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Use of Virtual Reality for Pelvic External Fixator Removal

Primary Purpose

Pelvic Fracture Pubic Rami Multiple - Unstable Closed

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pelvic Fracture Pubic Rami Multiple - Unstable Closed

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington/Harborview Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Virtual Reality

Arm Description

Standard of care, no Virtual Reality

Standard of care plus Virtual Reality

Outcomes

Primary Outcome Measures

Pain Score
Pain score during removal of external fixator

Secondary Outcome Measures

Patient Satisfaction
Self reported patient satisfaction, comparing no virtual reality to virtual reality

Full Information

First Posted
December 15, 2019
Last Updated
December 15, 2019
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT04202315
Brief Title
Use of Virtual Reality for Pelvic External Fixator Removal
Official Title
Use of Virtual Reality for Pelvic External Fixator Removal
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Fracture Pubic Rami Multiple - Unstable Closed

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care, no Virtual Reality
Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Standard of care plus Virtual Reality
Intervention Type
Other
Intervention Name(s)
Virtual Reality
Intervention Description
Utilizing Virtual Reality during external fixator removal in outpatient clinic setting.
Primary Outcome Measure Information:
Title
Pain Score
Description
Pain score during removal of external fixator
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
Self reported patient satisfaction, comparing no virtual reality to virtual reality
Time Frame
immediately after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hunter Hoffman, PhD
Phone
2067442172
Email
hunthoff@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maryam Soltani, M.Ed
Phone
206-744-2172
Email
soltani@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Firoozabadi, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington/Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hunter Hoffman, PhD

12. IPD Sharing Statement

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Use of Virtual Reality for Pelvic External Fixator Removal

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