Virtual Reality for Postoperative Pain Management

Virtual Reality for Postoperative Pain Management After Head and Neck Surgery: A Randomized Controlled Trial

This trial studies an active virtual reality (VR) experience as a means for non-pharmacologic postoperative pain management among patients after head and neck surgery. Investigators will assess differences in pain scores, analgesic use, and subjective patient experiences between patients participating in a VR activity and patients participating in the same activity using a smartphone.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Surgery; Incision; Otolaryngological Disease
• Intervention / Treatment: Device: Virtual Reality (Oculus Quest); Device: Smartphone

Detailed Description

Management of postoperative pain after head and neck surgery is complex, and has received increased attention to improve patient recovery and quality of life. Narcotic analgesics are frequently utilized in postoperative pain management, but these have risks including nausea, sedation, constipation, and dependence. Multimodal analgesia can reduce narcotic use and improve recovery, but medical comorbidities may contraindicate the use of certain medications. Non-pharmacologic measures for postoperative pain control may provide novel and cost-effective strategies to confront this complex issue.

Patients undergoing head and neck surgery will be randomly allocated to participate in an immersive experience in VR, or to participate in a similar experience on a two-dimensional screen using a smartphone.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who have undergone head and neck surgery with an average pain score of 3 or greater out of 10 during the 24 hours preceding the screening
• Are able to provide informed consent
• Are not in the intensive care unit (ICU)

Exclusion Criteria:

• Symptoms concerning for an active respiratory infection including fever, cough, and shortness of breath or confirmed respiratory infection
• Active eye discharge
• Active nausea or vomiting
• History of seizure, epilepsy, or hypersensitivity to flashing light
• History of motion sickness or vertigo
• Have wound dressings on the head or neck that prevent comfortable and safe use of the virtual reality headset

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Virtual Reality; Patients will be provided with a commercially-available VR device for use up to 15 minutes at bedside.	Device: Virtual Reality (Oculus Quest); Patients will participate in a game using VR.
Sham Comparator: Smartphone; Patients will be provided with a commercially-available smartphone device for use up to 15 minutes at bedside.	Device: Smartphone; Patients will participate in a similar game to the VR cohort, but will use a smartphone device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient-reported pain scores	Pain scores will be obtained using an 11-point Numeric Rating Scale (NRS) prior to each intervention, immediately after the intervention, and then hourly up to 4 hours after the intervention to assess changes in pain scores after each intervention. A score of 0 signifies no pain, and a score of 10 signifies the highest severity of pain.	Up to 4 hours after intervention use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid usage	Opioid use after intervention will be documented, measured in average morphine milligram equivalents (MME).	Average 24 hours after intervention use
Patient experience	Patients will complete a short survey at the completion of their participation in the study evaluating their audiovisual experience using a 5-point Likert scale, with responses ranging from "1 = Strongly Disagree" to "5 = Strongly Agree."	Up to 4 hours after intervention use

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Publications and helpful links

General Publications

• Pandrangi VC, Shah SN, Bruening JD, Wax MK, Clayburgh D, Andersen PE, Li RJ. Effect of Virtual Reality on Pain Management and Opioid Use Among Hospitalized Patients After Head and Neck Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Aug 1;148(8):724-730. doi: 10.1001/jamaoto.2022.1121.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2020
• Primary Completion (Actual): October 20, 2021
• Study Completion (Actual): October 20, 2021

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Virtual Reality
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Otorhinolaryngologic Diseases
• Other Study ID Numbers: 00020777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No