NCT03584776

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

January 30, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

4.8 years

First QC Date

June 11, 2018

Last Update Submit

February 2, 2023

Conditions

Spinal Fusion

Keywords

Virtual reality

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    4 days

Secondary Outcomes (6)

  • Parents' Postoperative Pain Measure

    4 days

  • Faces Pain Scale-Revised

    4 days

  • Visual analogue scale

    4 days

  • Length of stay

    4 days

  • Pain assessment scores

    4 days

  • +1 more secondary outcomes

Study Arms (2)

Virtual Reality Post Spinal Fusion

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

Virtual RealityDEVICE

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.

Virtual Reality Post Spinal Fusion

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

Related Publications (30)

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  • Schmitt YS, Hoffman HG, Blough DK, Patterson DR, Jensen MP, Soltani M, Carrougher GJ, Nakamura D, Sharar SR. A randomized, controlled trial of immersive virtual reality analgesia, during physical therapy for pediatric burns. Burns. 2011 Feb;37(1):61-8. doi: 10.1016/j.burns.2010.07.007. Epub 2010 Aug 7.

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  • Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12.

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  • Hua Y, Qiu R, Yao WY, Zhang Q, Chen XL. The Effect of Virtual Reality Distraction on Pain Relief During Dressing Changes in Children with Chronic Wounds on Lower Limbs. Pain Manag Nurs. 2015 Oct;16(5):685-91. doi: 10.1016/j.pmn.2015.03.001. Epub 2015 May 9.

    PMID: 25972074BACKGROUND

  • Jones T, Moore T, Choo J. The Impact of Virtual Reality on Chronic Pain. PLoS One. 2016 Dec 20;11(12):e0167523. doi: 10.1371/journal.pone.0167523. eCollection 2016.

    PMID: 27997539BACKGROUND

  • Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13.

    PMID: 20691523BACKGROUND

  • Steele E, Grimmer K, Thomas B, Mulley B, Fulton I, Hoffman H. Virtual reality as a pediatric pain modulation technique: a case study. Cyberpsychol Behav. 2003 Dec;6(6):633-8. doi: 10.1089/109493103322725405.

    PMID: 14756928BACKGROUND

  • Cacau Lde A, Oliveira GU, Maynard LG, Araujo Filho AA, Silva WM Jr, Cerqueria Neto ML, Antoniolli AR, Santana-Filho VJ. The use of the virtual reality as intervention tool in the postoperative of cardiac surgery. Rev Bras Cir Cardiovasc. 2013 Jun;28(2):281-9. doi: 10.5935/1678-9741.20130039.

    PMID: 23939326BACKGROUND

  • Bieri D, Reeve RA, Champion DG, Addicoat L, Ziegler JB. The Faces Pain Scale for the self-assessment of the severity of pain experienced by children: development, initial validation, and preliminary investigation for ratio scale properties. Pain. 1990 May;41(2):139-150. doi: 10.1016/0304-3959(90)90018-9.

    PMID: 2367140BACKGROUND

  • Ramstad K, Jahnsen R, Skjeldal OH, Diseth TH. Characteristics of recurrent musculoskeletal pain in children with cerebral palsy aged 8 to 18 years. Dev Med Child Neurol. 2011 Nov;53(11):1013-8. doi: 10.1111/j.1469-8749.2011.04070.x.

    PMID: 22014321BACKGROUND

  • Hoffman HG, Patterson DR, Carrougher GJ. Use of virtual reality for adjunctive treatment of adult burn pain during physical therapy: a controlled study. Clin J Pain. 2000 Sep;16(3):244-50. doi: 10.1097/00002508-200009000-00010.

    PMID: 11014398BACKGROUND

  • Sharar SR, Miller W, Teeley A, Soltani M, Hoffman HG, Jensen MP, Patterson DR. Applications of virtual reality for pain management in burn-injured patients. Expert Rev Neurother. 2008 Nov;8(11):1667-74. doi: 10.1586/14737175.8.11.1667.

    PMID: 18986237BACKGROUND

  • Hoffman HG, Seibel EJ, Richards TL, Furness TA, Patterson DR, Sharar SR. Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. J Pain. 2006 Nov;7(11):843-50. doi: 10.1016/j.jpain.2006.04.006.

    PMID: 17074626BACKGROUND

  • Hoffman HG, Sharar SR, Coda B, Everett JJ, Ciol M, Richards T, Patterson DR. Manipulating presence influences the magnitude of virtual reality analgesia. Pain. 2004 Sep;111(1-2):162-8. doi: 10.1016/j.pain.2004.06.013.

