NCT04202315

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

1.4 years

First QC Date

December 15, 2019

Last Update Submit

December 15, 2019

Conditions

Pelvic Fracture Pubic Rami Multiple - Unstable Closed

Outcome Measures

Primary Outcomes (1)

  • Pain Score

    Pain score during removal of external fixator

    During procedure

Secondary Outcomes (1)

  • Patient Satisfaction

    immediately after procedure

Study Arms (2)

Control

NO INTERVENTION

Standard of care, no Virtual Reality

Virtual Reality

EXPERIMENTAL

Standard of care plus Virtual Reality

Other: Virtual Reality

Interventions

Virtual RealityOTHER

Utilizing Virtual Reality during external fixator removal in outpatient clinic setting.

Virtual Reality

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Infected pin or pins
  • Loose pin or pins
  • Psych history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington/Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

Study Officials

  • Reza Firoozabadi, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hunter Hoffman, PhD

CONTACT

2067442172hunthoff@uw.edu

Maryam Soltani, M.Ed

CONTACT

206-744-2172soltani@uw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, School of Medicine: Orthopaedics and Sports Medicine

Study Record Dates

First Submitted

December 15, 2019

First Posted

December 17, 2019

Study Start

January 15, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

December 17, 2019

Record last verified: 2019-12

Locations

US(1)