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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Virtual Reality
• Intervention / Treatment: Device: Virtual Reality Educational Program

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 Type: Interventional
• Enrollment (Actual): 241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08012
    • Centro Médico Teknon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Will visualize an Educational Virtual Reality video in preoperative period to reduce perioperative anxiety.	Device: Virtual Reality Educational Program; 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.
No Intervention: Usual treatment; Will be applied the usual treatment (provide information on the anaesthetic-surgical process).

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: Servei Central d' Anestesiologia
• Investigators: Principal Investigator: Adriana Carbó García, Nurse, Servicio Central de Anestesiología

Publications and helpful links

General Publications

• Chieng YJ, Chan WC, Klainin-Yobas P, He HG. Perioperative anxiety and postoperative pain in children and adolescents undergoing elective surgical procedures: a quantitative systematic review. J Adv Nurs. 2014 Feb;70(2):243-55. doi: 10.1111/jan.12205. Epub 2013 Jul 19.
• Chow CH, Van Lieshout RJ, Schmidt LA, Dobson KG, Buckley N. Systematic Review: Audiovisual Interventions for Reducing Preoperative Anxiety in Children Undergoing Elective Surgery. J Pediatr Psychol. 2016 Mar;41(2):182-203. doi: 10.1093/jpepsy/jsv094. Epub 2015 Oct 17.
• Liguori S, Stacchini M, Ciofi D, Olivini N, Bisogni S, Festini F. Effectiveness of an App for Reducing Preoperative Anxiety in Children: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):e160533. doi: 10.1001/jamapediatrics.2016.0533. Epub 2016 Aug 1.
• Yip P, Middleton P, Cyna AM, Carlyle AV. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006447. doi: 10.1002/14651858.CD006447.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2019
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): May 2, 2022

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Preanesthetic visit
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: IRV-2017-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No