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| ID | Type | Description | Link |
|---|---|---|---|
| JT 18448 | Other Identifier | JeffTrial Number |
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| Name | Class |
|---|---|
| Daisy Foundation | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention 1: Virtual reality | Experimental |
| |
| Control 1 | No Intervention | Standard of care without change, in parallel with intervention 1: Virtual reality. | |
| Intervention 2: Environmental changes | Experimental |
| |
| Control 2 | No Intervention | Standard of care without change, in parallel with intervention 2: Environmental changes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pain intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15630824 | Background | 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. | |
| 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. | ||
| 10123973 |
| Label | URL |
|---|---|
| NCCN Distress Thermometer and Problem List for Patients | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2021 | Dec 3, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 10, 2022 | Dec 3, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019046 | Bone Marrow Neoplasms |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
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Two interventions will be trialed, each in parallel with a control group. The two phases will be done in sequence.
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| 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. |
|
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 |
| 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 |
| Background |
| Ulrich RS. Effects of interior design on wellness: theory and recent scientific research. J Health Care Inter Des. 1991;3:97-109. |
| 25303431 | 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. |
| 12628899 | 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. |
| 27502819 | 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. |
| 24662723 | 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. |
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| Oculus Go warnings | View source |
| D006425 |
| Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |