Immersive Virtual Reality Intervention for Non-Opioid Pain Management: A Randomized Controlled Trial

NCT02887989 | Completed Results DMC

• 1 other identifier: Pro00045641
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a randomized controlled trial (RCT) of VR non-opioid management vs. a control "sham" intervention for a broad and representative group of medical and surgical patients with pain. Hospitalized patients will receive specialized VR interventions, administered via portable VR headsets, to manage breakthrough pain. Control patients will view content on the in-room Health and Wellness television channel. Investigators will follow patients throughout the course of their hospitalization and monitor outcomes during and after their stays, including pain levels, medication requests, and quality of life.

Conditions

Pain; Pain Management

Keywords

Virtual Reality; Non-Opioid Pain Management

Outcome Measures

Primary Outcomes (2)

• Pain Intensity Ratings (NRS)

  The primary outcome was pain intensity collected via ecological momentary assessment in the course of usual care by hospital staff. At three-to-four hour intervals during waking hours, subjects were asked by their assigned nurse to rate their pain using a standard 11-point numeric rating scale (NRS), where 0 is "no pain" and 10 is "worst imaginable pain." Data are summarized as pre/post mean and in time-series.

  Approximately every 3-4 hours for the period 48 hours pre and post intervention

• Morphine Milligram Equivalents (MME)

  Opioid usage was defined as mean total milligrams of morphine equivalent (MME), calculated by first multiplying the quantity of each prescribed medication by the strength of that medication (milligrams of given opioid per unit dispensed), and then multiplying this quantity-strength product by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The mean pre-intervention MME for subjects in each arm was calculated by adding the morphine equivalents for each prescription dispensed during the 48 hours before intervention, while the post-intervention MME for subjects in each arm was calculated by adding the morphine equivalents for each prescription dispensed during the 48 hours after intervention.

  assessed at 48 hours before intervention and 48 hours after intervention

Secondary Outcomes (1)

• Length of Stay) LOS

  Count of Days in Hospital Stay up to 20

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Patients will be allowed to use commercially-available VR equipment in their hospital rooms for up to 20 days, as needed to manage pain as an adjunct to opioid and non-opioid pain medication.

Device: Virtual Reality

'Health and Wellness Channel'

SHAM COMPARATOR

Patients will be allowed to watch relaxing television content in their hospital rooms for up to 20 days, as needed to manage pain as an adjunct to opioid and non-opioid pain medication.

Device: Health and Wellness Channel

Interventions

Virtual Reality DEVICE

A menu of VR experiences, lasting from 3-30 minutes each. For example, patients may watch a soothing virtual campfire, or fly over a scenic landscape, or play an interactive game.

Virtual Reality

Health and Wellness Channel DEVICE

Relaxing content broadcast passively on the patient in-room television channel.

'Health and Wellness Channel'

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand the goals of the study and provide informed consent
• Any hospitalized patient under care of CSMC inpatient service (ISP), gastroenterology, or psychiatry, admitted between November 2016 and 30 September 2017, who is not excluded due to criteria listed below.
• At least one pain score ≥ 3 documented in the EHR.
• Received at least three doses of opioid medication for breakthrough pain, documented in the EHR.
• At least 18 years of age
• English speaking

You may not qualify if:

• Unable to consent to study due to cognitive difficulty
• Contact Isolation
• Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware and software
• Sensitivity to flashing light or motion
• Pregnancy, or a medical condition where the patient is prone to frequent nausea or dizziness
• Recent stroke
• Post-transplant patient, or pre-transplant patient with severe illness
• Patient on ventilator, BiPAP, or other breathing assistance equipment
• Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of the hardware (e.g., open sores, wounds, or skin rash on face)
• Non-English speaking

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

• Mosadeghi S, Reid MW, Martinez B, Rosen BT, Spiegel BM. Feasibility of an Immersive Virtual Reality Intervention for Hospitalized Patients: An Observational Cohort Study. JMIR Ment Health. 2016 Jun 27;3(2):e28. doi: 10.2196/mental.5801.

  PMID: 27349654 BACKGROUND

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Limitations and Caveats

Usage data was not collected, so no conclusions regarding actual dose/response can be made.

Results Point of Contact

• Title: Garth Fuller
• Organization: Cedars-Sinai Health System

garth.fuller@cshs.org

3236003890

Study Officials

• Brennan Spiegel, MD, MSHS

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Health Services Research

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 2, 2016
• Study Start: November 16, 2016
• Primary Completion: July 17, 2017
• Study Completion: August 17, 2017
• Last Updated: November 20, 2018
• Results First Posted: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)