Clinical trial NCT03568292: Virtual Reality in Reducing Pain and Anxiety in Cancer Participants Undergoing Painful Procedures
Official title: Effects of Virtual Reality on Pain and Anxiety in Cancer Patients Undergoing Painful Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Neoplasm
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Virtually Strong, LLC
First posted: 2018-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Pain as assessed according to a visual analog scale (VAS)
timeFrame: Up to 1 year
measure: Anxiety
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Jacek Pinski, MD
role: PRINCIPAL_INVESTIGATOR
References: