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

NCT03568292 | Suspended DMC FDA Device

• 3 other identifiers: 0S-17-10NCI-2018-00759P30CA014089
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Other: Laboratory Biomarker Analysis; Device: Oculus Rift Headset; Other: Questionnaire Administration

Arm II: No Virtual Reality

ACTIVE COMPARATOR

Participants receive standard of care during bone marrow biopsy or lumbar puncture.

Other: Best Practice; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Arm II: No Virtual Reality

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I: Virtual Reality; Arm II: No Virtual Reality

Oculus Rift Headset DEVICE

Subject wears headset for virtual reality intervention during bone marrow biopsy or lumbar puncture procedure

Arm I: Virtual Reality

Questionnaire Administration OTHER

Ancillary studies

Arm I: Virtual Reality; Arm II: No Virtual Reality

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator
• Virtually Strong, LLC: collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Jacek Pinski, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: March 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

US (1)