Adolescent Idiopathic ScoliosisNCT06101264
Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population
A study testing Virtual Reality in people with Adolescent Idiopathic Scoliosis, run by Connecticut Children's Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All pediatric patients (ages 13-18) at Connecticut Children's undergoing surgical correction for idiopathic scoliosis over a span of 12 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Control, Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDevice
Control patients following spinal fusion for adolescent idiopathic scoliosis that receive no virtual reality sessions.
Virtual RealityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Participants will receive a post-operative virtual reality intervention following corrective surgery for idiopathic scoliosis. Receives: Device: Virtual Reality |
| Control | Experimental | Patients not receiving virtual reality intervention following corrective surgery for idiopathic scoliosis. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 times daily postoperatively until hospital discharge (up to 60 days postoperatively)
Secondary outcomes (2)
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.
Measured: From post-operative day 1 until hospital discharge (up to 60 days postoperatively)
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.
Measured: Post-operative day 1 until clearance by physical staff (up to 60 days postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Jan 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut
- Responsible party
- Sponsor
- Investigators
- David Hersh, MD, Principal investigator, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101264
- Sponsor's protocol ID
- 23-064-CCMC
- Status last verified
- Sep 2025
- First submitted
- 16 Oct 2023
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population
- ClinicalTrials.gov ID
- NCT06101264
- Acronym / sponsor ID
- 23-064-CCMC
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Collaborators
- University of Connecticut
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Virtual RealityParticipants will receive a post-operative virtual reality intervention following corrective surgery for idiopathic scoliosis. |
| Control | Experimental | Device: ControlPatients not receiving virtual reality intervention following corrective surgery for idiopathic scoliosis. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All pediatric patients (ages 13-18) at Connecticut Children's undergoing surgical correction for idiopathic scoliosis over a span of 12 months
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlControl patients following spinal fusion for adolescent idiopathic scoliosis that receive no virtual reality sessions. | Device | Control |
| Virtual RealityPatients 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. | Device | Virtual Reality |
Primary outcome
Average Change in Subjective Pain Level Using a 10 Point Likert Scale
Time frame: 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.
2 secondary outcomes
Total Amount of Administered Opioids During the Post-operative Period
Time frame: From post-operative day 1 until hospital discharge (up to 60 days postoperatively)
Average Number of Physical Therapy Sessions Prior to Receiving Clearance by Physical Therapy Staff
Time frame: Post-operative day 1 until clearance by physical staff (up to 60 days postoperatively)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hersh, MD principal investigator
Connecticut Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Adolescent Idiopathic Scoliosis, run by Connecticut Children's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Change in Subjective Pain Level Using a 10 Point Likert Scale (time frame: 2 times daily postoperatively until hospital discharge (up to 60 days postoperatively)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.