An interventional study of Virtual Reality in Spinal Fusion, sponsored by Gillette Children's Specialty Healthcare. Completed at 1 site in United States. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Gillette Children's Specialty Healthcare · Not applicable, Interventional, and Supportive care
Use a randomized controlled trial (RCT) study design to measure pain experience, medication use, medical side effects, and length of hospital stay with and without availability of VR following spine fusion surgery
The purpose of this study is to prospectively assess the utility of virtual reality (VR) for pain and anxiety management in the post-operative period following major orthopedic surgery. While there is substantial evidence supporting the use of VR during dressing changes for burn victims, there is little known about VR use in post-surgical settings. In the proposed study, patients will be randomized to either receive VR in addition to standard of care or to receive only standard of care during their post-operative care following spinal fusion surgery for idiopathic scoliosis or neuromuscular scoliosis.
Gillette Children's Specialty Healthcare is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients randomized to the VR group will have the opportunity to utilize VR during the post operative period, and will also experience VR during research visits each day following surgery.
Device: Virtual Reality
Patients randomized to the non-VR condition will experience the usual standard of care following spinal fusion surgery. This will include 15-30 minutes of movie viewing during research visits.
Participants randomized to the VR condition will experience an an immersive guided relaxation VR experience during research visits in the post-operative period. They will also have the opportunity to choose additional VR games and relaxation experiences during their inpatient stay.
Timing of pain medication
Timing of morphine equivalent opioids (mg/kg/day) and adjunctive medications (e.g., Tylenol, Diazepam, Propofol, Midazolam, etc.; mg/kg/day).This will be collected retrospectively from the patient medical record following the conclusion of treatment.
Time frame: 4 days
Doses of pain medication
Doses of morphine equivalent opioids (mg/kg/day) and adjunctive medications (e.g., Tylenol, Diazepam, Propofol, Midazolam, etc.; mg/kg/day).This will be collected retrospectively from the patient medical record following the conclusion of treatment.
Time frame: 4 days
Parents' Postoperative Pain Measure
The Parents' Postoperative Pain Measure (PPPM-SF) is a measure of pain-related behavioral changes. The PPPM-SF is 10 question yes/no scale, covering functional interference (5 items) and pain behaviors (5 items) and asks parents to compare the child's behaviors with their typical behavior. Each score of "yes" is counted as 1-point, yielding a total score of 0-10 (higher scores indicating higher pain intensity). Parents will complete this measure daily until their child is discharged from the hospital.
Time frame: 4 days
Faces Pain Scale-Revised
The Faces Pain Scale-Revised (FPS-R) will be used to assess pain intensity in the post-operative period (for 1-6 days, depending on the length of inpatient stay) for the purposes of this study. The FPS-R will be used to assess pain intensity (faces indicating 0-10 pain scale, 0 face indicating no pain, 10 equals very much pain) "right now" and will be completed by the patient and parent (when present) at the beginning of each daily research visit for both the VR and non-VR groups. The VR group will complete the FPS-R again following the research facilitated VR session. For consistency purposes, parents will also be asked to report their perception of the patient's pain using the FPS-R.
Time frame: 4 days
Visual analogue scale
A visual analogue scale (VAS) will be used to quantify multiple aspects of the treatment experience expected to be impacted by the use of VR. The VAS will be a 10 cm 0-100 scale (0 indicating no pain, 100 indicating very much pain), will be completed once per day by both the VR and non-VR groups, and will reflect the past 24 hour period. Participants and their parents in the VR condition will complete the VAS a second time each day following the research facilitated VR experience (second VAS will reflect the past 15 minutes). The VAS will assess the following: patient anxiety; parent anxiety; patient and parent time spent thinking about pain; pain unpleasantness; average pain rating; pain rating right now; worst pain rating; least pain rating; engagement during VR (VR group only); and satisfaction with pain management.
Time frame: 4 days
Length of stay
Length of inpatient stay following surgery (collected from medical record)
Time frame: 4 days
Pain assessment scores
Nursing pain assessment scores (collected from medical record)
Time frame: 4 days
Time patient out of bed
Duration of time from surgery to patient out of bed and walking (collected from medical record).
Time frame: 4 days
Plan to share: No
Ran from Jan 2019 to primary completion in Nov 2022, 45 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion Dec 2023 → Nov 2022 and completion Dec 2024 → Nov 2022.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Gillette Children's Specialty Healthcare