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Completed

NCT Number: NCT03578393

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Virtual Reality

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Medico Teknon

Barcelona, 08012, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality Educational Program

Device

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 outcomes

  1. 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 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 outcomes

  1. Paediatric pain

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

    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. Modified Aldrete postanesthetic recuperation

    Time frame: 1 day. The surgery day

    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.

  3. Parental satisfaction

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

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

  4. Resources

    Time frame: 1 day. The surgery day.

    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)

  5. Children's collaboration during anaesthesia induction.

    Time frame: 1 day. The surgery day, 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.

  6. Paediatric Delirium

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

    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.

Sponsors and collaborators

Lead sponsor

Servei Central d'Anestesiologia

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 6, 2018
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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