Effects of Virtual Reality on Perioperative Pediatric Anxiety

Study Overview
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Brief Summary
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This study evaluates the effect of virtual reality on anxiety levels in a pediatric surgical population. Half of participants will receive standard perioperative treatment, while the other half will receive additionally a virtual reality local program.

Detailed Description
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It is well known that there is a high incidence of significant anxiety in pediatric population perioperatively, with adverse side effects in terms of emergence delirium and maladaptive postoperative behaviors. Many different strategies have been designed in order to minimize these negative consequences. Virtual reality is a new and simple technology that can be used at young ages. The aim of this study is to measure anxiety levels at different times in children scheduled for ambulatory surgery compared to patients with standard care without virtual reality.

Official Title
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Effects of Virtual Reality on Perioperative Pediatric Anxiety

Conditions
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Preoperative Anxiety, Maladaptive Postoperative Behavior, Emergence Delirium

Intervention / Treatment
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* Device: Virtual Reality glasses
* Procedure: standard perioperative care without virtual reality program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child between 4 and 12 years old Elective ambulatory surgery Parents posses a smart phone Child and parents understand Spanish or Catalan Patient information has been explained Informed Consent is signed Surgery scheduled in the morning Exclusion Criteria: Child has hearing impairment Child has visual impairment Child has previous experience of anesthesia American Society os Anesthesiologists (ASA) score of III or greater Children with history of seizures Children under psychiatric treatment

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 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
Interventional Model Description: Prospective randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality program group<br>Virtual reality program based on a virtual reality guided tour registered in the investigator's pediatric OR setting before surgery. | Device: Virtual Reality glasses<br>* Children are encouraged to watch the virtual reality program at least 24 hours before surgery.<br>|
| Active Comparator: control group<br>standard perioperative care without virtual reality program | Procedure: standard perioperative care without virtual reality program<br>* standard perioperative care without virtual reality program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Anxiety level | In children: measured using the modified Yale Perioperative Anxiety Scale, blinded reported by a trained nurse before the patient is transferred to the operating room. Rage from 23.5 up to 100, deemed high anxiety level if test rated over 30 | baseline to 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary Cortisol level | In children: Saliva sample collection using Salivette system before the patient is transferred to the operating room. Levels over 8nmol/l can be caused by high anxiety level | baseline to 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, pediatric surgery