Trial Outcomes & Findings for Virtual Reality Distraction During Outpatient Pediatric Orthopedic Procedures (NCT NCT05510232)
NCT ID: NCT05510232
Last Updated: 2025-01-31
Results Overview
Pulse oximetry application
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
226 participants
Primary outcome timeframe
3 minutes pre-procedure until 1 minute post-procedure, up to 20 minutes
Results posted on
2025-01-31
Participant Flow
Some participants did not tolerate the distraction method (e.g. removed virtual reality headset) or removed the heart rate monitor.
Participant milestones
| Measure |
A Treatment Group That Will Watch a Non-VR Video Via an iPad
A treatment group that will watch a non-VR video via an iPad: The iPad is a tablet computer first offered by Apple in 2010.The device resembles a much larger version of Apple's iPhone or its iPod Touch, and is about the same size as a magazine. The iPad uses the same operating system as the Apple iPhone, and uses very similar hardware. iPad will be used to deliver non VR video to patients.
A standardized age appropriate video will be used for patients between ages 414. The selected videos will be the same for both the cast and suture/pin removal groups.
|
A Treatment Group That Will Have Headset on and Will Watch a VR Video
A treatment group that will have headset on and will watch a VR video: Oculus headset will deliver non VR video to patients. Headset will be administered before intervention and removed at the completion of the intervention unless patient requests otherwise. Patients visual field will not change with head motion and will remain static throughout cast removal or pin/suture removal.
A standardized age appropriate video will be used for patients between ages 414. The selected videos will be the same for both the cast and suture/pin removal groups.
|
A Treatment Group That Will be Immersed in the VR Game (Bear Blast) Via the Headset.
A treatment group that will be immersed in the VR game (Bear Blast) via the headset.: VR using the Oculus headset will deliver VR images and sound. Patients will watch a 15-minute VR experience called Bear Blast. Bear Blast is an immersive, 360-degree, game experience that takes place in a fantasy world where the user attempts to shoot balls at a wide range of moving objects by gently maneuvering his or her head toward the targets. Bear Blast is a nonviolent and noncompetitive game that incorporates motivational music and features positively reinforcing sounds, animation, and direct messages to patients. Bear Blast will be used as the standardized game for all patients in the VR group of both study arms. The VR Oculus headset can be controlled entirely via head motion and does not involve the use of patients extremities.
|
|---|---|---|---|
|
Overall Study
STARTED
|
76
|
80
|
70
|
|
Overall Study
COMPLETED
|
74
|
73
|
64
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
6
|
Reasons for withdrawal
| Measure |
A Treatment Group That Will Watch a Non-VR Video Via an iPad
A treatment group that will watch a non-VR video via an iPad: The iPad is a tablet computer first offered by Apple in 2010.The device resembles a much larger version of Apple's iPhone or its iPod Touch, and is about the same size as a magazine. The iPad uses the same operating system as the Apple iPhone, and uses very similar hardware. iPad will be used to deliver non VR video to patients.
A standardized age appropriate video will be used for patients between ages 414. The selected videos will be the same for both the cast and suture/pin removal groups.
|
A Treatment Group That Will Have Headset on and Will Watch a VR Video
A treatment group that will have headset on and will watch a VR video: Oculus headset will deliver non VR video to patients. Headset will be administered before intervention and removed at the completion of the intervention unless patient requests otherwise. Patients visual field will not change with head motion and will remain static throughout cast removal or pin/suture removal.
A standardized age appropriate video will be used for patients between ages 414. The selected videos will be the same for both the cast and suture/pin removal groups.
|
A Treatment Group That Will be Immersed in the VR Game (Bear Blast) Via the Headset.
A treatment group that will be immersed in the VR game (Bear Blast) via the headset.: VR using the Oculus headset will deliver VR images and sound. Patients will watch a 15-minute VR experience called Bear Blast. Bear Blast is an immersive, 360-degree, game experience that takes place in a fantasy world where the user attempts to shoot balls at a wide range of moving objects by gently maneuvering his or her head toward the targets. Bear Blast is a nonviolent and noncompetitive game that incorporates motivational music and features positively reinforcing sounds, animation, and direct messages to patients. Bear Blast will be used as the standardized game for all patients in the VR group of both study arms. The VR Oculus headset can be controlled entirely via head motion and does not involve the use of patients extremities.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
7
|
6
|
Baseline Characteristics
Virtual Reality Distraction During Outpatient Pediatric Orthopedic Procedures
Baseline characteristics by cohort
| Measure |
A Treatment Group That Will Watch a Non-VR Video Via an iPad
n=76 Participants
A treatment group that will watch a non-VR video via an iPad: The iPad is a tablet computer first offered by Apple in 2010.The device resembles a much larger version of Apple's iPhone or its iPod Touch, and is about the same size as a magazine. The iPad uses the same operating system as the Apple iPhone, and uses very similar hardware. iPad will be used to deliver non VR video to patients.
