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

Malignant Neoplasm Clinical Trial

Official title:

Effects of Virtual Reality on Pain and Anxiety in Cancer Patients Undergoing Painful Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03568292
• Other study ID #: 0S-17-10
• Secondary ID: NCI-2018-007590S
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: August 2023
• Source: University of Southern California
• Contact: Cheryl Kefauver, RN
• Phone: 323-865-0459
• Email: Cheryl.Kefauver[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Best Practice
Receive standard of care
• 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

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI), Virtually Strong, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Anxiety	Will be assessed by the State-Trait Anxiety Inventory.	Up to 1 year