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

Sponsor
Servei Central d' Anestesiologia (Other)
Overall Status
Completed
CT.gov ID
NCT03578393
Collaborator
(none)
241
1
2
38.9
6.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality Educational Program
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
241 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Efficacy of a Preoperative Virtual Reality Intervention as a Paediatric Anxiety Improvement Strategy
Actual Study Start Date :
Feb 2, 2019
Actual Primary Completion Date :
Apr 15, 2022
Actual Study Completion Date :
May 2, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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

Device: Virtual Reality Educational Program
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.

No Intervention: Usual treatment

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

Outcome Measures

Primary Outcome Measures

  1. Preoperative Change of Paediatric Anxiety level [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 Outcome Measures

  1. Paediatric pain [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 [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 [1 day. At hospital discharge (24 hours after surgery).]

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

  4. Resources [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. [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centro Medico Teknon Barcelona Spain 08012

Sponsors and Collaborators

  • Servei Central d' Anestesiologia

Investigators

  • Principal Investigator: Adriana Carbó García, Nurse, Servicio Central de Anestesiología

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adriana Carbó García, Nurse, Servei Central d' Anestesiologia
ClinicalTrials.gov Identifier:
NCT03578393
Other Study ID Numbers:
  • IRV-2017-01
First Posted:
Jul 6, 2018
Last Update Posted:
May 23, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Adriana Carbó García, Nurse, Servei Central d' Anestesiologia
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 23, 2022