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Effects of Virtual Reality on Perioperative Pediatric Anxiety (VIRTUALPED)

G

Germans Trias i Pujol Hospital

Status

Unknown

Conditions

Emergence Delirium
Maladaptive Postoperative Behavior
Preoperative Anxiety

Treatments

Procedure: standard perioperative care without virtual reality program
Device: Virtual Reality glasses

Study type

Interventional

Funder types

Other

Identifiers

NCT04043663
VIRTUALPED

Details and patient eligibility

About

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.

Full description

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.

Enrollment

240 estimated patients

Sex

All

Ages

4 to 12 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

240 participants in 2 patient groups

Virtual reality program group
Experimental group
Description:
Virtual reality program based on a virtual reality guided tour registered in the investigator's pediatric OR setting before surgery.
Treatment:
Device: Virtual Reality glasses
control group
Active Comparator group
Description:
standard perioperative care without virtual reality program
Treatment:
Procedure: standard perioperative care without virtual reality program

Trial contacts and locations

1

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Central trial contact

Teresa Franco, MD

Data sourced from clinicaltrials.gov

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