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

NCT ID: NCT02887989

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-16
• Study Completion Date: 2017-08-17

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.

Detailed Description

The study population will consist of 120 patients - 60 patients who are exposed to VR, and 60 control patients exposed to an audiovisual "sham" intervention. Investigators will select up to 120 hospitalized patients at CSMC admitted during the study period of November 2016 to September 2017. The inpatient wards serve patients ranging in age from 18 to over 100, allowing us to assess the feasibility of using VR across diverse age groups. Appropriate inpatients will be selected at random by Dr. Rosen or other authorized co-investigators or study staff, who will obtain relevant clinical variables from the EHR. All patients admitted to the hospital will be considered for the study. The location and identity of the inpatient will be relayed by their attending physician to a member of the study team, who will deliver a randomly selected intervention (either VR or Health and Wellness Channel) to the patient the same day (at the patient's discretion). The patient will continue usage as needed for up to 20 days of the hospital stay. VR Interventions include both relaxing environment and engaging games. The Health and Wellness Channel includes some of the same types of content, but it is delivered passively through the in-room television system. Investigators will examine changes in pain level, length of stay, medication requests (amount and timing), Quality of Life, Functioning, and Patient Satisfaction.

Conditions

Pain; Pain Management

Study Design

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

Study Groups

Virtual Reality

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: 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.

'Health and Wellness Channel'

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.

Group Type: SHAM_COMPARATOR

Health and Wellness Channel

Intervention Type: DEVICE

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

Interventions

Virtual Reality

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.

Intervention Type: DEVICE

Health and Wellness Channel

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Brennan Spiegel

Director, Health Services Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brennan Spiegel, MD, MSHS

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27349654 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00045641

Identifier Type: -

Identifier Source: org_study_id