Immersive Virtual Reality Intervention for Non-Opioid Pain Management: A Randomized Controlled Trial
Status: | Completed |
---|---|
Conditions: | Chronic Pain, Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - 110 |
Updated: | 11/22/2018 |
Start Date: | November 16, 2016 |
End Date: | August 17, 2017 |
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.
"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.
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.
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.
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
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