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Virtual Reality for Post-operative Pain Management

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ClinicalTrials.gov Identifier: NCT03584776
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Chantel Barney, Gillette Children's Specialty Healthcare

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Spinal Fusion Device: Virtual Reality Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of Virtual Reality for Pain Management in the Post-Operative Period Following Orthopedic Surgery
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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. Length of stay [ Time Frame: 4 days ]
    Length of inpatient stay following surgery (collected from medical record)

  5. Pain assessment scores [ Time Frame: 4 days ]
    Nursing pain assessment scores (collected from medical record)

  6. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584776


Contacts
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Contact: Chantel Barney, PhD 651-578-5205 CBarney@gillettechildrens.com
Contact: Lisa Lykken, BS 651-229-1768 lisalykken@gillettechildrens.com

Locations
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United States, Minnesota
Gillette Children's Specialty Healthcare Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Chantel Barney, PhD    651-724-8212    cbarney@gillettechildren.com   
Contact: Lisa Lykken, BS    651-229-1768    LisaALykken@gillettechildrens.com   
Sponsors and Collaborators
Gillette Children's Specialty Healthcare
Investigators
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Principal Investigator: Chantel Barney, PhD Gillette Children's Specialty Healthcare

Publications:

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Responsible Party: Chantel Barney, Principal Investigator, Gillette Children's Specialty Healthcare
ClinicalTrials.gov Identifier: NCT03584776     History of Changes
Other Study ID Numbers: STUDY00003725
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Chantel Barney, Gillette Children's Specialty Healthcare:
Virtual reality