Virtual Reality Pain Control Orthopedic Trauma

Trauma/Injury Problem Clinical Trial

— VROT  

Official title:

Controling Pain After Orthopedic Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100163
• Other study ID #: 43654-J/001500
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: June 24, 2018

Study information

• Verified date: March 2019
• Source: National Institute of General Medical Sciences (NIGMS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: June 24, 2018
• Est. primary completion date: June 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Trauma/Injury Problem
• Wounds and Injuries

Intervention

Behavioral:
• Virtual Reality Hypnosis
The patient receives virtual reality hypnosis daily.
• Audio Hypnosis
Patient will listen to an Audio Hypnosis recording daily.

Other:
• Standard treatment

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Short Stanford Hypnotizability Scale (SSHS)	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.	1 day (Once in the hospital)
Other	SF-36	self-reported survey to measure health status and quality of life	1 day (Once in the hospital)
Other	Brief Symptom Inventory	self-reported instrument that measures the current overview of psychological symptoms and their intensity	1 day (Once in the hospital)
Primary	Graphic Rating Scale (GRS) pain and anxiety Questionnaire	Measures pain and anxiety	up to 10 days
Secondary	Tellegen Absorption Scale	consists of 34 true-false items that examines hypnotic susceptibility in individuals	1 day (Once in the hospital)