Virtual Reality Analgesia During Pediatric Physical Therapy

Burn Clinical Trial

— VRD/Peds  

Official title:

Virtual Reality Analgesia During Pediatric Physical Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993889
• Other study ID #: 36154-C
• Status: Completed
• Phase: N/A
• Start date: May 2009
• Est. completion date: April 2017

Study information

• Verified date: March 2019
• Source: National Institute of General Medical Sciences (NIGMS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn

Intervention

Behavioral:
• VR during Physical Therapy
Virtual Reality will be performed during a painful physical therapy procedure.
• VR Background Pain
Virtual Reality is used at anytime during the day for the background pain, not during physical therapy.
• 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.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain and anxiety		pre and post procedure