Use of Virtual Reality for Pelvic External Fixator Removal | NCT04202315

Studies
Use of Virtual Reality for Pelvic External Fixator Removal

NCT04202315

Sponsor

University of Washington

Status

Unknown status

Last Update Posted

Dec 17, 2019Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Pelvic Fracture Pubic Rami Multiple - Unstable Closed

Interventions

Virtual Reality

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

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2019Actual

Primary Completion Date

Jun 1, 2020Estimated

Completion Date

Jun 1, 2020Estimated

First Submitted Date

Dec 15, 2019

First Submission Date that Met QC Criteria

Dec 15, 2019

First Posted Date

Dec 17, 2019Actual

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

Dec 15, 2019

Last Update Posted Date

Dec 17, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Reza Firoozabadi, Associate Professor, School of Medicine: Orthopaedics and Sports Medicine, University of WashingtonPrincipal Investigator

Lead Sponsor

University of WashingtonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Assessing the role of virtual reality in decreasing pain and improving patient satisfaction in outpatient removal of pelvic external fixator constructs.

Detailed Description

Not provided

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Standard of care, no Virtual Reality
Virtual Reality	Experimental	Standard of care plus Virtual Reality	Other: Virtual Reality

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual Reality	Other	Utilizing Virtual Reality during external fixator removal in outpatient clinic setting.	Virtual Reality

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain Score	Pain score during removal of external fixator	During procedure

Secondary Outcomes

Measure	Description	Time Frame
Patient Satisfaction	Self reported patient satisfaction, comparing no virtual reality to virtual reality	immediately after procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pelvis external fixator placed at study institution
External fixator placed for pelvic instability

Exclusion Criteria:

Infected pin or pins
Loose pin or pins
Psych history

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hunter Hoffman, PhD	Contact	2067442172		hunthoff@uw.edu
Maryam Soltani, M.Ed	Contact	206-744-2172		soltani@uw.edu

Overall Officials

Name	Affiliation	Role
Reza Firoozabadi, MD	University of Washington	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Washington/Harborview Medical Center	Recruiting	Seattle	Washington	98104	United States