Clinical trial NCT05690230: Improving Patient Experience: BMBA
Official title: Improving the Patient Experience During Bone Marrow Biopsy/Aspiration (BMBA): Do Interventions Decrease Distress and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Marrow Cancer
Leukemia
Lymphoma
Multiple Myeloma
Hematologic Cancer
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Daisy Foundation
First posted: 2023-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two interventions will be trialed, each in parallel with a control group. The two phases will be done in sequence.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study seeks to determine if patients undergoing a bone marrow biopsy/aspiration (BMBA) procedure who receive distraction techniques have lower levels of distress and pain, and higher post-procedure satisfaction, compared to those receiving standard-of-care. Intervention 1 is guided meditation in a virtual reality (VR) headset. Intervention 2 is comprised of environmental changes to the room (via nature-themed decals) and music.

Detailed description: This study seeks to determine if patients undergoing a bone marrow biopsy/aspiration (BMBA) procedure who receive distraction techniques have lower levels of distress and pain, and higher post-procedure satisfaction, compared to those receiving standard-of-care. Intervention 1 is guided meditation in a virtual reality (VR) headset. Intervention 2 is comprised of environmental changes to the room (via nature-themed decals) and music.

Eligibility criteria: Inclusion Criteria:

* Provide signed and dated informed consent form
* Willing to comply with all study procedures
* Over 18 years of age
* Prior history of at least 1 (one) BMBA at Jefferson outpatient oncology office within the past 2 (two) years
* Visiting the Jefferson outpatient oncology office for a BMBA procedure during the study duration

Exclusion Criteria:

* Inability to read questions in English
* Inability to answer questions autonomously
* History of vertigo
* Legal blindness in both eyes
* Severe or profound hearing loss, or deafness

Primary outcomes:
measure: Distress score
timeFrame: Within 10 minutes pre-procedure
measure: Distress score
timeFrame: Within 10 minutes post-procedure
Secondary outcomes:
measure: Pain intensity
timeFrame: Within 10 minutes pre-procedure
measure: Pain intensity
timeFrame: Within 10 minutes post-procedure
measure: Patient satisfaction
timeFrame: Within 10 minutes post-procedure
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
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