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Virtual Reality Pain Control Orthopedic Trauma

Controling Pain After Orthopedic Trauma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02100163
Acronym
VROT
Enrollment
211
Registered
2014-03-31
Start date
2014-03-31
Completion date
2018-06-24
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma/Injury Problem

Keywords

Ortho trauma. Virtual Reality. Pain. Anxiety

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.

Interventions

The patient receives virtual reality hypnosis daily.

BEHAVIORALAudio Hypnosis

Patient will listen to an Audio Hypnosis recording daily.

OTHERStandard treatment

Sponsors

National Institute of General Medical Sciences (NIGMS)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Graphic Rating Scale (GRS) pain and anxiety Questionnaireup to 10 daysMeasures pain and anxiety

Secondary

MeasureTime frameDescription
Tellegen Absorption Scale1 day (Once in the hospital)consists of 34 true-false items that examines hypnotic susceptibility in individuals

Other

MeasureTime frameDescription
The Short Stanford Hypnotizability Scale (SSHS)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.
SF-361 day (Once in the hospital)self-reported survey to measure health status and quality of life
Brief Symptom Inventory1 day (Once in the hospital)self-reported instrument that measures the current overview of psychological symptoms and their intensity

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026