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Improving Patient Experience: BMBA

Sponsor
Thomas Jefferson University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05690230
Collaborator
Daisy Foundation (Other)
60
Enrollment
1
Location
4
Arms
6.8
Anticipated Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual reality
  • Other: Environmental changes
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
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.Two interventions will be trialed, each in parallel with a control group. The two phases will be done in sequence.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Improving the Patient Experience During Bone Marrow Biopsy/Aspiration (BMBA): Do Interventions Decrease Distress and Pain
Actual Study Start Date :
Dec 5, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention 1: Virtual reality

Other: Virtual reality
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.
No Intervention: Control 1

Standard of care without change, in parallel with intervention 1: Virtual reality.
Experimental: Intervention 2: Environmental changes

Other: Environmental changes
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.
No Intervention: Control 2

Standard of care without change, in parallel with intervention 2: Environmental changes.

Outcome Measures

Primary Outcome Measures

  1. Distress score [Within 10 minutes pre-procedure]

    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."

  2. Distress score [Within 10 minutes post-procedure]

    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."

Secondary Outcome Measures

  1. Pain intensity [Within 10 minutes pre-procedure]

    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."

  2. Pain intensity [Within 10 minutes post-procedure]

    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."

  3. Patient satisfaction [Within 10 minutes post-procedure]

    To assess patient satisfaction with their procedure. This will be assessed through a patient satisfaction survey including Likert-type questions.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Thomas Jefferson University
  • Daisy Foundation

Investigators

None specified.

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Responsible Party:
Anne Delengowski, Director of Nursing Education, Oncology Clinical Nurse Specialist, Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT05690230
Other Study ID Numbers:
  • 21G.1035
First Posted:
Jan 19, 2023
Last Update Posted:
Jan 19, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Myeloma
Hematologic Neoplasms
Bone Marrow Neoplasms

Study Results

No Results Posted as of Jan 19, 2023