An interventional study of Virtual Reality and Health and Wellness Channel in Pain and Pain Management, sponsored by Cedars-Sinai Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2018-11-20.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment
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.
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.
Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Virtual Reality
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.
Device: Health and Wellness Channel
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.
Relaxing content broadcast passively on the patient in-room television channel.
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
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
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
| Milestone | Virtual Reality | In-Room Television |
|---|---|---|
| Started | 70 | 70 |
| Completed | 61 | 59 |
| Not completed | 9 | 11 |
| Withdrew: Withdrawal by subject | 8 | 11 |
| Withdrew: Death | 1 | 0 |
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.
| score on a scale | Virtual Reality | In-Room Television |
|---|---|---|
| Pain Intensity Ratings (NRS) | 4.66 ± 2.91 | 4.94 ± 3.04 |
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.
| Morphine milligram equivalents (MME) | Virtual Reality | In-Room Television |
|---|---|---|
| pre-intervention MME | 75.07 ± 7.25 | 80.83 ± 6.86 |
| post-intervention MME | 77.08 ± 6.34 | 81.04 ± 6.193888 |
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.
| days | Virtual Reality | In-Room Television |
|---|---|---|
| Length of Stay) LOS | 5.11 ± .58 | 5.64 ± .95 |
Collected over 96 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Virtual Reality | 1/70 (1.4%) | 0/70 (0%) | 0/70 (0%) |
| In-Room Television | 0/70 (0%) | 0/70 (0%) | 0/70 (0%) |
| Age, Categorical(Participants) | Virtual Reality | In-Room Television | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 48 | 45 | 93 |
| >=65 years | 13 | 14 | 27 |
| Age, Continuous(years) | Virtual Reality | In-Room Television | Total |
|---|---|---|---|
| Mean | 51.00 ± 15.09 | 50.02 ± 15.92 | 50.8 ± 15.48 |
| Sex: Female, Male(Participants) | Virtual Reality | In-Room Television | Total |
|---|---|---|---|
| Female | 31 | 29 | 60 |
| Male | 30 | 30 | 60 |
| Race/Ethnicity, Customized(Participants) | Virtual Reality | In-Room Television | Total |
|---|---|---|---|
| Race — white | 38 | 39 | 77 |
| Race — African-American | 21 | 10 | 31 |
| Race — Other | 2 | 10 | 12 |
| Region of Enrollment(participants) | Virtual Reality | In-Room Television | Total |
|---|---|---|---|
| United States | 61 | 59 | 120 |
| Pain Type(Participants) | Virtual Reality | In-Room Television | Total |
|---|---|---|---|
| Visceral | 23 | 20 | 43 |
| Somatic | 38 | 39 | 77 |
| Last pain score pre-intervention(units on a scale) | Virtual Reality | In-Room Television | Total |
|---|---|---|---|
| Mean | 3.31 ± 2.83 | 3.97 ± 3.13 | 3.63 ± 2.99 |
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Cedars-Sinai Medical Center