Virtual Reality Analgesia During Pediatric Physical Therapy (VRD/Peds)

We would like to determine whether Virtual Reality (VR) analgesia continues to be effective for reducing pain when administered for a clinically relevant treatment duration over multiple, repeated exposures (i.e., up to ten sessions of physical therapy per patient).

Study Overview

• Status: Completed
• Conditions: Burn
• Intervention / Treatment: Behavioral: VR during Physical Therapy; Behavioral: VR Background Pain; Behavioral: NO VR

Detailed Description

This study is done in a hospital for inpatients pediatrics. By randomization some subjects will immersive Virtual Reality (VR) during a painful procedure on daily basis up to 10 days to see whether this will reduce the pain and anxiety.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104-2499
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age greater than or equal to 8 years up to 20 yrs old
• Compliant and able to complete subject evaluation
• A minimum of 3 days of physical therapy, one physical therapy session per day
• No history of psychiatric (DSM-IV-R Axis I) or developmental disorder that would interfere with decisional capacity
• Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder that would interfere with decisional capacity
• Able to communicate verbally
• Able to take oral medications
• English-speaking

Exclusion Criteria:

• - Age less than 8 years, or greater than 20 years.
• Not capable of indicating pain intensity
• Not capable of filling out study measures
• Hospitalization of fewer than 3 days
• Evidence of traumatic brain injury
• History of psychiatric (DSM-IV-R Axis I) disorder as evidenced in the admitting RN and MD admission notes, if interfering with decisional capacity
• Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems that would interfere with decisional capacity
• Unable to communicate verbally
• Unable to take oral medications
• History of sig. cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal or genitourinary impairment that would interfere with treatment or decisional capacity
• Receiving prophylaxis for alcohol or drug withdrawal
• Developmental disability that would interfere with decisional capacity
• Face/head/neck injuries preventing helmet use
• Non-English-speaking
• Extreme susceptibility to motion sickness
• Seizure history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR during Physical Therapy; The subject will receive virtual reality during painful physical therapy sessions.	Behavioral: VR during Physical Therapy; Virtual Reality will be performed during a painful physical therapy procedure.
Experimental: VR background pain; The subjects receives virtual reality, not during a physical therapy procedure, another time of the day for background pain.	Behavioral: VR Background Pain; Virtual Reality is used at anytime during the day for the background pain, not during physical therapy.
Experimental: No VR; The subject will receive the usual standard treatment. At the end of the study, before being discharged from the hospital, the subject can experience the VR, not during a procedure.	Behavioral: NO VR; The subject will receive the usual standard treatment. At the end of the study, before being discharged from the hospital, the subject can experience the VR, not during a procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain and anxiety	pre and post procedure

Collaborators and Investigators

• Sponsor: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: David R Patterson, Ph.D., University of Washington

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: October 13, 2009
• First Submitted That Met QC Criteria: October 13, 2009
• First Posted (Estimate): October 14, 2009

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Virtual Reality Peds
• Other Study ID Numbers: 36154-C