NCT02100163

Brief Summary

The treatment of postoperative pain after severe trauma is poorly understood, and it can lead to chronic pain, opiate drug addiction and elevated health care costs. The proposed project will be a randomized controlled trial to evaluate an innovative methodology for delivering clinical hypnosis (virtual reality hypnosis) for pain control as well as a more time-honored delivery system that uses audio recordings. The goal will be to reduce postoperative pain in a sample of patients hospitalized for the care of severe orthopedic trauma and other types trauma. This proposal will test innovative and low-risk approaches to reducing postoperative trauma pain that are designed to reduce pain, anxiety and other complications after surgery. The findings have the potential not only to reduce pain and suffering in patients who have suffered severe trauma but could be applicable to the millions of people who have surgery every year. Reducing addictive opiate-based medication and health care costs are both potential outcomes from this project.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
211

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2018

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

4.3 years

First QC Date

March 19, 2014

Last Update Submit

March 11, 2019

Conditions

Trauma/Injury Problem

Keywords

Ortho trauma. Virtual Reality. Pain. Anxiety

Outcome Measures

Primary Outcomes (1)

  • Graphic Rating Scale (GRS) pain and anxiety Questionnaire

    Measures pain and anxiety

    up to 10 days

Secondary Outcomes (1)

  • Tellegen Absorption Scale

    1 day (Once in the hospital)

Other Outcomes (3)

  • The Short Stanford Hypnotizability Scale (SSHS)

    1 day (Once in the hospital)

  • SF-36

    1 day (Once in the hospital)

  • Brief Symptom Inventory

    1 day (Once in the hospital)

Study Arms (3)

Virtual Reality Hypnosis

EXPERIMENTAL

The patient receives VRH daily.

Behavioral: Virtual Reality Hypnosis

Audio Hypnosis

EXPERIMENTAL

The patient receives Audio Hypnosis daily.

Behavioral: Audio Hypnosis

Standard Treatment

EXPERIMENTAL

The patient receives the standard treatment. This is a control group and there are no interventions.

Other: Standard treatment

Interventions

Virtual Reality HypnosisBEHAVIORAL

The patient receives virtual reality hypnosis daily.

Also known as: VRH
Virtual Reality Hypnosis
Audio HypnosisBEHAVIORAL

Patient will listen to an Audio Hypnosis recording daily.

Audio Hypnosis
Standard treatmentOTHER
Also known as: Tere are no interventions
Standard Treatment

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Compliant and able to complete questionnaires
  • English speaking
  • Hospitalization for trauma orthopedic injuries
  • No history of psychiatric disorder
  • Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
  • Able to communicate verbally
  • years of age or older

You may not qualify if:

  • Not capable of filling out study measures
  • Evidence of a traumatic brain injury or any other
  • Cognitive deficits that would impact decisional capacity to consent for the
  • study or complete measures
  • History of psychiatric disorder as evidenced in the RN and MD admission notes
  • Unable to communicate verbally
  • Extreme susceptibility to motion sickness
  • Seizure history
  • Non-English speaking
  • In isolation for infections such as Clostridium difficile

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Accidental Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • David R. Patterson, Ph.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 31, 2014

Study Start

March 1, 2014

Primary Completion

June 24, 2018

Study Completion

June 24, 2018

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

US(1)