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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pain
Pain Management
Interventions Device: Virtual Reality
Device: Health and Wellness Channel
Enrollment 140
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Virtual Reality In-Room Television
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 70 70
Completed 61 59
Not Completed 9 11
Reason Not Completed
Withdrawal by Subject             8             11
Death             1             0
Arm/Group Title Virtual Reality In-Room Television Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 61 59 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 59 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
48
  78.7%
45
  76.3%
93
  77.5%
>=65 years
13
  21.3%
14
  23.7%
27
  22.5%
[1]
Measure Analysis Population Description: Rows differ due to uneven withdrawal and death.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 59 participants 120 participants
51.00  (15.09) 50.02  (15.92) 50.8  (15.48)
[1]
Measure Analysis Population Description: Rows differ due to uneven withdrawal and death
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 59 participants 120 participants
Female
31
  50.8%
29
  49.2%
60
  50.0%
Male
30
  49.2%
30
  50.8%
60
  50.0%
[1]
Measure Analysis Population Description: Rows differ due to uneven withdrawal and death.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 61 participants 59 participants 120 participants
white
38
  62.3%
39
  66.1%
77
  64.2%
African-American
21
  34.4%
10
  16.9%
31
  25.8%
Other
2
   3.3%
10
  16.9%
12
  10.0%
[1]
Measure Analysis Population Description: Rows differ due to uneven withdrawal and death
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 61 participants 59 participants 120 participants
61 59 120
[1]
Measure Description: Rows differ due to uneven withdrawal and death
Pain Type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 59 participants 120 participants
Visceral
23
  37.7%
20
  33.9%
43
  35.8%
Somatic
38
  62.3%
39
  66.1%
77
  64.2%
[1]
Measure Analysis Population Description: Rows differ due to uneven withdrawal and death
Last pain score pre-intervention   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 61 participants 59 participants 120 participants
3.31  (2.83) 3.97  (3.13) 3.63  (2.99)
[1]
Measure Description: 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.”
[2]
Measure Analysis Population Description: Rows differ due to uneven withdrawal and death
1.Primary Outcome
Title Pain Intensity Ratings (NRS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Virtual Reality In-Room Television
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 61 59
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.66  (2.91) 4.94  (3.04)
2.Primary Outcome
Title Morphine Milligram Equivalents (MME)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Not all patients received opioids
Arm/Group Title Virtual Reality In-Room Television
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 48 53
Mean (Standard Deviation)
Unit of Measure: Morphine milligram equivalents (MME)
pre-intervention MME 75.07  (7.25) 80.83  (6.86)
post-intervention MME 77.08  (6.34) 81.04  (6.193888)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Virtual Reality, In-Room Television
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .6570
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Length of Stay) LOS
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Virtual Reality In-Room Television
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 61 59
Mean (Standard Deviation)
Unit of Measure: days
5.11  (.58) 5.64  (.95)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Virtual Reality, In-Room Television
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .6339
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 96 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Virtual Reality In-Room Television
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Virtual Reality In-Room Television
Affected / at Risk (%) Affected / at Risk (%)
Total   1/70 (1.43%)   0/70 (0.00%) 
Hide Serious Adverse Events
Virtual Reality In-Room Television
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   0/70 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Virtual Reality In-Room Television
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)   0/70 (0.00%) 
Usage data was not collected, so no conclusions regarding actual dose/response can be made.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Garth Fuller
Organization: Cedars-Sinai Health System
Phone: 3236003890
EMail: garth.fuller@cshs.org
Layout table for additonal information
Responsible Party: Brennan Spiegel, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02887989    
Other Study ID Numbers: Pro00045641
First Submitted: August 30, 2016
First Posted: September 2, 2016
Results First Submitted: July 16, 2018
Results First Posted: November 20, 2018
Last Update Posted: November 20, 2018