Influence of Virtual Reality Distraction on Pain and Satisfaction During Outpatient Pediatric Orthopedic Procedures: A Randomized Controlled Study
Phase: NA
Conditions: Fractures, Bone, Deformity; Bone
Sponsor: Hospital for Special Surgery, New York

Official Title: Influence of Virtual Reality Distraction on Pain and Satisfaction During 
Outpatient Pediatric Orthopedic Procedures: A Randomized Controlled Study   
 
NCT Number: NCT05510232 
 
Document Date: July 25, 2018 
 
 

OBJECTIVES: 
To compare the effectiveness of VR gaming simulation to two forms of non-interactive visual 
distraction on reducing objective and subjective measures of pain and anxiety in pediatric 
patients undergoing in office cast removal or surgical suture and pin removal.   
 
 
DESIGN: 
The study will be comprised of two treatment arms: 
i) 
A casting treatment arm  
ii) 
A pin/suture removal treatment arm  
Each treatment arm will have three groups:  
i) 
A treatment group that will be immersed in the VR game (Bear Blast) via the 
headset. 
ii) 
A treatment group that will have headset on and will watch a VR video  
iii) 
A treatment group that will watch a non-VR video via an iPad 
 
Cast/Suture and Pins will be removed from both the upper and the lower extremities. 
 
Headset setup will be done completely by research team and does not involve the extremities for 
engagement with the interface. Children in the ipad group will have iPad set up by the research 
team. 
 
 
METHODS: 
 
VR Headset Group:  
1. Demographic appropriate screening for inclusion ( including age and available past 
medical history) 
2. Patient consent (before randomization) 
3. VR assembly and administration (description below) 
4. Cast sawing 
5. physical examination (before and after procedure) 
6. pulse oximetry application (HR measured 3 minutes pre-procedure and throughout entire 
procedure) 
7. NRS VAS pain administration (3 minutes pre-procedure and immediately post-
procedure) in patients over 8 (Will mark on scale) 
8. VAS Faces pain administration (3 minutes pre-procedure and immediately post-
procedure) in patients under 8 years (Will point to face) 
9. NRS VAS anxiety administration (3 minutes pre-procedure and immediately post-
procedure) (Will mark on scale) 
10. VAS Faces anxiety scale administration (3 minutes pre-procedure and immediately post-
procedure) in patients under 8 years (Will point to face) 
11. Patient/parent satisfaction administration (post-procedure)  
  
Headset Video Group: 

1. Demographic appropriate screening for inclusion ( including age and available past 
medical history) 
2. Patient consent (before randomization) 
3. Video administration via headset (description below) 
4. Cast sawing 
5. Physical examination (before and after procedure) 
6. Pulse oximetry application (HR measured 3 minutes pre-procedure and throughout entire 
procedure) 
7. NRS VAS pain administration (3 minutes pre-procedure and immediately post-
procedure) in patients over 8 years (Will mark on scale) 
8. VAS Faces pain administration (3 minutes pre-procedure and immediately post-
procedure) in patients under 8 years (Will point to face) 
9. NRS VAS anxiety administration (3 minutes pre-procedure and immediately post-
procedure) (Will mark on scale) 
10. VAS Faces anxiety administration (3 minutes pre-procedure and immediately post-
procedure) in patients under 8 years (Will point to face) 
11. Patient/parent satisfaction administration (post-procedure) 
  
iPad Group: 
1. Demographic appropriate screening for inclusion ( including age and available past 
medical history) 
2. Patient consent (before randomization) 
3. iPad administration (description below) 
4. cast sawing 
5. physical examination (before and after procedure) 
6. pulse oximetry application (HR measured 3 minutes pre-procedure and throughout entire 
procedure) 
7. NRS VAS pain administration (3 minutes pre-procedure and immediately post-
procedure) in patients over 8 years (Will mark on scale) 
8. VAS Faces pain administration (3 minutes pre-procedure and immediately post-
procedure) in patients under 8 years (Will point to face) 
9. NRS VAS anxiety administration (3 minutes pre-procedure and immediately post-
procedure) (Will mark on scale) 
10. VAS Faces anxiety scale administration in patients under 8 years (Will point to face) 
11. Patient/parent satisfaction administration (post-procedure) 
  
Virtual Reality Platform with Headset (administration): 
VR 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 reality Samsung 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.  

  
 Video with Headset (administration): 
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.  
  
Video with iPad (administration): 
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. 
 
 
STATISTICAL ANALYSIS PLAN: 
 
• Statistical test (T-test, ANOVA, chi-square, regression, etc): One-way analysis of 
variance (ANOVA) 
• Alpha level: 0.017 
• Beta or power level: 0.899 
• Primary outcome to be measured (and how it will be operationalized): Heart rate in 
each study group. A mean of +6.7 beats per minute and standard deviation 1.4 has been 
previously reported in an outpatient pediatric orthopedic population. 
• Number of groups being compared (use 1 for paired analysis): 3 
• Effect size or change expected between groups: 15% difference in the increase in HR 
from baseline to the maximum rate during the procedure, and therefore assuming a true 
difference in the experimental and control means is greater than 1 beat per minute. 
• Resulting number per group and total sample size: 35 per groups, 105 total