Virtual Reality Pain Control Orthopedic Trauma

Study Overview
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Brief Summary
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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.

Official Title
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Controling Pain After Orthopedic Trauma

Conditions
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Trauma/Injury Problem

Intervention / Treatment
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* Behavioral: Virtual Reality Hypnosis
* Behavioral: Audio Hypnosis
* Other: Standard treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ortho trauma. Virtual Reality. Pain. Anxiety