Bone Marrow CancerNCT05690230

Improving Patient Experience: BMBA

A study testing Virtual reality and Environmental changes in people with Bone Marrow Cancer and Leukemia, run by Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Bone Marrow Cancer, Leukemia, Lymphoma
What is being tested?: Virtual reality and Environmental changes
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 5 Dec 2022to 5 Jun 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

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

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.

Read the detailed description

Conditions: Bone Marrow Cancer, Leukemia, Lymphoma, Multiple Myeloma, Hematologic Cancer
Being tested: Virtual reality, Environmental changes
Medical subject headings: Bone Marrow Neoplasms, Leukemia, Lymphoma, Multiple Myeloma, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual realityOther
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 changesOther
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.

Study groups in NCT05690230
Study group	Role	What they receive
Intervention 1: Virtual reality	Experimental	Not described Receives: Other: Virtual reality
Control 1	No intervention	Standard of care without change, in parallel with intervention 1: Virtual reality.
Intervention 2: Environmental changes	Experimental	Not described Receives: Other: Environmental changes
Control 2	No intervention	Standard of care without change, in parallel with intervention 2: Environmental changes.

What is being measured

The primary outcome is the main question the study is designed to answer.

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."
Measured: 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."
Measured: Within 10 minutes post-procedure

Secondary outcomes (3)

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."
Measured: 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."
Measured: 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.
Measured: Within 10 minutes post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Dec 20225 Jun 2024

First posted19 Jan 2023
Study start5 Dec 2022
Primary completion29 Jan 2024
Study completion5 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Bone Marrow CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05690230
Sponsor's protocol ID: 21G.1035
Other IDs: JT 18448
Status last verified: Apr 2025
First submitted: 21 Dec 2022
Last updated: 24 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 15630824
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.
Ulrich RS. Effects of interior design on wellness: theory and recent scientific research. J Health Care Inter Des. 1991;3:97-109.
PubMed 10123973
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.
PubMed 25303431
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.
PubMed 12628899
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.
PubMed 27502819
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.
PubMed 24662723
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.
PubMed 24619452
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.
PubMed 25200448
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.
PubMed 26850800
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.
PubMed 11020090
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.
PubMed 15761079
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.
PubMed 11845217
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.
PubMed 22954828
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.
PubMed 24892196

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving the Patient Experience During Bone Marrow Biopsy/Aspiration (BMBA): Do Interventions Decrease Distress and Pain
ClinicalTrials.gov ID: NCT05690230
Acronym / sponsor ID: 21G.1035
Conditions: Bone Marrow Cancer, Leukemia, Lymphoma, Multiple Myeloma, Hematologic Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Thomas Jefferson UniversityUniversity, hospital or other
Collaborators: Daisy Foundation
Study start: 5 Dec 2022 (actual)
Primary completion: 29 Jan 2024 (actual)
Study completion: 5 Jun 2024 (actual)
First posted: 19 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: Two interventions will be trialed, each in parallel with a control group. The two phases will be done in sequence.

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Virtual realityPatients 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.	Other	Intervention 1: Virtual reality
Environmental changesA 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.	Other	Intervention 2: Environmental changes

Primary outcome

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."
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."

3 secondary outcomes

Pain intensity
Time frame: Within 10 minutes pre-procedure
Pain intensity
Time frame: Within 10 minutes post-procedure
Patient satisfaction
Time frame: Within 10 minutes post-procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
Background: PubMed 15630824Schweitzer 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.
BackgroundWatts 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: PubMed 10123973Ulrich RS. Effects of interior design on wellness: theory and recent scientific research. J Health Care Inter Des. 1991;3:97-109.
Background: PubMed 25303431Laursen 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.
Background: PubMed 12628899Diette 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.
Background: PubMed 27502819Iyendo 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.
Background: PubMed 24662723Tsai 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.
Background: PubMed 24619452Danhauer 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.
Background: PubMed 25200448Thoma 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.
Background: PubMed 26850800Daniel 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.
Background: PubMed 11020090Speca 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.
Background: PubMed 15761079Deng 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.
NCCN Distress Thermometer and Problem List for PatientsLink provided by the sponsor.
Oculus Go warningsLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality and Environmental changes in people with Bone Marrow Cancer and Leukemia, run by Thomas Jefferson University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distress score (time frame: Within 10 minutes pre-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05690230, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.