Trial Outcomes & Findings for Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population (NCT NCT06101264)
NCT ID: NCT06101264
Last Updated: 2025-09-22
Results Overview
This tool uses a 10-point scale that ranges from 0 (no pain) to 10 (worst possible pain). Pain will be assessed using this tool before and after every physical therapy session. The change in pain before and after each physical therapy session will be calculated and averaged across each patient.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
2 times daily postoperatively until hospital discharge (up to 60 days postoperatively)
Results posted on
2025-09-22
Participant Flow
Participant milestones
| Measure |
Virtual Reality Intervention
Participants will receive a post-operative virtual reality intervention following corrective surgery for idiopathic scoliosis.
Virtual Reality Intervention: Participants will be given a virtual reality (VR) intervention following corrective scoliosis surgery for adolescent idiopathic scoliosis. The VR intervention will utilize a commercial device manufactured by Oculus. The intervention will utilize a software that simulates a low-physical load environment for the user. Starting on postoperative day 1, the participant will receive a 20-minute VR intervention 30 minutes prior to each physical therapy session. There will be two physical therapy sessions daily. Outcome measures will be assessed before and after every VR intervention and after the physical therapy session. The VR interventions will continue for each postoperative day until the participant is discharged from the hospital.
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Control
Patients that underwent spinal fusion for adolescent idiopathic scoliosis but did not receive virtual reality interventions.
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|---|---|---|
|
Overall Study
STARTED
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10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population
Baseline characteristics by cohort
| Measure |
Virtual Reality Intervention
n=10 Participants
Participants will receive a post-operative virtual reality intervention following corrective surgery for idiopathic scoliosis.
Virtual Reality Intervention: Participants will be given a virtual reality (VR) intervention following corrective scoliosis surgery for adolescent idiopathic scoliosis. The VR intervention will utilize a commercial device manufactured by Oculus. The intervention will utilize a software that simulates a low-physical load environment for the user. Starting on postoperative day 1, the participant will receive a 20-minute VR intervention 30 minutes prior to each physical therapy session. There will be two physical therapy sessions daily. Outcome measures will be assessed before and after every VR intervention and after the physical therapy session. The VR interventions will continue for each postoperative day until the participant is discharged from the hospital.
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Control
n=10 Participants
Control: A retrospective chart review was performed to identify patients that met inclusion criteria. These patients did not undergo virtual reality intervention however the standard of care was identical in both groups. Outcome measures will be assessed before and after the physical therapy session
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Total
n=20 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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15.1 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
15.8 years
STANDARD_DEVIATION 1.3 • n=7 Participants
|
15.5 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 times daily postoperatively until hospital discharge (up to 60 days postoperatively)This tool uses a 10-point scale that ranges from 0 (no pain) to 10 (worst possible pain). Pain will be assessed using this tool before and after every physical therapy session. The change in pain before and after each physical therapy session will be calculated and averaged across each patient.
Outcome measures
| Measure |
Virtual Reality Intervention
n=10 Participants
Participants will receive a post-operative virtual reality intervention following corrective surgery for idiopathic scoliosis.
Virtual Reality Intervention: Participants will be given a virtual reality (VR) intervention following corrective scoliosis surgery for adolescent idiopathic scoliosis. The VR intervention will utilize a commercial device manufactured by Oculus. The intervention will utilize a software that simulates a low-physical load environment for the user. Starting on postoperative day 1, the participant will receive a 20-minute VR intervention 30 minutes prior to each physical therapy session. There will be two physical therapy sessions daily. Outcome measures will be assessed before and after every VR intervention and after the physical therapy session. The VR interventions will continue for each postoperative day until the participant is discharged from the hospital.
|
Control
n=10 Participants
Control: A retrospective chart review was performed to identify patients that met inclusion criteria. These patients did not undergo virtual reality intervention however the standard of care was identical in both groups. Outcome measures will be assessed before and after the physical therapy session,
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|---|---|---|
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Average Change in Subjective Pain Level Using a 10 Point Likert Scale
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-0.72 pain score
Standard Deviation 1.2
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0.61 pain score
Standard Deviation 1.1
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SECONDARY outcome
Timeframe: From post-operative day 1 until hospital discharge (up to 60 days postoperatively)Opioid utilization will be assessed by calculating the total inpatient dose of opioids administered (as documented in the electronic medical record) during the post-operative period, starting from post-operative day 1 until hospital discharge.
Outcome measures
| Measure |
Virtual Reality Intervention
n=10 Participants
Participants will receive a post-operative virtual reality intervention following corrective surgery for idiopathic scoliosis.
