Multiple Myeloma Clinical Trial
Official title:
Improving the Patient Experience During Bone Marrow Biopsy/Aspiration (BMBA): Do Interventions Decrease Distress and Pain
Verified date | March 2024 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | April 28, 2024 |
Est. primary completion date | March 29, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University | Daisy Foundation |
United States,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Distress score | The primary outcome will be reported on a scale of 0-10, based on the National Comprehensive Cancer Network (NCCN) Distress Thermometer, 0 signifying "no distress" and 10 signifying "extreme distress." This scale is standardly used with oncology patients to determine their distress levels-distress refers to "an unpleasant experience of a mental, physical, social, or spiritual nature. It can affect the way you think, feel, or act. Distress may make it harder to cope with having cancer, its symptoms, or its treatment." | Within 10 minutes pre-procedure | |
Primary | Distress score | The primary outcome will be reported on a scale of 0-10, based on the National Comprehensive Cancer Network (NCCN) Distress Thermometer, 0 signifying "no distress" and 10 signifying "extreme distress." This scale is standardly used with oncology patients to determine their distress levels-distress refers to "an unpleasant experience of a mental, physical, social, or spiritual nature. It can affect the way you think, feel, or act. Distress may make it harder to cope with having cancer, its symptoms, or its treatment." | Within 10 minutes post-procedure | |
Secondary | Pain intensity | To assess patient pain scores related to their BMBA procedure. This will be measured through the 0-10 Numeric Pain Intensity Scale, 0 signifying "no pain" and 10 signifying "the worst pain imaginable." | Within 10 minutes pre-procedure | |
Secondary | Pain intensity | To assess patient pain scores related to their BMBA procedure. This will be measured through the 0-10 Numeric Pain Intensity Scale, 0 signifying "no pain" and 10 signifying "the worst pain imaginable." | Within 10 minutes post-procedure | |
Secondary | Patient satisfaction | To assess patient satisfaction with their procedure. This will be assessed through a patient satisfaction survey including Likert-type questions. | Within 10 minutes post-procedure |
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