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Trial Title:
Improving Patient Experience: BMBA
NCT ID:
NCT05690230
Condition:
Bone Marrow Cancer
Leukemia
Lymphoma
Multiple Myeloma
Hematologic Cancer
Conditions: Official terms:
Multiple Myeloma
Hematologic Neoplasms
Bone Marrow Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Virtual reality
Description:
Patients will be provided with a wireless virtual reality headset that contains a guided
meditation application. The application allows users to select their preferred music,
visual setting, and a topic for meditation.
Arm group label:
Intervention 1: Virtual reality
Intervention type:
Other
Intervention name:
Environmental changes
Description:
A nature themed wall mural decal will be installed in the procedure room and the in-room
computer will play music from Pandora. A selection of suggested stations will be
provided, with the option for outside selections.
Arm group label:
Intervention 2: Environmental changes
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Thomas Jefferson University Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Start date:
December 5, 2022
Completion date:
April 28, 2024
Lead sponsor:
Agency:
Thomas Jefferson University
Agency class:
Other
Collaborator:
Agency:
Daisy Foundation
Agency class:
Other
Source:
Thomas Jefferson University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05690230
https://www.nccn.org/docs/default-source/patient-resources/nccn_distress_thermometer.pdf?sfvrsn=ef1df1a2_4
https://www.meta.com/legal/quest/health-and-safety-warnings/
