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Virtual Reality Pain Control Orthopedic Trauma (VROT)

N

National Institute of General Medical Sciences (NIGMS)

Status

Completed

Conditions

Trauma/Injury Problem

Treatments

Other: Standard treatment
Behavioral: Audio Hypnosis
Behavioral: Virtual Reality Hypnosis

Study type

Interventional

Funder types

NIH

Identifiers

NCT02100163
43654-J/001500

Details and patient eligibility

About

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.

Enrollment

211 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

211 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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