Virtual Reality Intervention: Participants will be given a virtual reality (VR) intervention following corrective scoliosis surgery for adolescent idiopathic scoliosis. The VR intervention will utilize a commercial device manufactured by Oculus. The intervention will utilize a software that simulates a low-physical load environment for the user. Starting on postoperative day 1, the participant will receive a 20-minute VR intervention 30 minutes prior to each physical therapy session. There will be two physical therapy sessions daily. Outcome measures will be assessed before and after every VR intervention and after the physical therapy session. The VR interventions will continue for each postoperative day until the participant is discharged from the hospital.
|
Control
n=10 Participants
Control: A retrospective chart review was performed to identify patients that met inclusion criteria. These patients did not undergo virtual reality intervention however the standard of care was identical in both groups. Outcome measures will be assessed before and after the physical therapy session,
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|---|---|---|
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Total Amount of Administered Opioids During the Post-operative Period
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55.7 mg
Standard Deviation 31.7
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49.9 mg
Standard Deviation 19.1
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SECONDARY outcome
Timeframe: Post-operative day 1 until clearance by physical staff (up to 60 days postoperatively)In the postoperative stage, each participant will receive two physical therapy sessions daily. Physical therapy sessions will continue daily until the participant is given clearance by the physical therapy team. To assess the mobilization of participants postoperatively, the total number of physical therapy sessions the participants attend prior to receiving clearance will be noted. The number of total attended physical therapy sessions during the postoperative stage will be averaged across all participants.
Outcome measures
| Measure |
Virtual Reality Intervention
n=10 Participants
Participants will receive a post-operative virtual reality intervention following corrective surgery for idiopathic scoliosis.
Virtual Reality Intervention: Participants will be given a virtual reality (VR) intervention following corrective scoliosis surgery for adolescent idiopathic scoliosis. The VR intervention will utilize a commercial device manufactured by Oculus. The intervention will utilize a software that simulates a low-physical load environment for the user. Starting on postoperative day 1, the participant will receive a 20-minute VR intervention 30 minutes prior to each physical therapy session. There will be two physical therapy sessions daily. Outcome measures will be assessed before and after every VR intervention and after the physical therapy session. The VR interventions will continue for each postoperative day until the participant is discharged from the hospital.
|
Control
n=10 Participants
Control: A retrospective chart review was performed to identify patients that met inclusion criteria. These patients did not undergo virtual reality intervention however the standard of care was identical in both groups. Outcome measures will be assessed before and after the physical therapy session,
|
|---|---|---|
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Average Number of Physical Therapy Sessions Prior to Receiving Clearance by Physical Therapy Staff
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3.2 sessions
Standard Deviation 1.7
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3.2 sessions
Standard Deviation 1.1
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Adverse Events
Virtual Reality Intervention
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Virtual Reality Intervention
n=10 participants at risk
Participants will receive a post-operative virtual reality intervention following corrective surgery for idiopathic scoliosis.
Virtual Reality Intervention: Participants will be given a virtual reality (VR) intervention following corrective scoliosis surgery for adolescent idiopathic scoliosis. The VR intervention will utilize a commercial device manufactured by Oculus. The intervention will utilize a software that simulates a low-physical load environment for the user. Starting on postoperative day 1, the participant will receive a 20-minute VR intervention 30 minutes prior to each physical therapy session. There will be two physical therapy sessions daily. Outcome measures will be assessed before and after every VR intervention and after the physical therapy session. The VR interventions will continue for each postoperative day until the participant is discharged from the hospital.
|
Control
n=10 participants at risk
Patients that underwent corrective surgery for idiopathic scoliosis but did not undergo virtual reality sessions.
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|---|---|---|
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General disorders
Fatigue
|
30.0%
3/10 • Adverse effects were collected during the virtual reality sessions until the patient was discharged from the hospital, up to 60 days postoperatively.
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0.00%
0/10 • Adverse effects were collected during the virtual reality sessions until the patient was discharged from the hospital, up to 60 days postoperatively.
|
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Gastrointestinal disorders
Nausea
|
30.0%
3/10 • Adverse effects were collected during the virtual reality sessions until the patient was discharged from the hospital, up to 60 days postoperatively.
|
0.00%
0/10 • Adverse effects were collected during the virtual reality sessions until the patient was discharged from the hospital, up to 60 days postoperatively.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Adverse effects were collected during the virtual reality sessions until the patient was discharged from the hospital, up to 60 days postoperatively.
|
0.00%
0/10 • Adverse effects were collected during the virtual reality sessions until the patient was discharged from the hospital, up to 60 days postoperatively.
|
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Eye disorders
Eye Strain
|
20.0%
2/10 • Adverse effects were collected during the virtual reality sessions until the patient was discharged from the hospital, up to 60 days postoperatively.
|
0.00%
0/10 • Adverse effects were collected during the virtual reality sessions until the patient was discharged from the hospital, up to 60 days postoperatively.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Adverse effects were collected during the virtual reality sessions until the patient was discharged from the hospital, up to 60 days postoperatively.
|
0.00%
0/10 • Adverse effects were collected during the virtual reality sessions until the patient was discharged from the hospital, up to 60 days postoperatively.
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Additional Information
Prabhath Mannam
University of Connecticut School of Medicine
Phone: 8607092371
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place