Virtual Reality Analgesia During Pediatric Physical Therapy | NCT00993889

Studies
Virtual Reality Analgesia During Pediatric Physical Therapy

NCT00993889

Sponsor

National Institute of General Medical Sciences (NIGMS)

Status

Completed

Last Update Posted

Mar 13, 2019Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Burn

Interventions

VR during Physical Therapy
VR Background Pain
NO VR

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

Oct 13, 2009

First Submission Date that Met QC Criteria

Oct 13, 2009

First Posted Date

Oct 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2019

Last Update Posted Date

Mar 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
VR during Physical Therapy	Behavioral	Virtual Reality will be performed during a painful physical therapy procedure.	VR during Physical Therapy

Measure	Description	Time Frame
Pain and anxiety		pre and post procedure

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided