NCT01823874

Brief Summary

Clinical benefits of VR analgesia have been empirically demonstrated as either an alternative or in combination with opioids. Issues of cost, ergonomics, and maintenance of the hardware systems have limited the wider use of this benefit to the public. Firsthand Technology has designed a system to meet the performance requirements for high levels of pain control in a durable, ergonomic package at a greatly reduced cost compared to the current systems in use. This study will validate the new system by running a thermal pain study that tests the effect of the new system (ID) compared to the established standard helmet currently used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

7 months

First QC Date

March 29, 2013

Last Update Submit

December 12, 2013

Conditions

Virtual Reality Pain Distraction

Keywords

Virtual reality analgesiapain control

Outcome Measures

Primary Outcomes (1)

  • Graphic Rating Scale pain ratings

    Rating scales will determine levels of pain, fun, and nausea experienced.

    immediately post test - Day 1.

Study Arms (2)

ID virtual reality distraction

EXPERIMENTAL

virtual reality distraction

Procedure: virtual reality distraction

HMD virtual reality distraction

EXPERIMENTAL

virtual reality distraction

Procedure: virtual reality distraction

Interventions

virtual reality distractionPROCEDURE

Pain distraction will be measured with both the HMD virtual reality method and the ID virtual reality method.

Also known as: HMD, ID
HMD virtual reality distractionID virtual reality distraction

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ages 18-39
  • healthy

You may not qualify if:

  • seizure disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Oral Medicine Clinic

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jacqueline E Pickrell, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

March 29, 2013

First Posted

April 4, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

December 16, 2013

Record last verified: 2013-12

Locations

US(1)