Virtual Reality Analgesia During Pediatric Physical Therapy

NCT ID: NCT00993889

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2017-04-30

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).

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.

Conditions

Burn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VR during Physical Therapy

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

Group Type: EXPERIMENTAL

VR during Physical Therapy

Intervention Type: BEHAVIORAL

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

VR background pain

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

Group Type: EXPERIMENTAL

VR Background Pain

Intervention Type: BEHAVIORAL

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.

Group Type: EXPERIMENTAL

NO VR

Intervention Type: 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.

Interventions

VR during Physical Therapy

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

Intervention Type: BEHAVIORAL

VR Background Pain

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: lead

Responsible Party

David R. Patterson

PhD.ABPP. Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David R Patterson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

36154-C

Identifier Type: -

Identifier Source: org_study_id