Hematopoietic and Lymphoid System Neoplasm
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREBone Marrow Aspiration
Undergo bone marrow aspiration/biopsy
PROCEDUREBone Marrow Biopsy
Undergo bone marrow aspiration/biopsy
PROCEDUREMusic Therapy
Listen to music
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented informed consent of the participant and/or legally authorized representative * Willingness to participate in the study * Ability to read English, or willingness to have one of the staff members help with the questionnaire * Age: ≥ 18 years * Hematological conditions requiring a bone marrow biopsy and/or aspiration procedure, regardless of their disease state, and experience with such procedures
Exclusion criteria
* Hearing impairments, and non-verbal communication * Scheduled to undergo a sedated bone marrow biopsy * Scheduled to be premedicated with any anxiolytic or pain medication 30 minutes prior to the procedure * Unwillingness to listen to music * Altered mental health status that would prohibit informed consent and following protocol required instructions * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in anxiety level | Up to 4 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain level | Up to 4 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMonzr M Al Malki
City of Hope Medical Center
Outcome results
None listed