Improving Patient Experience: BMBA

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05690230
• Other study ID #: 21G.1035
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 5, 2022
• Est. completion date: April 28, 2024

Study information

• Verified date: March 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bone Marrow Cancer
• Bone Marrow Neoplasms
• Hematologic Cancer
• Hematologic Neoplasms
• Leukemia
• Lymphoma
• Multiple Myeloma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Daisy Foundation

Country where clinical trial is conducted

United States, 

References & Publications (28)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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.

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. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

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

External Links

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