music Therapy Group', 'description': "Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.\n\nMusic Therapy: Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.", 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Music Listening Group', 'description': 'Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.\n\nMusic Listening: Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Group', 'description': 'Patient receives standard care and waits in treatment room/bay for twenty minutes.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Music Therapy Group', 'description': "Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.\n\nMusic Therapy: Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad."}, {'id': 'OG001', 'title': 'Music Listening Group', 'description': 'Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.\n\nMusic Listening: Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Patient receives standard care and waits in treatment room/bay for twenty minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.92', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '-1.92', 'spread': '2.50', 'groupId': 'OG001'}, {'value': '-1.19', 'spread': '1.69', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at end of 20-minute intervention, up to 120 minutes following randomization', 'description': 'Visual analog scale of pain intensity. The minimum score is 0. The maximum score is 10. Higher scores represent worse pain intensity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who participated in the music therapy intervention.'}, {'type': 'SECONDARY', 'title': 'Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Music Therapy Group', 'description': "Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.\n\nMusic Therapy: Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad."}, {'id': 'OG001', 'title': 'Music Listening Group', 'description': 'Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.\n\nMusic Listening: Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Patient receives standard care and waits in treatment room/bay for twenty minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.05', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '.86', 'spread': '4.01', 'groupId': 'OG001'}, {'value': '.45', 'spread': '1.97', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at end of 20-minute intervention, up to 120 minutes following randomization', 'description': 'Visual analog scale of Pain Relief. The minimum score is 0. The maximum score is 10. Higher scores represent greater pain relief.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who participated in the music therapy intervention.'}, {'type': 'SECONDARY', 'title': 'Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Music Therapy Group', 'description': "Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.\n\nMusic Therapy: Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad."}, {'id': 'OG001', 'title': 'Music Listening Group', 'description': 'Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.\n\nMusic Listening: Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Patient receives standard care and waits in treatment room/bay for twenty minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.33', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '.96', 'spread': '2.38', 'groupId': 'OG001'}, {'value': '.74', 'spread': '1.98', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at end of 20-minute intervention, up to 120 minutes following randomization', 'description': 'Visual analog scale of mood. The minimum score is 0. The maximum score is 10. Higher scores represent better mood.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who participated in the music therapy intervention.'}, {'type': 'SECONDARY', 'title': 'Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Music Therapy Group', 'description': "Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.\n\nMusic Therapy: Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad."}, {'id': 'OG001', 'title': 'Music Listening Group', 'description': 'Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.\n\nMusic Listening: Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Patient receives standard care and waits in treatment room/bay for twenty minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.80', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '2.23', 'groupId': 'OG001'}, {'value': '-0.50', 'spread': '1.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at end of 20-minute intervention, up to 120 minutes following randomization', 'description': 'Pain adjectives scale. The minimum score is 1. The maximum score is 7. Higher scores represent worse pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who participated in the music therapy intervention.'}, {'type': 'SECONDARY', 'title': 'Length of Stay in Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Music Therapy Group', 'description': "Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.\n\nMusic Therapy: Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad."}, {'id': 'OG001', 'title': 'Music Listening Group', 'description': 'Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.\n\nMusic Listening: Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Patient receives standard care and waits in treatment room/bay for twenty minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '272.95', 'spread': '72.84', 'groupId': 'OG000'}, {'value': '286.80', 'spread': '116.74', 'groupId': 'OG001'}, {'value': '287.45', 'spread': '119.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of admission into acute care clinic to time of discharge, up to 8 hours.', 'description': 'Length of stay (in minutes) in acute care clinic', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who participated in the music therapy intervention.'}, {'type': 'SECONDARY', 'title': 'Amount of Hydromorphone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Music Therapy Group', 'description': "Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.\n\nMusic Therapy: Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad."}, {'id': 'OG001', 'title': 'Music Listening Group', 'description': 'Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.\n\nMusic Listening: Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Patient receives standard care and waits in treatment room/bay for twenty minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.30', 'spread': '7.84', 'groupId': 'OG000'}, {'value': '8.10', 'spread': '6.70', 'groupId': 'OG001'}, {'value': '10.00', 'spread': '8.25', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of admission into acute care clinic to time of discharge, up to 8 hours.', 'description': 'Amount of Hydromorphone received in acute care clinic following intervention', 'unitOfMeasure': 'milligrams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who participated in the music therapy intervention and received hydromorphone.'}, {'type': 'SECONDARY', 'title': 'Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Music Therapy Group', 'description': "Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.\n\nMusic Therapy: Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad."}, {'id': 'OG001', 'title': 'Music Listening Group', 'description': 'Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.