Adolescent Idiopathic Scoliosis
Conditions
Brief summary
The purpose of this study is to assess the effect of virtual reality on subjective post-operative pain, total inpatient narcotic administration, and mobilization with physical therapy in pediatric patients who have undergone surgical correction for idiopathic scoliosis.
Detailed description
All pediatric patients (ages 13-18) at Connecticut Children's Medical Center undergoing corrective scoliosis surgery for idiopathic scoliosis are eligible and will be approached for consent and inclusion into the study. This is a prospective pilot study, and all enrolled patients will receive a virtual reality (VR) intervention using a commercially available device manufactured by Oculus. The VR software will simulate a low physical load environment, such as an underwater space exploration game. Starting on postoperative day 1, the prospective cohort will undergo a 20-minute VR session 30 minutes prior to each physical therapy session. There will be two physical therapy sessions scheduled daily for the participant. Outcome measures will be assessed before and after the VR session and after the physical therapy session. The following procedures will continue daily until the participant is cleared for hospital discharge. Patients that met study eligibility but elected not to participate in the VR intervention were analyzed as the control group.
Interventions
DEVICEControl
Control patients following spinal fusion for adolescent idiopathic scoliosis that receive no virtual reality sessions.
DEVICEVirtual Reality
Patients will undergo a 20 minute virtual reality session prior to each physical therapy session following spinal fusion for adolescent idiopathic scoliosis. Virtual reality sessions will continue until functionally cleared by physical therapy.
Sponsors
University of Connecticut
Connecticut Children's Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* All pediatric patients (ages 13-18) at Connecticut Children's undergoing surgical correction for idiopathic scoliosis over a span of 12 months
Exclusion criteria
* History of seizures * Cognitive developmental delay precluding participation in VR * Head or neck surgery that does not allow a head-mounted display to be worn safely * Chronic pain requiring the daily use of opioids for more than 2 weeks prior to the procedure * Non-English speakers * Side effects during screening * Patients with vagal nerve stimulators, cardiac pacemakers, and/or cochlear implants that may receive interference from the VR device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Change in Subjective Pain Level Using a 10 Point Likert Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Administered Opioids During the Post-operative Period | 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. |
| Average Number of Physical Therapy Sessions Prior to Receiving Clearance by Physical Therapy Staff | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Control 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 | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Control | Total | Virtual Reality Intervention |
|---|---|---|---|
| Age, Continuous | 15.8 years STANDARD_DEVIATION 1.3 | 15.5 years STANDARD_DEVIATION 1.5 | 15.1 years STANDARD_DEVIATION 1.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 11 Participants | 8 Participants |
| Sex: Female, Male Female | 3 Participants | 12 Participants | 9 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 6 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Average Change in Subjective Pain Level Using a 10 Point Likert Scale
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.
Time frame: 2 times daily postoperatively until hospital discharge (up to 60 days postoperatively)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Intervention | Average Change in Subjective Pain Level Using a 10 Point Likert Scale | -0.72 pain score | Standard Deviation 1.2 |
| Control | Average Change in Subjective Pain Level Using a 10 Point Likert Scale | 0.61 pain score | Standard Deviation 1.1 |
Secondary
Average Number of Physical Therapy Sessions Prior to Receiving Clearance by Physical Therapy Staff
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.
Time frame: Post-operative day 1 until clearance by physical staff (up to 60 days postoperatively)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Intervention | Average Number of Physical Therapy Sessions Prior to Receiving Clearance by Physical Therapy Staff | 3.2 sessions | Standard Deviation 1.7 |
| Control | Average Number of Physical Therapy Sessions Prior to Receiving Clearance by Physical Therapy Staff | 3.2 sessions | Standard Deviation 1.1 |
Secondary
Total Amount of Administered Opioids During the Post-operative Period
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.
Time frame: From post-operative day 1 until hospital discharge (up to 60 days postoperatively)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Virtual Reality Intervention | Total Amount of Administered Opioids During the Post-operative Period | 55.7 mg | Standard Deviation 31.7 |
| Control | Total Amount of Administered Opioids During the Post-operative Period | 49.9 mg | Standard Deviation 19.1 |