Improving Patient Experience: BMBA

NCT05690230 | Completed

• 2 other identifiers: 21G.1035JT 18448
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Marrow Cancer; Leukemia; Lymphoma; Multiple Myeloma; Hematologic Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pain intensity

  Within 10 minutes pre-procedure

• Pain intensity

  Within 10 minutes post-procedure

• Patient satisfaction

  Within 10 minutes post-procedure

Study Arms (4)

Intervention 1: Virtual reality

EXPERIMENTAL

Other: Virtual reality

Control 1

NO INTERVENTION

Standard of care without change, in parallel with intervention 1: Virtual reality.

Intervention 2: Environmental changes

EXPERIMENTAL

Other: Environmental changes

Control 2

NO INTERVENTION

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

Interventions

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.

Intervention 1: Virtual reality

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.

Intervention 2: Environmental changes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Daisy Foundation: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (28)

• Schweitzer M, Gilpin L, Frampton S. Healing spaces: elements of environmental design that make an impact on health. J Altern Complement Med. 2004;10 Suppl 1:S71-83. doi: 10.1089/1075553042245953.

  PMID: 15630824 BACKGROUND

• Watts G, Khan A, Pheasant R. Influence of soundscape and interior design on anxiety and perceived tranquillity of patients in a healthcare setting. Applied Acoustics. 2016 Mar; 104:135-41.

  BACKGROUND

• Ulrich RS. Effects of interior design on wellness: theory and recent scientific research. J Health Care Inter Des. 1991;3:97-109.

  PMID: 10123973 BACKGROUND

• Laursen J, Danielsen A, Rosenberg J. Effects of environmental design on patient outcome: a systematic review. HERD. 2014 Summer;7(4):108-19. doi: 10.1177/193758671400700410.

  PMID: 25303431 BACKGROUND

• Diette GB, Lechtzin N, Haponik E, Devrotes A, Rubin HR. Distraction therapy with nature sights and sounds reduces pain during flexible bronchoscopy: a complementary approach to routine analgesia. Chest. 2003 Mar;123(3):941-8. doi: 10.1378/chest.123.3.941.

  PMID: 12628899 BACKGROUND

• Iyendo TO, Uwajeh PC, Ikenna ES. The therapeutic impacts of environmental design interventions on wellness in clinical settings: A narrative review. Complement Ther Clin Pract. 2016 Aug;24:174-88. doi: 10.1016/j.ctcp.2016.06.008. Epub 2016 Jul 1.

  PMID: 27502819 BACKGROUND

• Tsai HF, Chen YR, Chung MH, Liao YM, Chi MJ, Chang CC, Chou KR. Effectiveness of music intervention in ameliorating cancer patients' anxiety, depression, pain, and fatigue: a meta-analysis. Cancer Nurs. 2014 Nov-Dec;37(6):E35-50. doi: 10.1097/NCC.0000000000000116.

  PMID: 24662723 BACKGROUND

• Danhauer SC, Vishnevsky T, Campbell CR, McCoy TP, Tooze JA, Kanipe KN, Arrington SA, Holland EK, Lynch MB, Hurd DD, Cruz J. Music for patients with hematological malignancies undergoing bone marrow biopsy: a randomized controlled study of anxiety, perceived pain, and patient satisfaction. J Soc Integr Oncol. 2010;8(4):140-147.

  PMID: 24619452 BACKGROUND

• Thoma MV, Zemp M, Kreienbuhl L, Hofer D, Schmidlin PR, Attin T, Ehlert U, Nater UM. Effects of Music Listening on Pre-treatment Anxiety and Stress Levels in a Dental Hygiene Recall Population. Int J Behav Med. 2015 Aug;22(4):498-505. doi: 10.1007/s12529-014-9439-x.

  PMID: 25200448 BACKGROUND

• Daniel E. Music used as anti-anxiety intervention for patients during outpatient procedures: A review of the literature. Complement Ther Clin Pract. 2016 Feb;22:21-3. doi: 10.1016/j.ctcp.2015.11.007. Epub 2015 Dec 1.

  PMID: 26850800 BACKGROUND

• Speca M, Carlson LE, Goodey E, Angen M. A randomized, wait-list controlled clinical trial: the effect of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients. Psychosom Med. 2000 Sep-Oct;62(5):613-22. doi: 10.1097/00006842-200009000-00004.

  PMID: 11020090 BACKGROUND

• Deng G, Cassileth BR. Integrative oncology: complementary therapies for pain, anxiety, and mood disturbance. CA Cancer J Clin. 2005 Mar-Apr;55(2):109-16. doi: 10.3322/canjclin.55.2.109.

