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

This study is currently recruiting participants.
Verified January 2011 by National Institute of General Medical Sciences (NIGMS)
Sponsor:
Information provided by (Responsible Party):
David R. Patterson, National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00993889
First received: October 13, 2009
Last updated: May 6, 2013
Last verified: January 2011
  Purpose

We would like to determine whether 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).


Condition Intervention
Burn
Behavioral: VR during PT
Behavioral: VR Background Pain

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Virtual Reality Analgesia During Pediatric Physical Therapy

Resource links provided by NLM:


Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Primary Outcome Measures:
  • Pain and anxiety [ Time Frame: pre and post procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Tech VR during PT Behavioral: VR during PT
High tech Virtual Reality will be performed during a painful physical therapy procedure.
Experimental: VR during PT Behavioral: VR during PT
Virtual Reality is performed during a painful physical therapy procedure.
Experimental: VR during background pain
VR background pain
Behavioral: VR Background Pain
Virtual Reality is used at anytime during the day just for the background pain.

  Eligibility

Ages Eligible for Study:   8 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993889

Locations
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104-2499
Contact: David R Patterson, Ph. D.    206-744-3418    davepatt@u.washington.edu   
Contact: Maryam Soltani, M.Ed    206-744-2172    soltani@u.washington.edu   
Principal Investigator: David R Patterson, Ph.D.         
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: David R. Patterson, PhD.ABPP. Professor, National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier: NCT00993889     History of Changes
Other Study ID Numbers: 36154-C
Study First Received: October 13, 2009
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Institute of General Medical Sciences (NIGMS):
Virtual Reality Peds

ClinicalTrials.gov processed this record on April 23, 2014