Effects of Virtual Reality on Pre-Operative Anxiety and Induction of Anesthesia in Children and Adolescents

Study Overview
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Brief Summary
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Pain and anxiety have a direct correlation. Patients who experience anxiety are more susceptible to feeling pain, and patients who experience pain are more likely to have a component of anxiety associated with their pain. A common technique used by pain psychologists to help minimize pain is distraction. Different forms of distraction include video games, movies, music, etc. Recently, doctors and researchers around the world have begun experimenting with Virtual Reality as a distraction technique. A review of the use of virtual reality compared to the current standard of care may help uncover important trends regarding anxiety, postoperative pain and analgesic use in patients who undergo a tonsillectomy or a tonsillectomy and adenoidectomy.

Detailed Description
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There are approximately five million pediatric surgeries performed in the United States every year, and approximately 50% of pediatric patients experience significant stress and anxiety before their surgery. High anxiety can result in increased postoperative pain, increased analgesic consumption, and delayed recovery. The perception of pain can have a strong psychological component and can increase if the patient gives the area of injury constant attention. Thus, different distraction techniques have been utilized by pain psychologists to take the patient's attention away from the area of injury. Pharmacological intervention to treat preoperative anxiety in children has its own side-effect profile. Midazolam is a common medication used parentally, nasally, or orally to alleviate preoperative anxiety. However, there are many side-effects that are not always preventable. Reports of 3.8% of patients having paradoxical effects from midazolam have been documented, and delayed emergence is possible in surgeries of short duration. In addition, midazolam can also result in critical events perioperatively, such as airway obstruction and worsened nausea and vomiting. Non-pharmacological interventions could help avoid these complications, however, current studies do not show a viable alternative to a pharmacological interventions. Virtual Reality (VR) is a technology that allows individuals to experience a virtual world. VR initially began as a form of entertainment, but it has expanded its application into several other areas. Within the past 10 years, this type of technology has been applied clinically as a method of distraction for medical procedures such as chemotherapy, physical therapy, burn wound changes, and surgery. VR allows the patients to be immersed in an interactive world stimulating sights, sounds, and motion to help enhance the distraction from pain, ultimately reducing anxiety. A small validation study was conducted at the Virtual Reality Medical Center to test the usability and safety in patients with chronic pain. Patients were presented with pleasant relaxing scenes including natural areas like forests, beaches, and mountains, with relaxing and soothing effects to help mimic slowed breathing. Researchers in this study found that the pain distraction virtual environment (VE) was easy to use, had good stereo sound effects, and was immersive and interactive. They also found that patients experienced low levels of fatigue, headache, eyestrain, and nausea when using the VR device. No studies have involved VR in setting of anesthesia induction period and a non-pharmacological intervention for preoperative anxiety. A pilot study conducted by Wiederhold et al, tested 6 chronic pain patients using a head-mounted VR device. All six study participants reported a significant drop in pain while using the natural VE. Similarly, a study from the University of Washington found that children playing VR video games or navigating through a virtual environment while receiving wound care for their burns had lower pain scores than patients who just played video games. Another study conducted by Wiederhold et al., looked at fear and pain before and after dental treatment and found a significant decrease in pain perception and stated anxiety scores in patients using the VR eyeglasses compared to the nonuse group. Based on success in other medical procedures, we propose a study to examine the efficacy and feasibility of using VR during induction of anesthesia to help minimize anxiety, postoperative pain and analgesic use in patients undergoing a tonsillectomy or a tonsillectomy and adenoidectomy procedure.

Official Title
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A Pilot Study to Evaluate the Efficacy of Virtual Reality on Pre-Operative Anxiety and Induction of Anesthesia in a Children's Hospital

Conditions
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Tonsillectomy

Intervention / Treatment
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* Device: Virtual Reality
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient undergoing tonsillectomy or tonsillectomy and adenoidectomy procedure Must be between the ages of 5 and 11 years Anxious/moderate anxiety patients (mYPAS greater than or equal to 30) Exclusion Criteria: Any patient with preoperative peripherally placed IV Any patient who is cognitively impaired Any patient with a previous surgery ASA Physical Status higher than II Body Mass Index >30 A history of affective disorder, attention disorder, or psychotropic medication use Calm/low anxiety patients (mYPAS less than 30) Deaf or blind

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 11 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Group<br>Subjects will be given the virtual reality device to interact with prior to surgery without the use of a pre-medication. | Device: Virtual Reality<br>* Child will wear and interact with virtual reality headset while waiting for surgery.<br>* Other names: KindVR;|
| Active Comparator: Midazolam Group<br>Subjects will be given the drug Midazolam to help alleviate the pre-operative anxiety. | Drug: Midazolam<br>* Child will receive Midazolam to help with pre-operative anxiety prior to surgery<br>* Other names: Versed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-Operative Anxiety measured by mYPAS anxiety scores | Determine if the use of a VR device will result in lower mYPAS anxiety scores during the preoperative period | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction Compliance of Anesthesia measured by the induction compliance checklist | Determine if the use of a VR device will result in greater induction of anesthesia measured by the induction compliance checklist. | Baseline | 
| Post-Operative Emergence Delirium measured by the PAED scale | Determine if VR use will reduce incidence of post-operative emergence delirium measured by the PAED scale. | up to 3 hours post operative | 
| Post-Operative Pain | Measure if VR use will reduce post-operative pain scores compared to patients receiving standard of care. | up to 3 hours post operative | 
| Post-Operative Opioid Use | Measure VR use will reduce opioid use compared to patients receiving standard of care | up to 3 hours post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, adenoidectomy, induction of anesthesia, pre-operative anxiety