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

Primary Purpose

Anxiety, Virtual Reality

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual Reality Educational Program
Sponsored by
Servei Central d' Anestesiologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring Preanesthetic visit

Eligibility Criteria

3 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centro Medico Teknon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual treatment

Arm Description

Will visualize an Educational Virtual Reality video in preoperative period to reduce perioperative anxiety.

Will be applied the usual treatment (provide information on the anaesthetic-surgical process).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Parental satisfaction
Numeric Scale indicate 0= unsatisfied and 10= totally satisfied.
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)
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.
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.

Full Information

First Posted
May 30, 2018
Last Updated
May 19, 2022
Sponsor
Servei Central d' Anestesiologia
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1. Study Identification

Unique Protocol Identification Number
NCT03578393
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 2, 2019 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
May 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Servei Central d' Anestesiologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Virtual Reality
Keywords
Preanesthetic visit

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Will visualize an Educational Virtual Reality video in preoperative period to reduce perioperative anxiety.
Arm Title
Usual treatment
Arm Type
No Intervention
Arm Description
Will be applied the usual treatment (provide information on the anaesthetic-surgical process).
Intervention Type
Device
Intervention Name(s)
Virtual Reality Educational Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preoperative Change of Paediatric Anxiety level
Description
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.
Time Frame
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 Measure Information:
Title
Paediatric pain
Description
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.
Time Frame
2 days. The surgery day and the postoperative day (24 hours after surgery).
Title
Modified Aldrete postanesthetic recuperation
Description
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.
Time Frame
1 day. The surgery day
Title
Parental satisfaction
Description
Numeric Scale indicate 0= unsatisfied and 10= totally satisfied.
Time Frame
1 day. At hospital discharge (24 hours after surgery).
Title
Resources
Description
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)
Time Frame
1 day. The surgery day.
Title
Children's collaboration during anaesthesia induction.
Description
It will be measured by Induction Compliance Checklist (ICC). ICC score range is 0 to 10, 0 means collaborate and 10 no collaborate.
Time Frame
1 day. The surgery day, during anaesthesia induction.
Title
Paediatric Delirium
Description
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.
Time Frame
2 days. The surgery day and the postoperative day (24 hours after surgery).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Carbó García, Nurse
Organizational Affiliation
Servicio Central de Anestesiología
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Medico Teknon
City
Barcelona
ZIP/Postal Code
08012
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23865442
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.
Results Reference
result
PubMed Identifier
26476281
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.
Results Reference
result
PubMed Identifier
27294708
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.
Results Reference
result
PubMed Identifier
19588390
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.
Results Reference
result

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

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