Efficacy of a Preoperative Virtual Reality Intervention as a Paediatric Anxiety Improvement Strategy
1 other identifier
interventional
241
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable anxiety
Started Feb 2019
Longer than P75 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2018
CompletedFirst Posted
Study publicly available on registry
July 6, 2018
CompletedStudy Start
First participant enrolled
February 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2022
CompletedMay 23, 2022
May 1, 2022
3.2 years
May 30, 2018
May 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Paediatric pain
2 days. The surgery day and the postoperative day (24 hours after surgery).
Modified Aldrete postanesthetic recuperation
1 day. The surgery day
Parental satisfaction
1 day. At hospital discharge (24 hours after surgery).
Resources
1 day. The surgery day.
Children's collaboration during anaesthesia induction.
1 day. The surgery day, during anaesthesia induction.
- +1 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALWill visualize an Educational Virtual Reality video in preoperative period to reduce perioperative anxiety.
Usual treatment
NO INTERVENTIONWill be applied the usual treatment (provide information on the anaesthetic-surgical process).
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Medico Teknon
Barcelona, 08012, Spain
Related Publications (5)
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.
PMID: 23865442RESULTChow 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.
PMID: 26476281RESULTLiguori 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.
PMID: 27294708RESULTYip 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.
PMID: 19588390RESULTCarbo A, Tresandi D, Tril C, Fernandez-Rodriguez D, Carrero E. Usefulness of a virtual reality educational program for reducing preoperative anxiety in children: A randomised, single-centre clinical trial. Eur J Anaesthesiol. 2024 Sep 1;41(9):657-667. doi: 10.1097/EJA.0000000000002032. Epub 2024 Jun 24.
PMID: 38916221DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adriana Carbó García, Nurse
Servicio Central de Anestesiología
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nurse
Study Record Dates
First Submitted
May 30, 2018
First Posted
July 6, 2018
Study Start
February 2, 2019
Primary Completion
April 15, 2022
Study Completion
May 2, 2022
Last Updated
May 23, 2022
Record last verified: 2022-05