Improving Patient Experience: BMBA

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving the Patient Experience During Bone Marrow Biopsy/Aspiration (BMBA): Do Interventions Decrease Distress and Pain

Conditions
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Bone Marrow Cancer, Leukemia, Lymphoma, Multiple Myeloma, Hematologic Cancer

Intervention / Treatment
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* Other: Virtual reality
* Other: Environmental changes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two interventions will be trialed, each in parallel with a control group. The two phases will be done in sequence.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention 1: Virtual reality<br> | Other: Virtual reality<br>* 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.<br>|
| No Intervention: Control 1<br>Standard of care without change, in parallel with intervention 1: Virtual reality. | |
| Experimental: Intervention 2: Environmental changes<br> | Other: Environmental changes<br>* 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.<br>|
| No Intervention: Control 2<br>Standard of care without change, in parallel with intervention 2: Environmental changes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |