Virtual Reality Pain Control Orthopedic Trauma

NCT ID: NCT02100163

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2018-06-24

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.

Conditions

Trauma/Injury Problem

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Hypnosis

The patient receives VRH daily.

Group Type: EXPERIMENTAL

Virtual Reality Hypnosis

Intervention Type: BEHAVIORAL

The patient receives virtual reality hypnosis daily.

Audio Hypnosis

The patient receives Audio Hypnosis daily.

Group Type: EXPERIMENTAL

Audio Hypnosis

Intervention Type: BEHAVIORAL

Patient will listen to an Audio Hypnosis recording daily.

Standard Treatment

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

Group Type: EXPERIMENTAL

Standard treatment

Intervention Type: OTHER

Interventions

Virtual Reality Hypnosis

The patient receives virtual reality hypnosis daily.

Intervention Type: BEHAVIORAL

Audio Hypnosis

Patient will listen to an Audio Hypnosis recording daily.

Intervention Type: BEHAVIORAL

Standard treatment

Intervention Type: OTHER

Other Intervention Names

VRH; Tere are no interventions

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: lead

Responsible Party

David R. Patterson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David R. Patterson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

43654-J/001500

Identifier Type: -

Identifier Source: org_study_id