Virtual Reality for Pain Management in Orthopaedic Patients

NCT04152447 | Completed Results FDA Device

• 1 other identifier: 2018P002763
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Investigators will determine the feasibility of a virtual reality pain control program (VR-PCP) as a non-pharmacologic adjunct for pain management while in the hospital (i.e. patient ability and willingness to use the system measured by average time spent on the device).
2. 2.Investigators will evaluate if there is a difference between the average daily use of opioid medications taken by patients who received usual care pain management versus patients using a VR-PCP.
3. 3.Investigators will assess for differences in short-term postoperative patient-reported pain intensity (PROMIS Patient Intensity v1.0) for patients who received usual care pain management versus those who also have access to a VR-PCP.

Conditions

Pain, Musculoskeletal

Outcome Measures

Primary Outcomes (1)

• Opioid Usage During the Postoperative Hospitalization

  Opioid usage during the postoperative hospitalization measured in average daily morphine milligram equivalents (MME). Higher number is a worse outcome.

  Post-operative period, an average of 3 days

Secondary Outcomes (2)

• Length of Stay

  Post-operative period, an average of 3 days

• Patient-reported Pain Scores

  Post-operative period, an average of 3 days

Study Arms (2)

Standard of care

NO INTERVENTION

This arm describes the standard protocol used to aid in orthopedic recovery.

VR device

ACTIVE COMPARATOR

Patients randomly assigned to the experimental arm of the study were provided an Oculus Go™ device for the duration of their hospitalization. The device featured a headset with a 1280 x 1440, 60 Hz refresh rate LCD display, spatial audio (via built-in speakers; headphones were not provided or used to our knowledge, despite compatibility) and the ability to track 3 degrees of rotational freedom; it was compatible with glasses and included a soft, adjustable strap for optimal, user-based fit. A single controller, capable of recognizing hand motion, pointing, and clicking was also included.

Device: VR device

Interventions

VR device DEVICE

Patients use a VR device

VR device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• and older
• Patients who sustained factures treated with open reduction internal fixation. Polytrauma patients whose fractures are definitively fixed in one discrete operating room visit will be included.

You may not qualify if:

• Cognitive impairment
• Injuries requiring staged surgical fixation (i.e. ex-fix to ORIF)
• Seizure disorder or other contraindication to VR usage
• Significant medical complications during hospitalization precluding use of a VR headset
• Significant surgical complication during hospitalization requiring unanticipated return to the operating room during index admission.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Orthopaedic Trauma Association: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Marilyn Heng
• Organization: Massachusetts General Hospital

mheng@mgh.harvard.edu

617-643-0149

Study Officials

• Marilyn Heng, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: November 5, 2019
• Study Start: August 29, 2019
• Primary Completion: November 13, 2020
• Study Completion: November 13, 2020
• Last Updated: February 15, 2022
• Results First Posted: February 15, 2022

Record last verified: 2022-02

Locations

US (1)