City of Hope Medical Center
Duarte, California, 91010, United States
NCT Number: NCT06169267
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 3
Duarte, California, 91010, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo bone marrow aspiration/biopsy
Undergo bone marrow aspiration/biopsy
Other names: Biopsy of Bone Marrow, Biopsy, Bone Marrow
Listen to music
Ancillary studies
Time frame: 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
Time frame: 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.
City of Hope Medical Center
Other
Phase III Intention to Treat Study of the Effect of Passive Music Intervention on Anxiety in Patients Undergoing Bone Marrow Aspiration and/or Biopsy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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