NCT01099657

Brief Summary

We would like to determine how well hypnosis works when induced through virtual reality medium for patients who have suffered a major burn injury in the past two years and suffer from chronic pain. These patients are coming back to the outpatient burn and plastic clinic at Harborview Medical Center for routine follow-up. We think that patients will find VR-Hypnosis interesting, and it will help them relax and feel less pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2007

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

4.9 years

First QC Date

April 1, 2010

Last Update Submit

May 10, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain and anxiety

    The subjects will answer questions regarding pain and anxiety at the time of their clinic visit, before and after experiencing virtual reality. Then the subject will be followed for up to one month.

    pre and post VR and then up to one month

Study Arms (2)

Virtual Reality Hypnosis

EXPERIMENTAL

Virtual Reality Hypnosis for chronic pain

Behavioral: Virtual Reality Hypnosis for chronic pain

Virtual Reality Distraction

EXPERIMENTAL

Virtual Reality Distraction for Chronic Pain

Behavioral: Virtual Reality Distraction for Chronic Pain

Interventions

At the time of their clinic visit,the subject will answer pain and anxiety questionnaires before experiencing Virtual Reality Hypnosis. After VRH, the will again answer Pain and anxiety questionnaires.

Virtual Reality Hypnosis

At the time of their clinic visit,the subject will answer pain and anxiety questionnaires before experiencing Virtual Reality Distraction. After VRD, the will again answer Pain and anxiety questionnaires.

Virtual Reality Distraction

Eligibility Criteria

Age13 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 13 - 75 years
  • Able to complete subjective evaluations of pain
  • English-speaking
  • Able to communicate orally

You may not qualify if:

  • Age less than 13 years or greater than 75 years
  • Incapable of indicating subjective evaluation of pain
  • Non-English-speaking (Virtual Reality Hypnosis only available in English)
  • Demonstrating delirium, psychosis, or Organic Brain Disorder
  • Unable to communicate verbally
  • Significant developmental disability
  • Extreme susceptibility to motion sickness
  • Significant head/or neck injury
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Rehabilitative Medicine

Study Record Dates

First Submitted

April 1, 2010

First Posted

April 7, 2010

Study Start

June 1, 2007

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 12, 2017

Record last verified: 2017-05

Locations