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

University of Southern California

Status: Suspended

Conditions: Malignant Neoplasm

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03568292

0S-17-10 (Other Identifier)

NCI-2018-00759 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Arm I: Virtual Reality

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Device: Oculus Rift Headset

Other: Laboratory Biomarker Analysis

Arm II: No Virtual Reality

Active Comparator group

Description:

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

Treatment:

Other: Questionnaire Administration

Other: Laboratory Biomarker Analysis

Other: Best Practice