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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00759 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 0S-17-10 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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Awaiting new cohort to open
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Virtually Strong, LLC | UNKNOWN |
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This trial studies how well virtual reality (VR) works in reducing pain and anxiety in cancer participants undergoing bone marrow biopsy or lumbar puncture. Virtual reality may impact pain and anxiety during and after the procedure.
PRIMARY OBJECTIVES:
I. To determine the feasibility of VR in patients undergoing procedural intervention.
SECONDARY OBJECTIVES:
I. To estimate differences between the two arms in terms of pain and anxiety. II. To document any adverse events that could possibly be attributed to the VR intervention.
EXPLORATORY OBJECTIVES:
I. Explore the use of biomarkers as a tool to reflect the impact of intervention.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants undergo VR intervention peri-procedure (bone marrow biopsy or lumbar puncture) lasting until completion of the procedure.
ARM II: Participants receive standard of care during procedure (bone marrow biopsy or lumbar puncture).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I: Virtual Reality | Experimental | Participants receive the VR intervention during bone marrow biopsy or lumbar puncture lasting until completion of the procedure. Participants will be trained to use VR equipment prior to the bone marrow biopsy or lumbar puncture. The headset will cover both eyes with a strap along the back to hold the headset in place. The headset will be attached by a wire to a laptop which will power the headset and provide content. A remote control will be available for assistance in setting up or stopping the content in the case of an event. The VR content will consist of meditation and relaxing techniques through visual and auditory input which can last up to one hour. There will be minimal stimulatory effort to decrease excess movement for the procedure. |
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| Arm II: No Virtual Reality | Active Comparator | Participants receive standard of care during bone marrow biopsy or lumbar puncture. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard of care |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain as assessed according to a visual analog scale (VAS) | A visual analogue pain scale is a validated pain measure. A 10 centimeter horizontal line with a 0 (no pain) on the far left and 10 (worst possible pain) on the far right. Participants rate pain intensity by drawing a mark on the line. Pain intensity is obtained by measuring from the 0 to the participant's mark on the line, yielding a score from 0 to 10. | Up to 1 year |
| Anxiety | Will be assessed by the State-Trait Anxiety Inventory. | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacek Pinski, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Oculus Rift Headset | Device | Subject wears headset for virtual reality intervention during bone marrow biopsy or lumbar puncture procedure |
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| Questionnaire Administration | Other | Ancillary studies |
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| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |