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Virtual Reality Pain Control Orthopedic Trauma (VROT)

Primary Purpose

Trauma/Injury Problem

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Hypnosis
Audio Hypnosis
Standard treatment
Sponsored by
National Institute of General Medical Sciences (NIGMS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma/Injury Problem focused on measuring Ortho trauma. Virtual Reality. Pain. Anxiety

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Virtual Reality Hypnosis

Audio Hypnosis

Standard Treatment

Arm Description

The patient receives VRH daily.

The patient receives Audio Hypnosis daily.

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

Outcomes

Primary Outcome Measures

Graphic Rating Scale (GRS) pain and anxiety Questionnaire
Measures pain and anxiety

Secondary Outcome Measures

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

Full Information

First Posted
March 19, 2014
Last Updated
March 11, 2019
Sponsor
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT02100163
Brief Title
Virtual Reality Pain Control Orthopedic Trauma
Acronym
VROT
Official Title
Controling Pain After Orthopedic Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
June 24, 2018 (Actual)
Study Completion Date
June 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma/Injury Problem
Keywords
Ortho trauma. Virtual Reality. Pain. Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Hypnosis
Arm Type
Experimental
Arm Description
The patient receives VRH daily.
Arm Title
Audio Hypnosis
Arm Type
Experimental
Arm Description
The patient receives Audio Hypnosis daily.
Arm Title
Standard Treatment
Arm Type
Experimental
Arm Description
The patient receives the standard treatment. This is a control group and there are no interventions.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Hypnosis
Other Intervention Name(s)
VRH
Intervention Description
The patient receives virtual reality hypnosis daily.
Intervention Type
Behavioral
Intervention Name(s)
Audio Hypnosis
Intervention Description
Patient will listen to an Audio Hypnosis recording daily.
Intervention Type
Other
Intervention Name(s)
Standard treatment
Other Intervention Name(s)
Tere are no interventions
Primary Outcome Measure Information:
Title
Graphic Rating Scale (GRS) pain and anxiety Questionnaire
Description
Measures pain and anxiety
Time Frame
up to 10 days
Secondary Outcome Measure Information:
Title
Tellegen Absorption Scale
Description
consists of 34 true-false items that examines hypnotic susceptibility in individuals
Time Frame
1 day (Once in the hospital)
Other Pre-specified Outcome Measures:
Title
The Short Stanford Hypnotizability Scale (SSHS)
Description
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.
Time Frame
1 day (Once in the hospital)
Title
SF-36
Description
self-reported survey to measure health status and quality of life
Time Frame
1 day (Once in the hospital)
Title
Brief Symptom Inventory
Description
self-reported instrument that measures the current overview of psychological symptoms and their intensity
Time Frame
1 day (Once in the hospital)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Patterson, Ph.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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Virtual Reality Pain Control Orthopedic Trauma

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