Pediatric Preoperative Virtual Reality Program

Study Overview
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Brief Summary
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Does the introduction of a preparatory virtual reality (VR) program that is used in the home environment, have an effect on the anxiety level of children immediately before surgery, prior to administration of preoperative sedatives?

Detailed Description
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Up to 60% of children who require elective surgery report significant anxiety in the preoperative setting. Severe perioperative anxiety of a child poses a major challenge for the surgeon, since it is often accompanied by adverse behavioral and emotional reactions and associated with a complicated operative and postoperative course. The investigators have made the personal experience that informing the children ahead of time about what to expect in the hospital, decreases child anxiety and increases parent satisfaction. There is considerable debate on the best way how to inform children about what to expect during their hospital stay. The investigators had a virtual reality application developed that introduces the children to several aspects of the hospital environment. Therefore, these children now ahead of time what they will experience during their hospital stay. The aim is to evaluate the effect of this preparatory virtual reality application on the anxiety level of children immediately before surgery.

Official Title
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The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery

Conditions
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Surgery, Anxiety

Intervention / Treatment
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* Other: Pre-Operative Preparatory Virtual Reality Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The child is between the age of 7 and 13 years The child is undergoing an elective surgical procedure under general anesthesia The child understands Swiss German The parent(s) understand(s) German The parent(s) possess a smart phone Internet access is given The patient information has been explained Informed Consent is signed Exclusion Criteria: The child has a hearing impairment The child has neurologic disorder The child requires postoperative intensive care The child has previous experience of anesthesia American Society of Anesthesiologists (ASA) score of III or greater

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized, controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orthopaedic Intervention group<br>In addition to the written and oral preparation for surgery this arm receives an 'on-boarding' package containing a cardboard VR, a code to download the VR App and a plush penguin. | Other: Pre-Operative Preparatory Virtual Reality Program<br>* The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery<br>|
| No Intervention: Orthopaedic Control group<br>Gets written and oral preparation for surgery | |
| Experimental: Urologic Intervention group<br>In addition to the written and oral preparation for surgery this arm receives an 'on-boarding' package containing a cardboard VR, a code to download the VR App and a plush penguin. | Other: Pre-Operative Preparatory Virtual Reality Program<br>* The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery<br>|
| No Intervention: Urologic Control group<br>Gets written and oral preparation for surgery | |
| Experimental: General Paediatric Surgery Intervention group<br>In addition to the written and oral preparation for surgery this arm receives an 'on-boarding' package containing a cardboard VR, a code to download the VR App and a plush penguin. | Other: Pre-Operative Preparatory Virtual Reality Program<br>* The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery<br>|
| No Intervention: General Paediatric Surgery Control group<br>Gets written and oral preparation for surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative anxiety level of children immediately before surgery (VAS-A) | Perioperative anxiety level of children as measured by the Visual Analog Scale for Anxiety (VAS-A), immediately before surgery, prior to administration of preoperative sedatives (T2). The VAS-A scale consists of a 10 cm long, horizontal line, supplemented by two labels: no anxiety or fear at the left end, worst possible anxiety or fear at the right end of the scale. | 2 - 90 days after recruiting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative anxiety level of Children VAS-A | Perioperative anxiety level of children measured at T0, T1 and T3 with VAS-A. | 2 - 90 days after recruiting | 
| Perioperative anxiety level of Children VFAS | Perioperative anxiety level of children as measured by the Visual Faces Analog Scale (VFAS) scale at T0, T1, T2 and T3. The VFAS scale consists of six different drawings of faces, supplemented by labels as follows: (Anxiety Level:, none, mild, mild-moderate, moderate, moderate-high, highest) | 2 - 90 days after recruiting | 
| Perioperative anxiety level of accompanying parent | Perioperative anxiety level of accompanying parent measured at T0, T1 and T2 with the VAS-A and VFAS scale | 14 - 110 days after recruiting | 
| Non-disease specific secondary Outcomes | The investigators want to evaluate to which extent the VR program is able to improve the patient and parent's level of preparedness for surgery. Unfortunately, there are currently no validated outcome measures available covering these issues. Therefore, we developed a questionnaire assessing the level of preparedness related to seven aspects of the hospital stay, which are particularly illustrated by the VR program. | 14 - 110 days after recruiting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, Pediatric, Anxiety, Surgery, Anesthesia, Intervention, Exposure, Randomized controlled trial, Pediatric urology, Orthopedic surgery, General Pediatric surgery, Pediatric orthopedics