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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03568292
Other study ID # 0S-17-10
Secondary ID NCI-2018-007590S
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date March 1, 2026

Study information

Verified date August 2023
Source University of Southern California
Contact Cheryl Kefauver, RN
Phone 323-865-0459
Email Cheryl.Kefauver@med.usc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 1, 2026
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patient has been diagnosed with any cancer - Patient is currently hospitalized and receiving treatment for a primary or secondary cancer at University of Southern California (USC) Norris Comprehensive Cancer Center and Hospital - Patient is undergoing a bone marrow biopsy or lumbar puncture Exclusion Criteria: - Inability to sign informed assent and/or consent - Patient with an underlying diagnosis of epilepsy, dementia, Parkinson?s disease, primary central nervous system malignancy, brain metastasis, underlying inflammatory or infectious central nervous system disorder, inner ear infection, history of vertigo, baseline visual or hearing impairment, macular degeneration, untreated glaucoma, implantable medical devices or any medical condition that investigator deems contraindicated - Patient with an underlying chronic pain disorder, anxiety disorder, depressive disorder, or other psychiatric illness unspecified - Patient with active Clostridium difficile infection - Patient on any acute (within last < 24 hour [hr]) or chronic pain medication (opioid, nonsteroidal anti-inflammatory drug [NSAID], steroid) - Patient on chronic steroids > 10 mg prednisone equivalent daily or other immunosuppressant > 1 week - Patient who is post bone marrow transplant - Patient with a body mass index (BMI) > 35

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Best Practice
Receive standard of care
Laboratory Biomarker Analysis
Correlative studies
Device:
Oculus Rift Headset
Subject wears headset for virtual reality intervention during bone marrow biopsy or lumbar puncture procedure
Other:
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States USC / Norris Comprehensive Cancer Center Los Angeles California

Sponsors (3)

Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI), Virtually Strong, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Anxiety Will be assessed by the State-Trait Anxiety Inventory. Up to 1 year
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