Utilization of Different Virtual Reality Experiences

Study Overview
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Brief Summary
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This trial studies differences between a mindfulness and a gaming virtual reality (VR) experience as a means for preoperative anxiety management and postoperative pain management among patients after head and neck surgery. Investigators will assess differences in anxiety scores, pain scores, physiologic measures, and subjective patient experiences.

Detailed Description
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Optimal postoperative pain control after head and neck surgery is vital for recovery, and non-pharmacologic strategies to improve pain may help reduce narcotic use. Further, preoperative anxiety is common and can impact postoperative pain, analgesic requirements, and recovery. In addition to facilitating with postoperative pain control, VR may have a role in reducing preoperative anxiety. However, it is unclear whether different VR experiences may be more beneficial for different clinical applications. This study will evaluate if there are differences in preoperative anxiety and postoperative pain when utilizing different VR experiences. Patients undergoing head and neck surgery will be randomly allocated preoperatively to first participate in either a mindfulness or active gaming VR experience, and then postoperatively will crossover and participate in the other experience they did not utilize prior to surgery.

Official Title
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Impact of Different Virtual Reality Experiences on Anxiety and Pain

Conditions
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Surgery, Pain, Postoperative, Anxiety, Otolaryngological Disease

Intervention / Treatment
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* Device: Oculus Quest: TRIPP
* Device: Oculus Quest: Angry Birds


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing head and neck surgery Are able to provide informed consent Exclusion Criteria: Isolation precautions Active eye discharge Active nausea or vomiting History of seizure, epilepsy, or hypersensitivity to flashing light Expected to have wounds or wound care that prevent comfortable and safe use of the VR 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness Virtual Reality Experience<br>Patients will be provided with a mindfulness VR experience for use up to 15 minutes at bedside. | Device: Oculus Quest: TRIPP<br>* This is a VR experience that focuses on meditation and mindfulness<br>|
| Active Comparator: Gaming Virtual Reality Experience<br>Patients will be provided with an active gaming VR experience for use up to 15 minutes at bedside. | Device: Oculus Quest: Angry Birds<br>* This is an active gaming VR experience that utilizes controllers to aim and launch objects at targets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient-reported anxiety | Anxiety level will be obtained using a 100mm Visual Analogue Scale (VAS). Preoperative anxiety scores will be obtained prior to VR then immmediately after VR use to assess change in anxiety after each intervention. Score will range from 0 (no anxiety) to 100 (extremely anxious) | baseline, and then 15 minutes later after VR use | 
| Change in patient-reported pain | Pain level will be obtained using a 100mm Visual Analogue Scale (VAS). Postoperative pain scores will be obtained prior to VR then immmediately after VR use to assess change in pain level after each intervention. Score will range from 0 (no pain) to 100 (worst pain imaginable) | baseline, and then 15 minutes later after VR use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure | Blood pressure (mmHG) will be recorded prior to VR use and then after VR use to assess change in physiologic responses after each intervention. | baseline, and then 15 minutes later after VR use | 
| Patient experience | Patients will complete a short survey at the completion of their participation in each VR experience evaluating their experience using a 5-point Likert scale, with responses ranging from 1 (low satisfaction) to 5 (high satisfaction) | 1 minute after use of VR | 
| Change in heart rate | Heart rate (beats per minute [bpm]) will be recorded prior to VR use and then after VR use to assess change in physiologic responses after each intervention. | baseline, and then 15 minutes later after VR use |