  PMID: 15761079 BACKGROUND

• Sander Wint S, Eshelman D, Steele J, Guzzetta CE. Effects of distraction using virtual reality glasses during lumbar punctures in adolescents with cancer. Oncol Nurs Forum. 2002 Jan-Feb;29(1):E8-E15. doi: 10.1188/02.ONF.E8-E15.

  PMID: 11845217 BACKGROUND

• Espinoza M, Banos RM, Garcia-Palacios A, Cervera JM, Esquerdo G, Barrajon E, Botella C. Promotion of emotional wellbeing in oncology inpatients using VR. Stud Health Technol Inform. 2012;181:53-7.

  PMID: 22954828 BACKGROUND

• Wiederhold BK, Gao K, Sulea C, Wiederhold MD. Virtual reality as a distraction technique in chronic pain patients. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):346-52. doi: 10.1089/cyber.2014.0207.

  PMID: 24892196 BACKGROUND

• Bekelis K, Calnan D, Simmons N, MacKenzie TA, Kakoulides G. Effect of an Immersive Preoperative Virtual Reality Experience on Patient Reported Outcomes: A Randomized Controlled Trial. Ann Surg. 2017 Jun;265(6):1068-1073. doi: 10.1097/SLA.0000000000002094.

  PMID: 27906757 BACKGROUND

• Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599.

  PMID: 29485536 BACKGROUND

• Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.

  PMID: 28356241 BACKGROUND

• Nanda U, Chanaud C, Nelson M, Zhu X, Bajema R, Jansen BH. Impact of visual art on patient behavior in the emergency department waiting room. J Emerg Med. 2012 Jul;43(1):172-81. doi: 10.1016/j.jemermed.2011.06.138. Epub 2012 Feb 9.

  PMID: 22325555 BACKGROUND

• Harte R, Glynn L, Rodriguez-Molinero A, Baker PM, Scharf T, Quinlan LR, OLaighin G. A Human-Centered Design Methodology to Enhance the Usability, Human Factors, and User Experience of Connected Health Systems: A Three-Phase Methodology. JMIR Hum Factors. 2017 Mar 16;4(1):e8. doi: 10.2196/humanfactors.5443.

  PMID: 28302594 BACKGROUND

• Devlin AS, Andrade CC, Carvalho D. Qualities of Inpatient Hospital Rooms: Patients' Perspectives. HERD. 2016 Apr;9(3):190-211. doi: 10.1177/1937586715607052. Epub 2015 Dec 14.

  PMID: 26666814 BACKGROUND

• Satija A, Bhatnagar S. Complementary Therapies for Symptom Management in Cancer Patients. Indian J Palliat Care. 2017 Oct-Dec;23(4):468-479. doi: 10.4103/IJPC.IJPC_100_17.

  PMID: 29123357 BACKGROUND

• Bani Mohammad E, Ahmad M. Virtual reality as a distraction technique for pain and anxiety among patients with breast cancer: A randomized control trial. Palliat Support Care. 2019 Feb;17(1):29-34. doi: 10.1017/S1478951518000639. Epub 2018 Sep 10.

  PMID: 30198451 BACKGROUND

• Stevenson MP, Schilhab T, Bentsen P. Attention Restoration Theory II: a systematic review to clarify attention processes affected by exposure to natural environments. J Toxicol Environ Health B Crit Rev. 2018;21(4):227-268. doi: 10.1080/10937404.2018.1505571. Epub 2018 Aug 21.

  PMID: 30130463 BACKGROUND

• Hartig T, Mang M, Evans GW. Restorative effects of natural environment experiences. Environ Behav. 1991;23:3-26.

  BACKGROUND

• Li Y, Xing X, Shi X, Yan P, Chen Y, Li M, Zhang W, Li X, Yang K. The effectiveness of music therapy for patients with cancer: A systematic review and meta-analysis. J Adv Nurs. 2020 May;76(5):1111-1123. doi: 10.1111/jan.14313. Epub 2020 Feb 19.

  PMID: 32017183 BACKGROUND

• Krishnaswamy P, Nair S. Effect of Music Therapy on Pain and Anxiety Levels of Cancer Patients: A Pilot Study. Indian J Palliat Care. 2016 Jul-Sep;22(3):307-11. doi: 10.4103/0973-1075.185042.

  PMID: 27559260 BACKGROUND

• Lewis CH, Griffin MJ. Human factors consideration in clinical applications of virtual reality. Stud Health Technol Inform. 1997;44:35-56.

  PMID: 10175342 BACKGROUND

Related Links

• NCCN Distress Thermometer and Problem List for Patients
• Oculus Go warnings

MeSH Terms

Conditions

Bone Marrow Neoplasms; Leukemia; Lymphoma; Multiple Myeloma; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two interventions will be trialed, each in parallel with a control group. The two phases will be done in sequence.

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 19, 2023
• Study Start: December 5, 2022
• Primary Completion: January 29, 2024
• Study Completion: June 5, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)