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OpenTrials
Completed

NCT Number: NCT05690230

Improving Patient Experience: BMBA

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.

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Key information

Conditions

Bone Marrow Cancer Blood Protein Disorders Bone Marrow Diseases Bone Marrow Neoplasms Cardiovascular Diseases Hematologic Cancer Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality

Other

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.

Environmental changes

Other

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.

Primary outcomes

  1. Distress score

    Time frame: 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

    Time frame: 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 outcomes

  1. Pain intensity

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Daisy Foundation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2023
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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