Trial Outcomes & Findings for Immersive Virtual Reality Intervention for Non-Opioid Pain Management: A Randomized Controlled Trial (NCT NCT02887989)
NCT ID: NCT02887989
Last Updated: 2018-11-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
Approximately every 3-4 hours for the period 48 hours pre and post intervention
Results posted on
2018-11-20
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
61
|
59
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
11
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Rows differ due to uneven withdrawal and death.
Baseline characteristics by cohort
| Measure |
Virtual Reality
n=61 Participants
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.
|
In-Room Television
n=59 Participants
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.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death.
|
0 Participants
n=7 Participants • Rows differ due to uneven withdrawal and death.
|
0 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death.
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death.
|
45 Participants
n=7 Participants • Rows differ due to uneven withdrawal and death.
|
93 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death.
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death.
|
14 Participants
n=7 Participants • Rows differ due to uneven withdrawal and death.
|
27 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death.
|
|
Age, Continuous
|
51.00 years
STANDARD_DEVIATION 15.09 • n=5 Participants • Rows differ due to uneven withdrawal and death
|
50.02 years
STANDARD_DEVIATION 15.92 • n=7 Participants • Rows differ due to uneven withdrawal and death
|
50.8 years
STANDARD_DEVIATION 15.48 • n=5 Participants • Rows differ due to uneven withdrawal and death
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death.
|
29 Participants
n=7 Participants • Rows differ due to uneven withdrawal and death.
|
60 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death.
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death.
|
30 Participants
n=7 Participants • Rows differ due to uneven withdrawal and death.
|
60 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death.
|
|
Race/Ethnicity, Customized
Race · white
|
38 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death
|
39 Participants
n=7 Participants • Rows differ due to uneven withdrawal and death
|
77 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death
|
|
Race/Ethnicity, Customized
Race · African-American
|
21 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death
|
10 Participants
n=7 Participants • Rows differ due to uneven withdrawal and death
|
31 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death
|
|
Race/Ethnicity, Customized
Race · Other
|
2 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death
|
10 Participants
n=7 Participants • Rows differ due to uneven withdrawal and death
|
12 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
59 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Pain Type
Visceral
|
23 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death
|
20 Participants
n=7 Participants • Rows differ due to uneven withdrawal and death
|
43 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death
|
|
Pain Type
Somatic
|
38 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death
|
39 Participants
n=7 Participants • Rows differ due to uneven withdrawal and death
|
77 Participants
n=5 Participants • Rows differ due to uneven withdrawal and death
|
|
Last pain score pre-intervention
|
3.31 units on a scale
STANDARD_DEVIATION 2.83 • n=5 Participants • Rows differ due to uneven withdrawal and death
|
3.97 units on a scale
STANDARD_DEVIATION 3.13 • n=7 Participants • Rows differ due to uneven withdrawal and death
|
3.63 units on a scale
STANDARD_DEVIATION 2.99 • n=5 Participants • Rows differ due to uneven withdrawal and death
|
PRIMARY outcome
Timeframe: Approximately every 3-4 hours for the period 48 hours pre and post interventionThe 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.
Outcome measures
| Measure |
Virtual Reality
n=61 Participants
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.
|
In-Room Television
n=59 Participants
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.
|
|---|---|---|
|
Pain Intensity Ratings (NRS)
|
4.66 score on a scale
Standard Deviation 2.91
|
4.94 score on a scale
Standard Deviation 3.04
|
PRIMARY outcome
Timeframe: assessed at 48 hours before intervention and 48 hours after interventionPopulation: Not all patients received opioids
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.
Outcome measures
| Measure |
Virtual Reality
n=48 Participants
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.
|
In-Room Television
n=53 Participants
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.
|
|---|---|---|
|
Morphine Milligram Equivalents (MME)
post-intervention MME
|
77.08 Morphine milligram equivalents (MME)
Standard Deviation 6.34
|
81.04 Morphine milligram equivalents (MME)
Standard Deviation 6.193888
|
|
Morphine Milligram Equivalents (MME)
pre-intervention MME
|
75.07 Morphine milligram equivalents (MME)
Standard Deviation 7.25
|
80.83 Morphine milligram equivalents (MME)
Standard Deviation 6.86
|
SECONDARY outcome
Timeframe: Count of Days in Hospital Stay up to 20defined 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.
Outcome measures
| Measure |
Virtual Reality
n=61 Participants
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.
|
In-Room Television
n=59 Participants
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.
|
|---|---|---|
|
Length of Stay) LOS
|
5.11 days
Standard Deviation .58
|
5.64 days
Standard Deviation .95
|
Adverse Events
Virtual Reality
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
In-Room Television
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place