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| Name | Class |
|---|---|
| University of Connecticut | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality | Experimental | Participants will receive a post-operative virtual reality intervention following corrective surgery for idiopathic scoliosis. |
|
| Control | Experimental | Patients not receiving virtual reality intervention following corrective surgery for idiopathic scoliosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Device | Control patients following spinal fusion for adolescent idiopathic scoliosis that receive no virtual reality sessions. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 times daily postoperatively until hospital discharge (up to 60 days postoperatively) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From post-operative day 1 until hospital discharge (up to 60 days postoperatively) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Hersh, MD | Connecticut Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | Patients that underwent spinal fusion for adolescent idiopathic scoliosis but did not receive virtual reality interventions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | pain score | 2 times daily postoperatively until hospital discharge (up to 60 days postoperatively) |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Non-systematic Assessment |
This study allocation of patients to the control group if they declined participation in the virtual reality sessions and is such not a true randomized controlled trial. Further, our prospective study has a small sample size as it is intended as a pilot study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prabhath Mannam | University of Connecticut School of Medicine | 8607092371 | pmannam@uchc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2024 | May 29, 2025 | Prot_SAP_000.pdf |
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| Virtual Reality | Device | 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. |
|
| 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. | Post-operative day 1 until clearance by physical staff (up to 60 days postoperatively) |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | 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, |
|
|
| 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. | Posted | Mean | Standard Deviation | mg | From post-operative day 1 until hospital discharge (up to 60 days postoperatively) |
|
|
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| 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. | Posted | Mean | Standard Deviation | sessions | Post-operative day 1 until clearance by physical staff (up to 60 days postoperatively) |
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| 0 |
| 10 |
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | Control | Patients that underwent corrective surgery for idiopathic scoliosis but did not undergo virtual reality sessions. | 0 | 10 | 0 | 10 | 0 | 10 |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Eye Strain | Eye disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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