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OpenTrials
Completed

NCT Number: NCT02100163

Virtual Reality Pain Control 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.

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Key information

Conditions

Trauma/Injury Problem Accidental Injuries Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Hypnosis

Behavioral

The patient receives virtual reality hypnosis daily.

Other names: VRH

Audio Hypnosis

Behavioral

Patient will listen to an Audio Hypnosis recording daily.

standard treatment

Other

Other names: Tere are no interventions

Primary outcomes

  1. Graphic Rating Scale (GRS) pain and anxiety Questionnaire

    Time frame: up to 10 days

    Measures pain and anxiety

Secondary outcomes

  1. Tellegen Absorption Scale

    Time frame: 1 day (Once in the hospital)

    consists of 34 true-false items that examines hypnotic susceptibility in individuals

Other outcomes

  1. The Short Stanford Hypnotizability Scale (SSHS)

    Time frame: 1 day (Once in the hospital)

    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.

  2. SF-36

    Time frame: 1 day (Once in the hospital)

    self-reported survey to measure health status and quality of life

  3. Brief Symptom Inventory

    Time frame: 1 day (Once in the hospital)

    self-reported instrument that measures the current overview of psychological symptoms and their intensity

Sponsors and collaborators

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Nih

Registry information

Official study title

Controling Pain After Orthopedic Trauma

Acronym: VROT

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 31, 2014
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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