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Clinical Trials/NCT04464304
NCT04464304
Completed
Not Applicable

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

Oregon Health and Science University1 site in 1 country30 target enrollmentJuly 11, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Oregon Health and Science University
Enrollment
30
Locations
1
Primary Endpoint
Change in patient-reported pain scores
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 11, 2020
End Date
October 20, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ryan Li, MD

Assistant Professor of Otolaryngology - Head and Neck Surgery, Division of Head and Neck Surgery, School of Medicine

Oregon Health and Science University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in patient-reported pain scores

Time Frame: Up to 4 hours after intervention use

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.

Secondary Outcomes

  • Opioid usage(Average 24 hours after intervention use)
  • Patient experience(Up to 4 hours after intervention use)

Study Sites (1)

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