Clinical trial NCT03578393: Efficacy of a Preoperative Virtual Reality Intervention as a Paediatric Anxiety Improvement Strategy
Official title: Efficacy of a Preoperative Virtual Reality Intervention as a Paediatric Anxiety Improvement Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Virtual Reality
Keywords: Preanesthetic visit
Lead sponsor: Servei Central d'Anestesiologia
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 241
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Preoperative Change of Paediatric Anxiety level
timeFrame: 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 outcomes:
measure: Paediatric pain
timeFrame: 2 days. The surgery day and the postoperative day (24 hours after surgery).
measure: Modified Aldrete postanesthetic recuperation
timeFrame: 1 day. The surgery day
measure: Parental satisfaction
timeFrame: 1 day. At hospital discharge (24 hours after surgery).
measure: Resources
timeFrame: 1 day. The surgery day.
measure: Children's collaboration during anaesthesia induction.
timeFrame: 1 day. The surgery day, during anaesthesia induction.
measure: Paediatric Delirium
timeFrame: 2 days. The surgery day and the postoperative day (24 hours after surgery).
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centro Medico Teknon
Study officials:
affiliation: Servicio Central de Anestesiología
name: Adriana Carbó García, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 2015 Oct 17.
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 Aug 1.
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.