A standardized age appropriate video will be used for patients between ages 4-14. The selected videos will be the same for both the cast and suture/pin removal groups.
|
A Treatment Group That Will Have Headset on and Will Watch a VR Video
n=80 Participants
A treatment group that will have headset on and will watch a VR video: Oculus headset will deliver VR video to patients. Headset will be administered before intervention and removed at the completion of the intervention unless patient requests otherwise. Patients visual field will not change with head motion and will remain static throughout cast removal or pin/suture removal.
A standardized age appropriate video will be used for patients between ages 4-14. The selected videos will be the same for both the cast and suture/pin removal groups.
|
A Treatment Group That Will be Immersed in the VR Game (Bear Blast) Via the Headset.
n=70 Participants
A treatment group that will be immersed in the VR game (Bear Blast) via the headset.: VR using the Oculus headset will deliver VR images and sound. Patients will watch a 15-minute VR experience called Bear Blast. Bear Blast is an immersive, 360-degree, game experience that takes place in a fantasy world where the user attempts to shoot balls at a wide range of moving objects by gently maneuvering his or her head toward the targets. Bear Blast is a nonviolent and noncompetitive game that incorporates motivational music and features positively reinforcing sounds, animation, and direct messages to patients. Bear Blast will be used as the standardized game for all patients in the VR group of both study arms. The VR Oculus headset can be controlled entirely via head motion and does not involve the use of patients extremities. iPad will be set up and held for patients in the iPad group.
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
76 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
226 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
9 years
STANDARD_DEVIATION 3 • n=5 Participants
|
9 years
STANDARD_DEVIATION 3 • n=7 Participants
|
9 years
STANDARD_DEVIATION 3 • n=5 Participants
|
9 years
STANDARD_DEVIATION 3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
80 participants
n=7 Participants
|
70 participants
n=5 Participants
|
226 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 minutes pre-procedure until 1 minute post-procedure, up to 20 minutesPulse oximetry application
Outcome measures
| Measure |
A Treatment Group That Will Watch a Non-VR Video Via an iPad
n=74 Participants
A treatment group that will watch a non-VR video via an iPad: The iPad is a tablet computer first offered by Apple in 2010.The device resembles a much larger version of Apple's iPhone or its iPod Touch, and is about the same size as a magazine. The iPad uses the same operating system as the Apple iPhone, and uses very similar hardware. iPad will be used to deliver non VR video to patients.
A standardized age appropriate video will be used for patients between ages 4-14. The selected videos will be the same for both the cast and suture/pin removal groups.
|
A Treatment Group That Will Have Headset on and Will Watch a Non-VR Video
n=73 Participants
A treatment group that will have headset on and will watch a VR video: Oculus headset will deliver VR video to patients. Headset will be administered before intervention and removed at the completion of the intervention unless patient requests otherwise. Patients visual field will not change with head motion and will remain static throughout cast removal or pin/suture removal.
A standardized age appropriate video will be used for patients between ages 4-14. The selected videos will be the same for both the cast and suture/pin removal groups.
|
A Treatment Group That Will be Immersed in the VR Game (Bear Blast) Via the Headset.
n=64 Participants
A treatment group that will be immersed in the VR game (Bear Blast) via the headset.: VR using the Oculus headset fitted with a Samsung Galaxy S7 phone will deliver VR images and sound. Patients will watch a 15-minute VR experience called Bear Blast. Bear Blast is an immersive, 360-degree, game experience that takes place in a fantasy world where the user attempts to shoot balls at a wide range of moving objects by gently maneuvering his or her head toward the targets. Bear Blast is a nonviolent and noncompetitive game that incorporates motivational music and features positively reinforcing sounds, animation, and direct messages to patients. Bear Blast will be used as the standardized game for all patients in the VR group of both study arms. The VR Oculus headset can be controlled entirely via head motion and does not involve the use of patients extremities. iPad will be set up and held for patients in the iPad group.
|
|---|---|---|---|
|
Absolute Difference in HR as Measured 3 Minutes Prior to Procedure and Maximum as Measured During Through 1 Minute After Procedure.
|
20 beats per minute
Standard Deviation 16
|
20 beats per minute
Standard Deviation 16
|
21 beats per minute
Standard Deviation 16
|
SECONDARY outcome
Timeframe: 3 minutes before and immediately after interventionDifference in VAS pain score as measured 3 minutes before and immediately after intervention. This score is measured on a scale from 0-10, with 10 meaning the worst pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 minutes before and immediately after interventionDifference in VAS anxiety score as measured 3 minutes before and immediately after intervention. This score is measured on a scale from 0-10, with 10 meaning the worst anxiety.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Immediately after interventionParent/guardian satisfaction is measured by a question asking the parent/guardian's satisfaction with the entire procedure on a scale from 1-10, where 10 is the most satisfied.
Outcome measures
Outcome data not reported
Adverse Events
A Treatment Group That Will Watch a Non-VR Video Via an iPad
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
A Treatment Group That Will Have Headset on and Will Watch a VR Video
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
A Treatment Group That Will be Immersed in the VR Game (Bear Blast) Via the Headset.
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