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

Not Applicable

Completed

• Conditions: Virtual Reality; Anxiety
• Interventions: Device: Virtual Reality Educational Program

• Registration Number: NCT03578393
• Lead Sponsor: Servei Central d' Anestesiologia

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-06
• Study Start: 2019-02-02
• Primary Completion: 2022-04-15
• Status Verified: 2022-05
• Study Completion: 2022-05-02
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Virtual Reality Educational Program	Will visualize an Educational Virtual Reality video in preoperative period to reduce perioperative anxiety.

Primary Outcome Measures

Name	Time	Method
Preoperative Change of Paediatric Anxiety level	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.	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.

Secondary Outcome Measures

Name	Time	Method
Modified Aldrete postanesthetic recuperation	1 day. The surgery day	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.
Paediatric pain	2 days. The surgery day and the postoperative day (24 hours after surgery).	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.
Paediatric Delirium	2 days. The surgery day and the postoperative day (24 hours after surgery).	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.
Parental satisfaction	1 day. At hospital discharge (24 hours after surgery).	Numeric Scale indicate 0= unsatisfied and 10= totally satisfied.
Children's collaboration during anaesthesia induction.	1 day. The surgery day, 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.
Resources	1 day. The surgery day.	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)

Trial Locations

Locations (1)

Centro Medico Teknon; 🇪🇸 Barcelona, Spain