Virtual Reality Analgesia During Pediatric Physical Therapy

NCT00993889 | Completed

• 1 other identifier: 36154-C
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Burn

Keywords

Virtual Reality Peds

Outcome Measures

Primary Outcomes (1)

• Pain and anxiety

  pre and post procedure

Study Arms (3)

VR during Physical Therapy

EXPERIMENTAL

The subject will receive virtual reality during painful physical therapy sessions.

Behavioral: VR during Physical Therapy

VR background pain

EXPERIMENTAL

The subjects receives virtual reality, not during a physical therapy procedure, another time of the day for background pain.

Behavioral: VR Background Pain

No VR

EXPERIMENTAL

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

Interventions

VR during Physical Therapy BEHAVIORAL

Virtual Reality will be performed during a painful physical therapy procedure.

VR during Physical Therapy

VR Background Pain BEHAVIORAL

Virtual Reality is used at anytime during the day for the background pain, not during physical therapy.

VR background pain

NO VR BEHAVIORAL

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.

No VR

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• National Institute of General Medical Sciences (NIGMS): lead

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104-2499, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• David R Patterson, Ph.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD.ABPP. Professor

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: October 14, 2009
• Study Start: May 1, 2009
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

US (1)