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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03578393
Enrollment
241
Registered
2018-07-06
Start date
2019-02-02
Completion date
2022-05-02
Last updated
2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Virtual Reality

Keywords

Preanesthetic visit

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.

Interventions

DEVICEVirtual 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.

Sponsors

Servei Central d'Anestesiologia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 12 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Preoperative Change of Paediatric Anxiety level3 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

MeasureTime frameDescription
Modified Aldrete postanesthetic recuperation1 day. The surgery dayIt 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 satisfaction1 day. At hospital discharge (24 hours after surgery).Numeric Scale indicate 0= unsatisfied and 10= totally satisfied.
Paediatric pain2 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.
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.
Paediatric Delirium2 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.
Resources1 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)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026