Virtual Reality for Post-operative Pain Management

February 2, 2023 updated by: Chantel Burkitt, Gillette Children's Specialty Healthcare

A Randomized Controlled Trial of Virtual Reality for Pain Management in the Post-Operative Period Following Orthopedic Surgery

Use an 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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Gillette Children's Specialty Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is having a spinal fusion at Gillette Children's Specialty Healthcare
  • Patient with a diagnosis of adolescent idiopathic scoliosis (AIS) or a diagnosis of neuromuscular scoliosis

Exclusion Criteria:

  • Non-English speaking parents/patients
  • Patients with history of motion sickness
  • Patients with epilepsy
  • Patients with a ventricular shunt
  • Patients with severe/profound cognitive impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Virtual Reality Post Spinal Fusion
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
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.
NO_INTERVENTION: Standard of Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timing of pain medication
Time Frame: 4 days
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.
4 days
Doses of pain medication
Time Frame: 4 days
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.
4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parents' Postoperative Pain Measure
Time Frame: 4 days
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.
4 days
Faces Pain Scale-Revised
Time Frame: 4 days
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.
4 days
Visual analogue scale
Time Frame: 4 days
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.
4 days
Length of stay
Time Frame: 4 days
Length of inpatient stay following surgery (collected from medical record)
4 days
Pain assessment scores
Time Frame: 4 days
Nursing pain assessment scores (collected from medical record)
4 days
Time patient out of bed
Time Frame: 4 days
Duration of time from surgery to patient out of bed and walking (collected from medical record).
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gillette Children's Specialty Healthcare

Investigators

  • Principal Investigator: Chantel Barney, PhD, Gillette Children's Specialty Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 30, 2019

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

June 11, 2018

First Submitted That Met QC Criteria

June 29, 2018

First Posted (ACTUAL)

July 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00003725

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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