    PMID: 15327820BACKGROUND

  • von Baeyer CL, Chambers CT, Eakins DM. Development of a 10-item short form of the parents' postoperative pain measure: the PPPM-SF. J Pain. 2011 Mar;12(3):401-6. doi: 10.1016/j.jpain.2010.10.002. Epub 2010 Dec 17.

    PMID: 21167790BACKGROUND

  • Chambers CT, Finley AG, McGrath PJ, Walsh TM. The parents' postoperative pain measure: replication and extension to 2-6-year-old children. Pain. 2003 Oct;105(3):437-443. doi: 10.1016/S0304-3959(03)00256-2.

    PMID: 14527704BACKGROUND

  • Hoffman HG, Richards TL, Coda B, Bills AR, Blough D, Richards AL, Sharar SR. Modulation of thermal pain-related brain activity with virtual reality: evidence from fMRI. Neuroreport. 2004 Jun 7;15(8):1245-8. doi: 10.1097/01.wnr.0000127826.73576.91.

    PMID: 15167542BACKGROUND

  • Wittwer A, Krummenacher P, La Marca R, Ehlert U, Folkers G. Salivary Alpha-Amylase Correlates with Subjective Heat Pain Perception. Pain Med. 2016 Jun;17(6):1131-6. doi: 10.1093/pm/pnv085. Epub 2016 Jan 13.

    PMID: 26764337BACKGROUND

  • Shinde SK, Danov S, Chen CC, Clary J, Harper V, Bodfish JW, Symons FJ. Convergent validity evidence for the Pain and Discomfort Scale (PADS) for pain assessment among adults with intellectual disability. Clin J Pain. 2014 Jun;30(6):536-43. doi: 10.1097/AJP.0000000000000020.

    PMID: 24135902BACKGROUND

  • Phan A, Edwards CL, Robinson EL. The assessment of pain and discomfort in individuals with mental retardation. Res Dev Disabil. 2005 Sep-Oct;26(5):433-9. doi: 10.1016/j.ridd.2004.10.001.

    PMID: 16039095BACKGROUND

  • Norton M, Holm JE, McSherry WC 2nd. Behavioral assessment of relaxation: the validity of a Behavioral Rating Scale. J Behav Ther Exp Psychiatry. 1997 Jun;28(2):129-37. doi: 10.1016/s0005-7916(97)00004-9.

    PMID: 9194010BACKGROUND

  • Pielech M, Ryan M, Logan D, Kaczynski K, White MT, Simons LE. Pain catastrophizing in children with chronic pain and their parents: proposed clinical reference points and reexamination of the Pain Catastrophizing Scale measure. Pain. 2014 Nov;155(11):2360-7. doi: 10.1016/j.pain.2014.08.035. Epub 2014 Aug 29.

    PMID: 25180013BACKGROUND

  • Breau LM, Camfield CS, McGrath PJ, Finley GA. The incidence of pain in children with severe cognitive impairments. Arch Pediatr Adolesc Med. 2003 Dec;157(12):1219-26. doi: 10.1001/archpedi.157.12.1219.

    PMID: 14662579BACKGROUND

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    PMID: 24308022BACKGROUND

  • Engel JM, Kartin D, Carter GT, Jensen MP, Jaffe KM. Pain in youths with neuromuscular disease. Am J Hosp Palliat Care. 2009 Oct-Nov;26(5):405-12. doi: 10.1177/1049909109346165.

    PMID: 19820205BACKGROUND

  • Symons FJ, Rivard PF, Nugent AC, Tervo RC. Parent evaluation of spasticity treatment in cerebral palsy using botulinum toxin type A. Arch Phys Med Rehabil. 2006 Dec;87(12):1658-60. doi: 10.1016/j.apmr.2006.08.343.

    PMID: 17141650BACKGROUND

  • Fernandez-Blazquez MA, Avila-Villanueva M, Lopez-Pina JA, Zea-Sevilla MA, Frades-Payo B. Psychometric properties of a new short version of the State-Trait Anxiety Inventory (STAI) for the assessment of anxiety in the elderly. Neurologia. 2015 Jul-Aug;30(6):352-8. doi: 10.1016/j.nrl.2013.12.015. Epub 2014 Jan 28. English, Spanish.

    PMID: 24484757BACKGROUND

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    PMID: 21876939BACKGROUND

Study Officials

  • Chantel Barney, PhD

    Gillette Children's Specialty Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2018

First Posted

July 12, 2018

Study Start

January 30, 2019

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

February 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)