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Virtual Reality in Reducing Pain and Anxiety in Cancer Participants Undergoing Painful Procedures

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ClinicalTrials.gov Identifier: NCT03568292
Recruitment Status : Not yet recruiting
First Posted : June 26, 2018
Last Update Posted : April 5, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Virtually Strong, LLC
Information provided by (Responsible Party):
University of Southern California

Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Other: Best Practice Other: Laboratory Biomarker Analysis Device: Oculus Rift Headset Other: Questionnaire Administration Not Applicable

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Virtual Reality on Pain and Anxiety in Cancer Patients Undergoing Painful Procedures
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Arm I: Virtual Reality
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.
Other: 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

Active Comparator: Arm II: No Virtual Reality
Participants receive standard of care during bone marrow biopsy or lumbar puncture.
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Pain as assessed according to a visual analog scale (VAS) [ Time Frame: Up to 1 year ]
    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.

  2. Anxiety [ Time Frame: Up to 1 year ]
    Will be assessed by the State-Trait Anxiety Inventory.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568292


Contacts
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Contact: Zeno Ashai 323-865-0463 zeno.ashai@med.usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Contact: Jacek Pinski    323-865-3929    pinski_j@ccnt.usc.edu   
Principal Investigator: Jacek Pinski         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Virtually Strong, LLC
Investigators
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Principal Investigator: Jacek Pinski, MD University of Southern California
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03568292    
Other Study ID Numbers: 0S-17-10
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 )
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms