Effects of Virtual Reality on Perioperative Pediatric Anxiety

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2021-07-15

Brief Summary

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This study evaluates the effect of virtual reality on anxiety levels in a pediatric surgical population. Half of participants will receive standard perioperative treatment, while the other half will receive additionally a virtual reality local program.

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Detailed Description

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It is well known that there is a high incidence of significant anxiety in pediatric population perioperatively, with adverse side effects in terms of emergence delirium and maladaptive postoperative behaviors. Many different strategies have been designed in order to minimize these negative consequences.

Virtual reality is a new and simple technology that can be used at young ages. The aim of this study is to measure anxiety levels at different times in children scheduled for ambulatory surgery compared to patients with standard care without virtual reality.

Conditions

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Preoperative Anxiety Maladaptive Postoperative Behavior Emergence Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Virtual reality program group

Virtual reality program based on a virtual reality guided tour registered in the investigator's pediatric OR setting before surgery.

Group Type EXPERIMENTAL

Virtual Reality glasses

Intervention Type DEVICE

Children are encouraged to watch the virtual reality program at least 24 hours before surgery.

control group

standard perioperative care without virtual reality program

Group Type ACTIVE_COMPARATOR

standard perioperative care without virtual reality program

Intervention Type PROCEDURE

standard perioperative care without virtual reality program

Interventions

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Virtual Reality glasses

Children are encouraged to watch the virtual reality program at least 24 hours before surgery.

Intervention Type DEVICE

standard perioperative care without virtual reality program

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Child between 4 and 12 years old
* Elective ambulatory surgery
* Parents posses a smart phone
* Child and parents understand Spanish or Catalan
* Patient information has been explained
* Informed Consent is signed
* Surgery scheduled in the morning

Exclusion Criteria

* Child has hearing impairment
* Child has visual impairment
* Child has previous experience of anesthesia
* American Society os Anesthesiologists (ASA) score of III or greater
* Children with history of seizures
* Children under psychiatric treatment

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes