Pain, Pain Management
Conditions
Keywords
Virtual Reality, Non-Opioid Pain Management
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.
Interventions
DEVICEVirtual 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.
DEVICEHealth and Wellness Channel
Relaxing content broadcast passively on the patient in-room television channel.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Ratings (NRS) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay) LOS | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 61 |
| In-Room Television 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.
Health and Wellness Channel: Relaxing content broadcast passively on the patient in-room television channel. | 59 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Withdrawal by Subject | 8 | 11 |
Baseline characteristics
| Characteristic | Virtual Reality | In-Room Television | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 14 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 45 Participants | 93 Participants |
| Age, Continuous | 51.00 years STANDARD_DEVIATION 15.09 | 50.02 years STANDARD_DEVIATION 15.92 | 50.8 years STANDARD_DEVIATION 15.48 |
| Last pain score pre-intervention | 3.31 units on a scale STANDARD_DEVIATION 2.83 | 3.97 units on a scale STANDARD_DEVIATION 3.13 | 3.63 units on a scale STANDARD_DEVIATION 2.99 |
| Pain Type Somatic | 38 Participants | 39 Participants | 77 Participants |
| Pain Type Visceral | 23 Participants | 20 Participants | 43 Participants |
| Race/Ethnicity, Customized Race African-American | 21 Participants | 10 Participants | 31 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 10 Participants | 12 Participants |
| Race/Ethnicity, Customized Race white | 38 Participants | 39 Participants | 77 Participants |
| Region of Enrollment United States | 61 participants | 59 participants | 120 participants |
| Sex: Female, Male Female | 31 Participants | 29 Participants | 60 Participants |
| Sex: Female, Male Male | 30 Participants | 30 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 70 | 0 / 70 |
| other Total, other adverse events | 0 / 70 | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
Primary
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.
Time frame: assessed at 48 hours before intervention and 48 hours after intervention
Population: Not all patients received opioids
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Virtual Reality | Morphine Milligram Equivalents (MME) | pre-intervention MME | 75.07 Morphine milligram equivalents (MME) | Standard Deviation 7.25 |
| Virtual Reality | Morphine Milligram Equivalents (MME) | post-intervention MME | 77.08 Morphine milligram equivalents (MME) | Standard Deviation 6.34 |
| In-Room Television | Morphine Milligram Equivalents (MME) | pre-intervention MME | 80.83 Morphine milligram equivalents (MME) | Standard Deviation 6.86 |
| In-Room Television | Morphine Milligram Equivalents (MME) | post-intervention MME | 81.04 Morphine milligram equivalents (MME) | Standard Deviation 6.193888 |
p-value: 0.657t-test, 2 sided
Primary
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.
Time frame: Approximately every 3-4 hours for the period 48 hours pre and post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality | Pain Intensity Ratings (NRS) | 4.66 score on a scale | Standard Deviation 2.91 |
| In-Room Television | Pain Intensity Ratings (NRS) | 4.94 score on a scale | Standard Deviation 3.04 |
Secondary
Length of Stay) LOS
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.
Time frame: Count of Days in Hospital Stay up to 20
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality | Length of Stay) LOS | 5.11 days | Standard Deviation 0.58 |
| In-Room Television | Length of Stay) LOS | 5.64 days | Standard Deviation 0.95 |
p-value: 0.6339t-test, 2 sided