Virtual Reality for Postoperative Pain Management

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464304
• Other study ID #: 00020777
• Status: Completed
• Phase: N/A
• Start date: July 11, 2020
• Est. completion date: October 20, 2021

Study information

• Verified date: October 2021
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 20, 2021
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Incision
• Otolaryngological Disease
• Otorhinolaryngologic Diseases
• Pain, Postoperative
• Surgery

Intervention

Device:
• Smartphone
Patients will participate in a similar game to the VR cohort, but will use a smartphone device.
• Virtual Reality (Oculus Quest)
Patients will participate in a game using VR.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Opioid usage	Opioid use after intervention will be documented, measured in average morphine milligram equivalents (MME).	Average 24 hours after intervention use
Secondary	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