Virtual Reality Pain Control Orthopedic Trauma

Not Applicable

Completed

• Conditions: Trauma/Injury Problem
• Interventions: Other: Standard treatment; Behavioral: Audio Hypnosis; Behavioral: Virtual Reality Hypnosis

• Registration Number: NCT02100163
• Lead Sponsor: National Institute of General Medical Sciences (NIGMS)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-31
• Primary Completion: 2018-06-24
• Study Completion: 2018-06-24
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Standard Treatment	Standard treatment	The patient receives the standard treatment. This is a control group and there are no interventions.
Audio Hypnosis	Audio Hypnosis	The patient receives Audio Hypnosis daily.
Virtual Reality Hypnosis	Virtual Reality Hypnosis	The patient receives VRH daily.

Primary Outcome Measures

Name	Time	Method
Graphic Rating Scale (GRS) pain and anxiety Questionnaire	up to 10 days	Measures pain and anxiety

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States