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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-09975 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 22502 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVE:
I. 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.
SECONDARY OBJECTIVE:
I. To determine if patients with lower to no anxiety during bone marrow aspiration and/or biopsy will also experience less pain.
EXPLORATORY OBJECTIVE:
I. To design and implement an evidence-based music intervention protocol that could be used during bone marrow aspiration and/or biopsy.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo standard of care bone marrow biopsy and/or aspiration.
GROUP II: Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (no music) | Active Comparator | Patients undergo standard of care bone marrow biopsy and/or aspiration. |
|
| Group II (listen to music) | Experimental | Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Marrow Aspiration | Procedure | Undergo bone marrow aspiration/biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in anxiety level | 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 | Up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain level | 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. | Up to 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monzr M Al Malki | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| Bone Marrow Biopsy | Procedure | Undergo bone marrow aspiration/biopsy |
|
|
| Music Therapy | Procedure | Listen to music |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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