Clinical trial NCT02887989: Immersive Virtual Reality Intervention for Non-Opioid Pain Management: A Randomized Controlled Trial
Official title: Immersive Virtual Reality Intervention for Non-Opioid Pain Management: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Pain Management
Keywords: Virtual Reality
Non-Opioid Pain Management
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Intensity Ratings (NRS)
timeFrame: Approximately every 3-4 hours for the period 48 hours pre and post intervention
measure: Morphine Milligram Equivalents (MME)
timeFrame: assessed at 48 hours before intervention and 48 hours after intervention
Secondary outcomes:
measure: Length of Stay) LOS
timeFrame: Count of Days in Hospital Stay up to 20
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Brennan Spiegel, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.