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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-02

Study Completion Date

2022-05-02

Brief Summary

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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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Detailed Description

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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.

Conditions

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Anxiety Virtual Reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Virtual Reality Educational Program

Intervention Type 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.

Usual treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes