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| ID | Type | Description | Link |
|---|---|---|---|
| ONC-MM-2407 | Other Identifier | Atrium Health | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Atrium Health Levine Cancer Institute | OTHER |
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The purpose of this research study is to see if a virtual reality (VR) headset is useful in reducing physical discomfort and anxiety experienced by patients who are scheduled to undergo a bone marrow biopsy (BMB) and/or bone marrow aspiration (BMA).
This will be a randomized controlled trial comparing standard of care to standard of care + VR intervention for adult participants who have or are suspected of having a malignant hematologic disorder and are scheduled for an outpatient bone marrow biopsy (BMB) and/or bone marrow aspiration (BMA). Participants will be randomized 1:1. Participants will be risk stratified based on whether they are undergoing a biopsy for the first time or not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Other |
| |
| Virtual Reality intervention and Standard of Care | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Other | Standard of care for a bone marrow biopsy/bone marrow aspiration includes routine site-specific lidocaine anesthetic. |
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| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale Pain Scores Immediately Post-biopsy | For each participant, the Numeric Rating Scale (NRS) score immediately post-biopsy will be captured indicating the participants' severity of pain. The score for each participant will be categorized into 6 ordinal categories (0 No Pain, 1-2 Very Mild, 3-4 Mild, 5-6 Moderate, 7-8 Severe, 9-10 Unbearable) and used to assess if those using the Virtual Reality Headset during the procedure experienced less overall pain immediately following the bone marrow biopsy. | Single time point evaluation completed immediately following biopsy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Single time point evaluation completed immediately following biopsy procedure | For each participant, the Numeric Rating Scale (NRS) score 24 hrs (-6 hrs/+12 hrs) post-biopsy will be captured indicating the participants' severity of pain. The score for each participant will be categorized into 6 ordinal categories (0 No Pain, 1-2 Very Mild, 3-4 Mild, 5-6 Moderate, 7-8 Severe, 9-10 Unbearable) and used to assess if those using the Virtual Reality Headset during the procedure experienced less overall persisting pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who discontinued study treatment due to adverse events | Specific to the treatment arm only, a binary variable will be determined for each participant indicating whether or not the subject discontinued use of the virtual reality headset due to adverse events (i.e., headache, neck pain, dizziness, seizures, eye strain or muscle twitching, or syncope). | Evaluation of discontinued study treatment is a periprocedural time point. Estimated time frame is less than 1 hour. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Courtney Schepel | Contact | (980) 442-2327 | Courtney.Schepel@advocatehealth.org | |
| Cindy Varga, MD | Contact | 704-355-2000 | Cindy.Varga@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Cindy Varga, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Insitute | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Virtual Reality intervention | Other | Participants will wear the VR headset (Quest 3 by Meta) during your bone marrow procedure. |
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| Single time point evaluation completed 24 hours after biopsy procedure. |
| State Trait Anxiety Inventory Trait-5 Change Score | The State Trait Anxiety Inventory Trait-5 (STAIT-5) is a five-item assessment scored on a 4-point Likert scale (1-Not at all, 2-Somewhat, 3-Moderately So, 4-Very Much So) that captures the participants' current state of anxiety with higher scores indicating more anxiety. The five items are as follows: I feel upset, I feel frightened, I feel nervous, I am jittery, I feel confused. The total scores can range from 5 to 20 and the reduction and impact on participants' anxiety while using the Virtual Reality Headset will be based on the change from pre and post biopsy assessments. | Two time point evaluations completed immediately following and 24 hours after biopsy procedure. |
| Likelihood to Repeat | The likelihood of the participant being willing to complete a repeat bone marrow biopsy if deemed medically beneficial will be captured on a 5-point Likert scale immediately following the procedure. Participants will be asked to provide their response to: Please rate your agreement with having the bone marrow biopsy/ bone marrow aspirate procedure done again if deemed medically beneficial. Potential responses can be reported as 1-strongly Disagree, 2-Disagree, 3-Neutral/unsure, 4-Agree and 5-Strongly Agree. | Single time point evaluation completed 24 hours after biopsy procedure. |