Virtual Reality for Postoperative Pain Management

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgery, Pain, Postoperative, Incision, Otolaryngological Disease

Intervention / Treatment
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* Device: Smartphone
* Device: Virtual Reality (Oculus Quest)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality