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AnxietyNCT03578393

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

A study testing Virtual Reality Educational Program in people with Anxiety and Virtual Reality, run by Servei Central d'Anestesiologia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 3 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Anxiety, Virtual Reality
What is being tested?
Virtual Reality Educational Program
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
1 siteSpain
Study dates
2 Feb 2019to 2 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Centro Medico Teknon

    Barcelona, 08012

Other trials in Spain

About this study

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.

Read the 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.

Being tested
Virtual Reality Educational Program
Keywords
Preanesthetic visit
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality Educational ProgramDevice

    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.

Study groups in NCT03578393
Study groupRoleWhat they receive
InterventionExperimentalWill visualize an Educational Virtual Reality video in preoperative period to reduce perioperative anxiety.
Receives: Device: Virtual Reality Educational Program
Usual treatmentNo interventionWill be applied the usual treatment (provide information on the anaesthetic-surgical process).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

    Measured: 2 days. The surgery day and the postoperative day (24 hours after surgery).

  2. 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.

    Measured: 1 day. The surgery day

  3. Parental satisfaction

    Numeric Scale indicate 0= unsatisfied and 10= totally satisfied.

    Measured: 1 day. At hospital discharge (24 hours after surgery).

  4. 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)

    Measured: 1 day. The surgery day.

  5. 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.

    Measured: 1 day. The surgery day, during anaesthesia induction.

  6. 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.

    Measured: 2 days. The surgery day and the postoperative day (24 hours after surgery).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2018
  2. Study start2 Feb 2019
  3. Primary completion15 Apr 2022
  4. Study completion2 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03578393
Sponsor's protocol ID
IRV-2017-01
Status last verified
May 2022
First submitted
30 May 2018
Last updated
23 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 23865442

  • 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.

    PubMed 26476281

  • 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.

    PubMed 27294708

  • 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.

    PubMed 19588390

  • Carbo 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.

    PubMed 38916221

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Educational Program in people with Anxiety and Virtual Reality, run by Servei Central d'Anestesiologia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preoperative Change of Paediatric Anxiety level (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03578393, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.

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