Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-06 @ 6:49 AM
Study NCT ID:
NCT05676151
Status:
COMPLETED
Last Update Posted:
2024-07-19
First Post:
2023-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Music Therapy in Pain Rehabilitation Programs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2023-01-04', 'studyFirstSubmitQcDate': '2023-01-06', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mood', 'timeFrame': 'Baseline, after music intervention approximately 20 minutes', 'description': 'We will use the NCCN distress thermometer before and after the creative work intervention to assess distress. For those patients who indicate high feelings of depression, their mood would be dealt with in accordance with clinic practice.\n\nThe Distress Thermometer measures distress on a 0 to 10 scale. To report your distress, circle the number that matches your level of distress in the past week. The Problem List includes problems from 5 areas of life: practical, family, emotional, spiritual/religious, and physical problems. The higher the score the more distress experienced in that domain.'}, {'measure': 'Change in pain level', 'timeFrame': 'Baseline, after music intervention approximately 20 minutes', 'description': 'A 0-10 Likert Pain scale will be used. 0 = No Pain, 10 = Worst Pain Imaginable'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Music Therapy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure changes in mood, symptom burden, pain level, and stress scores in patients before and after a 20-minute music therapy intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age\n* Patients that are enrolled in the Pain Rehabilitation Center, Mayo Florida\n\nExclusion Criteria:\n\n\\- ≤ 18 years of age.'}, 'identificationModule': {'nctId': 'NCT05676151', 'briefTitle': 'Study of Music Therapy in Pain Rehabilitation Programs', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'How Efficient is Music Therapy as a Distraction Technique in the Pain Rehabilitation Program Patients', 'orgStudyIdInfo': {'id': '22-003694'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music Therapy in Pain Rehabilitation', 'description': 'Subjects undergoing care at the Mayo Clinic Florida Pain Rehabilitation Center (PRC) to address pain will receive a 20-minute music therapy intervention', 'interventionNames': ['Behavioral: Music Therapy']}], 'interventions': [{'name': 'Music Therapy', 'type': 'BEHAVIORAL', 'description': '20-minute music-therapy-informed interventions (musical bingo, songwriting, lyric scramble) guided by a music therapist', 'armGroupLabels': ['Music Therapy in Pain Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Christopher Sletten, PhD, LP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christopher D. Sletten', 'investigatorAffiliation': 'Mayo Clinic'}}}}