NCT04901793

Brief Summary

To prospectively determine if pediatric patients undergoing orthopedic procedures can benefit from employing virtual reality for pain management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
Last Updated

May 26, 2021

Status Verified

June 1, 2019

Enrollment Period

9 months

First QC Date

May 20, 2021

Last Update Submit

May 20, 2021

Conditions

Orthopedic DisorderFractures, Bone

Outcome Measures

Primary Outcomes (1)

  • Change in Heart Rate

    Change from baseline max HR to intra-procedural max HR

    Baseline HR measured 2 minutes pre-operation. Procedural HR measured during procedure.

Secondary Outcomes (2)

  • Perceived Anxiety

    measured within 5 minutes of procedure completion

  • Perceived Pain

    measured within 5 minutes of procedure completion

Study Arms (2)

Virtual Reality Intervention Group

EXPERIMENTAL

Patient is fitted with a Virtual Reality headset and handheld remote control. Subject is able to play an interactive game during the duration of the in-office procedure.

Behavioral: Virtual Reality Headset and handheld remote control.

Control Group

NO INTERVENTION

standard of care

Interventions

Virtual Reality Headset and handheld remote control.BEHAVIORAL

Brand name: Oculus Quest

Virtual Reality Intervention Group

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Presented for an in-office procedure after a primary orthopedic injury
  • Willing to participate in the study.
  • Between age of 5 and 18

You may not qualify if:

  • Any condition limiting subject ability to perceive and communicate information including developmental delay, Cerebral Palsy, or Autism Spectrum Disorder.
  • Limitations in subject ability to use the VR system including an inability to sit upright or bilateral upper extremity injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Health Center

Jefferson, Louisiana, 70121, United States

Location

Related Publications (6)

  • Koller D, Goldman RD. Distraction techniques for children undergoing procedures: a critical review of pediatric research. J Pediatr Nurs. 2012 Dec;27(6):652-81. doi: 10.1016/j.pedn.2011.08.001. Epub 2011 Oct 13.

    PMID: 21925588BACKGROUND

  • 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

  • Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.

    PMID: 16640481BACKGROUND

  • Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.

    PMID: 21779307BACKGROUND

  • Miller K, Rodger S, Bucolo S, Wang XQ, Kimble RM. [Multimodal distraction to relieve pain in children undergoing acute medical procedures]. Zhonghua Shao Shang Za Zhi. 2009 Oct;25(5):352-6. Chinese.

    PMID: 19951557BACKGROUND

  • Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.

    PMID: 29053848BACKGROUND

MeSH Terms

Conditions

Musculoskeletal DiseasesFractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Sean Waldron, MD

    Ochsner Health System

    PRINCIPAL INVESTIGATOR

  • Lawrence Haber, MD

    Ochsner Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A non-blinded computer-randomized prospective trial with two parallel study groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 26, 2021

Study Start

July 1, 2019

Primary Completion

March 16, 2020

Study Completion

March 16, 2020

Last Updated

May 26, 2021

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)