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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02887989
Recruitment Status : Completed
First Posted : September 2, 2016
Results First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Brennan Spiegel, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE August 30, 2016
First Posted Date  ICMJE September 2, 2016
Results First Submitted Date  ICMJE July 16, 2018
Results First Posted Date  ICMJE November 20, 2018
Last Update Posted Date November 20, 2018
Actual Study Start Date  ICMJE November 16, 2016
Actual Primary Completion Date July 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
  • Pain Intensity Ratings (NRS) [ Time Frame: Approximately every 3-4 hours for the period 48 hours pre and post intervention ]
    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.
  • Morphine Milligram Equivalents (MME) [ Time Frame: assessed at 48 hours before intervention and 48 hours after intervention ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2016)
  • Pain Intensity Ratings (NRS) [ Time Frame: Regularly during hospital stay (up to 20 days) ]
    Patients will provide continuous pain ratings. We will compare the pre-intervention time period to the intervention period.
  • Morphine Milligram Equivalents (MME) [ Time Frame: Regularly during hospital stay (up to 20 days) ]
    We will record the amount of pain medication requested, comparing pre-intervention to intervention period.
  • Time between Medication Requests [ Time Frame: Regularly during hospital stay (up to 20 days) ]
    We will record time between MME doses
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
Length of Stay) LOS [ Time Frame: Count of Days in Hospital Stay up to 20 ]
defined as the number of days from the date of admission to date of hospital discharge. Hour of admission was not available in these data, so patients admitted late on Day 0 (i.e., before midnight), and discharged the following calendar day (i.e., between 00:00 and 23:59), were counted as a 1-day hospital stay. Patients who were admitted and discharged on the same calendar day were considered to have an LOS of 0.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2016)
  • LOS [ Time Frame: Index Hospital Stay ]
    We will count the length of stay for patients in each treatment group.
  • QOL [ Time Frame: 90 days post-discharge ]
    We will assess changes in quality of life, assessed by the PROMIS-10 Global Health Scale
  • Functioning [ Time Frame: 90 days post-discharge ]
    We will assess changes in functioning, assessed by the WHODAS 2.0 scale
  • Patient Satisfaction [ Time Frame: Approximately 6 weeks post-discharge ]
    We will assess satisfaction with hospital stay in both groups using third party surveyor.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immersive Virtual Reality Intervention for Non-Opioid Pain Management: A Randomized Controlled Trial
Official Title  ICMJE Immersive Virtual Reality Intervention for Non-Opioid Pain Management: A Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Pain Management
Intervention  ICMJE
  • Device: 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.
  • Device: Health and Wellness Channel
    Relaxing content broadcast passively on the patient in-room television channel.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Device: Virtual Reality
  • Sham Comparator: '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.
    Intervention: Device: Health and Wellness Channel
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2017)
140
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2016)
120
Actual Study Completion Date  ICMJE August 17, 2017
Actual Primary Completion Date July 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02887989
Other Study ID Numbers  ICMJE Pro00045641
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brennan Spiegel, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brennan Spiegel, MD, MSHS Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP