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

NCT ID: NCT03568292

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2027-03-01

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.

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).

Conditions

Malignant Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Oculus Rift Headset

Intervention Type: DEVICE

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

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Arm II: No Virtual Reality

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

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Receive standard of care

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Best Practice

Receive standard of care

Intervention Type: OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Oculus Rift Headset

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

Intervention Type: DEVICE

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

standard of care; standard therapy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Virtually Strong, LLC

UNKNOWN

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacek Pinski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

0S-17-10

Identifier Type: -

Identifier Source: org_study_id

NCI-2018-00759

Identifier Type: REGISTRY

Identifier Source: secondary_id

0S-17-10

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

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