Virtual Reality Pain Control Orthopedic Trauma (VROT)

Controling Pain After Orthopedic Trauma

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.

Study Overview

• Status: Completed
• Conditions: Trauma/Injury Problem
• Intervention / Treatment: Behavioral: Virtual Reality Hypnosis; Behavioral: Audio Hypnosis; Other: Standard treatment

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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
• 18 years of age or older

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Hypnosis; The patient receives VRH daily.	Behavioral: Virtual Reality Hypnosis; The patient receives virtual reality hypnosis daily.; Other Names: VRH
Experimental: Audio Hypnosis; The patient receives Audio Hypnosis daily.	Behavioral: Audio Hypnosis; Patient will listen to an Audio Hypnosis recording daily.
Experimental: Standard Treatment; The patient receives the standard treatment. This is a control group and there are no interventions.	Other: Standard treatment; Other Names: Tere are no interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graphic Rating Scale (GRS) pain and anxiety Questionnaire	Measures pain and anxiety	up to 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tellegen Absorption Scale	consists of 34 true-false items that examines hypnotic susceptibility in individuals	1 day (Once in the hospital)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Short Stanford Hypnotizability Scale (SSHS)	assesses hypnotizability with five items: moving hands together motor suggestion, a dream within hypnosis, age regression, a posthypnotic suggestion of a cough, and posthypnotic amnesia.	1 day (Once in the hospital)
SF-36	self-reported survey to measure health status and quality of life	1 day (Once in the hospital)
Brief Symptom Inventory	self-reported instrument that measures the current overview of psychological symptoms and their intensity	1 day (Once in the hospital)

Collaborators and Investigators

• Sponsor: National Institute of General Medical Sciences (NIGMS)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): June 24, 2018
• Study Completion (Actual): June 24, 2018

Study Registration Dates

• First Submitted: March 19, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (Estimate): March 31, 2014

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Ortho trauma. Virtual Reality. Pain. Anxiety
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 43654-J/001500