Efficacy of a Preoperative Virtual Reality Intervention as a Paediatric Anxiety Improvement Strategy

Study Overview
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Brief Summary
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This study evaluate the effectiveness of the Virtual Reality Educational Program (RVEP) in the Paediatric Surgical Prehabilitation Unit to reduce the perioperative anxiety in children who undergo to elective surgery. Half of the patients will received the virtual reality program, and the other half will received de common treatment.

Detailed Description
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During preoperative time, anxiety is one of the most frequent problems in children, causing an important health problem as long with pain. In the surgical fields there are two especially stressful moments for the child, the first one is the parent´s separation, and the second is the anaesthetic induction, which in up to 42% of cases can be traumatic. Methods to treat paediatric anxiety have evolved in the last decades. Pharmacological therapy is one of the most used methods to treat anxiety in the immediate preoperative period, but complications and unwanted side effects are described. Due to this side effects, this study will evaluate the the effectiveness of the Virtual Reality Educational Program (RVEP) to reduce the perioperative anxiety in children.

Official Title
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Efficacy of a Preoperative Virtual Reality Intervention as a Paediatric Anxiety Improvement Strategy

Conditions
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Anxiety, Virtual Reality

Intervention / Treatment
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* Device: Virtual Reality Educational Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 3 and 12 years old. Elective surgical intervention. ASA I-II (classification of the American Society of Anesthesiologists). Surgical complexity grade I-II according to National Institute for Clinical Excellence of the NHS. General anesthesia. Spanish or Catalan speaking families. Understanding the study and signing the informed consent of the study by parents or legal guardians. Exclusion Criteria: Patients suffering from psychiatric or mental illness, psychomotor retardation, blindness or deafness. Denial of parents / legal guardians and / or children. Ambulatory surgery. Surgical intervention of the child the year before the current one.

Ages Eligible for Study
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Minimum Age: 3 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Will visualize an Educational Virtual Reality video in preoperative period to reduce perioperative anxiety. | Device: Virtual Reality Educational Program<br>* The study group, in addition to providing the usual information about the anaesthetic-surgical process, will visualize an educational video through virtual reality glasses, of a maximum duration of 5 minutes. The video's explanation will be adapted according to the age ranges. Once the video is finished, if there aren't doubts, the visit will be concluded.<br>|
| No Intervention: Usual treatment<br>Will be applied the usual treatment (provide information on the anaesthetic-surgical process). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative Change of Paediatric Anxiety level | It will be measured by modified-Yale Preoperative Anxiety Scale (mYPAS) and its short form (mYPAS-SF). The mYPAS score range is: 23,3 to 100, majors scores indicate anxiety. It's considerate an anxiety cut-off point scores >40, and no anxiety <40. The mYPAS-SF score range is 22,7 to 100. | 3 days: 1.- On preanesthetic visit, using mYPAS scale. 2.- The surgery day, during parents separation, using mYPAS-SF. 3.- Postoperative day (24 hours after surgery), at hospitalization room, using a mYPAS scale. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paediatric pain | Measured by Faces Pain Rating Scale o Wong Baker Faces. It consist in 6 faces, The faces represent no harm to worse damage and the score goes from 0 to 10. | 2 days. The surgery day and the postoperative day (24 hours after surgery). | 
| Modified Aldrete postanesthetic recuperation | It is a hetero-administered scale consisting of 10 items. Each item responds to a Likert scale of 0 to 2, with a total range ranging from 0 to 10. The cut-off point is at 80% of the maximum score, ie 18 points suggest adequate recovery after anesthesia. | 1 day. The surgery day | 
| Parental satisfaction | Numeric Scale indicate 0= unsatisfied and 10= totally satisfied. | 1 day. At hospital discharge (24 hours after surgery). | 
| Resources | Will be measured using a self-created questionnaire. It contains variables as: Anaesthesia induction times (in minutes) Time between the surgery ends and recovery discharge (in minutes) Surgery times (in minutes) | 1 day. The surgery day. | 
| Children's collaboration during anaesthesia induction. | It will be measured by Induction Compliance Checklist (ICC). ICC score range is 0 to 10, 0 means collaborate and 10 no collaborate. | 1 day. The surgery day, during anaesthesia induction. | 
| Paediatric Delirium | Paediatric Anesthesia Emergence Delirium (PAED). It consists of 5 items with 5 possible answers on a scale of 0 to 4, with a score of > 10 indicating postsurgical agitation. | 2 days. The surgery day and the postoperative day (24 hours after surgery). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preanesthetic visit