Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-02-21 @ 8:39 AM
Study NCT ID:
NCT02150395
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2014-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Music Therapy on Anxiety in Patients With Cancer Undergoing Simulation for Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-28', 'studyFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2014-05-28', 'lastUpdatePostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in state anxiety', 'timeFrame': '20 minutes', 'description': 'pt received a protocolized music therapy intervention that included altered state induction, music driven guided visualiztion, and psychoeducation on relaxation techniques to be used during simulation for radiation therapy. Prescribed pre-recorded music program provided to be used during simulation.'}], 'secondaryOutcomes': [{'measure': 'reduced distress', 'timeFrame': '20 minutes', 'description': 'pt received a protocolized music therapy intervention that included altered state induction, music driven guided visualiztion, and psychoeducation on relaxation techniques to be used during simulation for radiation therapy. Prescribed pre-recorded music program provided to be used during simulation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anxiety and Distress']}, 'descriptionModule': {'briefSummary': 'This study looks at the effects of a protocolized music therapy intervention on state anxiety for patients with cancer undergoing simulation for radiation therapy. Simulation, which is an imaging and diagnostic procedure, has been identified as producing significantly high levels of anxiety in many cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed patients with breast cancer, and newly diagnosed patients with head and neck cancer.\n* 18 or over.\n* Fluent in English.\n\nExclusion Criteria:\n\n* Under 18 years.\n* Pre-existing anxiety disorders.'}, 'identificationModule': {'nctId': 'NCT02150395', 'briefTitle': 'Impact of Music Therapy on Anxiety in Patients With Cancer Undergoing Simulation for Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Medical Center'}, 'officialTitle': 'The Impact of Music Therapy on Anxiety in Patients Newly Diagnosed With Cancer & Undergoing Simulation for Radiation Therapy', 'orgStudyIdInfo': {'id': 'IRB 199-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'music therapy', 'description': 'pt received a protocolized music therapy intervention that included altered state induction, music driven guided visualiztion, and psychoeducation on relaxation techniques to be used during simulation for radiation therapy. Prescribed pre-recorded music program provided to be used during simulation.', 'interventionNames': ['Other: music therapy']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'no intervention'}], 'interventions': [{'name': 'music therapy', 'type': 'OTHER', 'armGroupLabels': ['music therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Joanne V Loewy, DA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}