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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03578393
• Other study ID #: IRV-2017-01
• Status: Completed
• Phase: N/A
• Start date: February 2, 2019
• Est. completion date: May 2, 2022

Study information

• Verified date: May 2022
• Source: Servei Central d' Anestesiologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: May 2, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Virtual Reality

Intervention

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.

Locations

Country	Name	City	State
Spain	Centro Medico Teknon	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Servei Central d' Anestesiologia

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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 — View Citation

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 — View Citation

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 — View Citation

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. Review. Update in: Cochrane Databa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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
Secondary	Parental satisfaction	Numeric Scale indicate 0= unsatisfied and 10= totally satisfied.	1 day. At hospital discharge (24 hours after surgery).
Secondary	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.
Secondary	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.
Secondary	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).