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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 23, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention
Burn
Behavioral: VR during Physical Therapy
Behavioral: VR Background Pain
Behavioral: NO VR

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 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   5 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
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

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
Investigators
Principal Investigator: David R Patterson, Ph.D. University of Washington
  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: September 23, 2014
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 October 20, 2014