\n\nMusic Listening: Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Patient receives standard care and waits in treatment room/bay for twenty minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.70', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '-2.95', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '-3.10', 'spread': '1.97', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time of admission into acute care clinic to time of discharge, up to 8 hours.', 'description': 'Numeric pain rating between 0-10 before and after admission to acute care clinic. The minimum score is 0. The maximum score is 10. Higher scores represent worse pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who participated in the music therapy intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Music Therapy Group', 'description': "Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.\n\nMusic Therapy: Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad."}, {'id': 'FG001', 'title': 'Music Listening Group', 'description': 'Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.\n\nMusic Listening: Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'Patient receives standard care and waits in treatment room/bay for twenty minutes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': "Following verbal consent on the day of an ACC visit, an RN escorted the participant into the ACC to receive standard care that included vital signs, a lab draw, assessment by a nurse practitioner, and scheduled analgesics. The assigned study condition occurred one hour after participants' first dose of analgesics."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Music Therapy Group', 'description': "Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.\n\nMusic Therapy: Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad."}, {'id': 'BG001', 'title': 'Music Listening Group', 'description': 'Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.\n\nMusic Listening: Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'Patient receives standard care and waits in treatment room/bay for twenty minutes.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.85', 'spread': '9.49', 'groupId': 'BG000'}, {'value': '33.25', 'spread': '11.23', 'groupId': 'BG001'}, {'value': '30.60', 'spread': '7.44', 'groupId': 'BG002'}, {'value': '31.57', 'spread': '9.43', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of Sickle Cell Disease', 'classes': [{'categories': [{'title': 'HbSS', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'HbSC', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'HbSbeta+ Thalassemia', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'HbSbeta0 Thalassemia', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-07', 'studyFirstSubmitDate': '2014-10-10', 'resultsFirstSubmitDate': '2018-11-01', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-02', 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card', 'timeFrame': 'Baseline and at end of 20-minute intervention, up to 120 minutes following randomization', 'description': 'Visual analog scale of pain intensity. The minimum score is 0. The maximum score is 10. Higher scores represent worse pain intensity.'}], 'secondaryOutcomes': [{'measure': 'Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card', 'timeFrame': 'Baseline and at end of 20-minute intervention, up to 120 minutes following randomization', 'description': 'Visual analog scale of Pain Relief. The minimum score is 0. The maximum score is 10. Higher scores represent greater pain relief.'}, {'measure': 'Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card', 'timeFrame': 'Baseline and at end of 20-minute intervention, up to 120 minutes following randomization', 'description': 'Visual analog scale of mood. The minimum score is 0. The maximum score is 10. Higher scores represent better mood.'}, {'measure': 'Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card', 'timeFrame': 'Baseline and at end of 20-minute intervention, up to 120 minutes following randomization', 'description': 'Pain adjectives scale. The minimum score is 1. The maximum score is 7. Higher scores represent worse pain.'}, {'measure': 'Length of Stay in Minutes', 'timeFrame': 'From time of admission into acute care clinic to time of discharge, up to 8 hours.', 'description': 'Length of stay (in minutes) in acute care clinic'}, {'measure': 'Amount of Hydromorphone', 'timeFrame': 'From time of admission into acute care clinic to time of discharge, up to 8 hours.', 'description': 'Amount of Hydromorphone received in acute care clinic following intervention'}, {'measure': 'Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR)', 'timeFrame': 'From time of admission into acute care clinic to time of discharge, up to 8 hours.', 'description': 'Numeric pain rating between 0-10 before and after admission to acute care clinic. The minimum score is 0. The maximum score is 10. Higher scores represent worse pain.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Music Therapy', 'Sickle Cell Disease', 'Pain'], 'conditions': ['Sickle Cell Disease']}, 'referencesModule': {'references': [{'pmid': '22001666', 'type': 'BACKGROUND', 'citation': 'Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to:\n\n1. Investigate the effects of a single 20-minute music therapy intervention with a music therapist on the pain intensity, pain relief, and mood of adult patients with sickle cell disease as compared to:\n\n 1. Adult patients with SCD who listen to their preferred music for 20 minutes without the presence of a music therapist (music listening group)\n 2. Adult patients with SCD who receive standard care alone (control group)\n2. Determine the feasibility (delivery, acceptability, and usefulness) of the music therapy intervention for pain management'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have a diagnosis of sickle cell disease (HbSS, HbSC, HbSbeta+thal, or HbSbeta0thal)\n* 18 years or older\n* Able to speak and understand English\n\nExclusion Criteria:\n\n* Patients who have significant hearing impairments and/or significant visual impairments that have not been corrected'}, 'identificationModule': {'nctId': 'NCT02270060', 'briefTitle': 'Music Therapy in Sickle Cell Pain Mixed Methods Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'The Effects of a Single Music Therapy Session on the Pain of Adult Patients With Sickle Cell Disease: A Mixed Methods Study', 'orgStudyIdInfo': {'id': '08-14-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music Therapy Group', 'description': "Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.", 'interventionNames': ['Other: Music Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Music Listening Group', 'description': 'Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.', 'interventionNames': ['Other: Music Listening']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patient receives standard care and waits in treatment room/bay for twenty minutes.'}], 'interventions': [{'name': 'Music Therapy', 'type': 'OTHER', 'description': "Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.", 'armGroupLabels': ['Music Therapy Group']}, {'name': 'Music Listening', 'type': 'OTHER', 'description': 'Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.', 'armGroupLabels': ['Music Listening Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Seidman Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Samuel N Rodgers-Melnick, MT-BC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kulas Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Music Therapist', 'investigatorFullName': 'Samuel Rodgers-Melnick', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}