Los Angeles, California 90033

  • Malignant Neoplasm

Purpose:

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.


Study summary:

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).


Criteria:

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


NCT ID:

NCT03568292


Primary Contact:

Principal Investigator
Jacek Pinski, MD
University of Southern California

Zeno Ashai
Phone: 323-865-0463
Email: zeno.ashai@med.usc.edu


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90033
United States

Jacek Pinski
Phone: 323-865-3929
Email: pinski_j@ccnt.usc.edu

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 16, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.