Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2026-01-07 @ 8:34 PM
Study NCT ID:
NCT06169267
Status:
RECRUITING
Last Update Posted:
2025-07-04
First Post:
2023-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Passive Music Intervention for the Reduction of Anxiety in Patients Undergoing Bone Marrow Aspiration and/or Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2023-12-05', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in anxiety level', 'timeFrame': 'Up to 4 months', 'description': 'Measured by State-Trait Anxiety Inventory (STAI) based on the response to 20 anxiety state-related questions, each scaled between 1 and 4, from low to high anxiety'}], 'secondaryOutcomes': [{'measure': 'Pain level', 'timeFrame': 'Up to 4 months', 'description': 'The visual analog scale ranging from 0 to 10 will be used to rate the pain level by subjects: 1-3 as mild, 4-6 as moderate and 7-10 as severe. The pain level will be compared between the music and non-music group by two-sample t tests. Univariate and multivariate analysis on pain level will be similar as that for anxiety.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphoid System Neoplasm']}, 'descriptionModule': {'briefSummary': 'This phase III trial compares the effect of adding passive music when undergoing bone marrow biopsy/aspirate versus bone marrow biopsy/aspirate alone in reducing anxiety. Music therapy helps relieve pain or stress and promote well-being. Listening to music during a bone marrow biopsy/aspirate procedure may reduce anxiety during the procedure.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine whether music listening alleviates psychological distress such as anxiety in patients undergoing bone marrow aspiration and/or biopsy that do not require general anesthesia.\n\nSECONDARY OBJECTIVE:\n\nI. To determine if patients with lower to no anxiety during bone marrow aspiration and/or biopsy will also experience less pain.\n\nEXPLORATORY OBJECTIVE:\n\nI. To design and implement an evidence-based music intervention protocol that could be used during bone marrow aspiration and/or biopsy.\n\nOUTLINE: Patients are randomized to 1 of 2 groups.\n\nGROUP I: Patients undergo standard of care bone marrow biopsy and/or aspiration.\n\nGROUP II: Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented informed consent of the participant and/or legally authorized representative\n* Willingness to participate in the study\n* Ability to read English, or willingness to have one of the staff members help with the questionnaire\n* Age: ≥ 18 years\n* Hematological conditions requiring a bone marrow biopsy and/or aspiration procedure, regardless of their disease state, and experience with such procedures\n\nExclusion Criteria:\n\n* Hearing impairments, and non-verbal communication\n* Scheduled to undergo a sedated bone marrow biopsy\n* Scheduled to be premedicated with any anxiolytic or pain medication 30 minutes prior to the procedure\n* Unwillingness to listen to music\n* Altered mental health status that would prohibit informed consent and following protocol required instructions\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)'}, 'identificationModule': {'nctId': 'NCT06169267', 'briefTitle': 'Passive Music Intervention for the Reduction of Anxiety in Patients Undergoing Bone Marrow Aspiration and/or Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Phase III Intention to Treat Study of the Effect of Passive Music Intervention on Anxiety in Patients Undergoing Bone Marrow Aspiration and/or Biopsy', 'orgStudyIdInfo': {'id': '22502'}, 'secondaryIdInfos': [{'id': 'NCI-2023-09975', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '22502', 'type': 'OTHER', 'domain': 'City of Hope Medical Center'}, {'id': 'P30CA033572', 'link': 'https://reporter.nih.gov/quickSearch/P30CA033572', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I (no music)', 'description': 'Patients undergo standard of care bone marrow biopsy and/or aspiration.', 'interventionNames': ['Procedure: Bone Marrow Aspiration', 'Procedure: Bone Marrow Biopsy', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Group II (listen to music)', 'description': 'Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration.', 'interventionNames': ['Procedure: Bone Marrow Aspiration', 'Procedure: Bone Marrow Biopsy', 'Procedure: Music Therapy', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Bone Marrow Aspiration', 'type': 'PROCEDURE', 'description': 'Undergo bone marrow aspiration/biopsy', 'armGroupLabels': ['Group I (no music)', 'Group II (listen to music)']}, {'name': 'Bone Marrow Biopsy', 'type': 'PROCEDURE', 'otherNames': ['Biopsy of Bone Marrow', 'Biopsy, Bone Marrow'], 'description': 'Undergo bone marrow aspiration/biopsy', 'armGroupLabels': ['Group I (no music)', 'Group II (listen to music)']}, {'name': 'Music Therapy', 'type': 'PROCEDURE', 'description': 'Listen to music', 'armGroupLabels': ['Group II (listen to music)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (no music)', 'Group II (listen to music)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Monzr M. Al Malki', 'role': 'CONTACT', 'email': 'malmalki@coh.org', 'phone': '626-218-2405'}, {'name': 'Monzr M. Al Malki', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Monzr M Al Malki', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}