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Clinical Trials/NCT04043663
NCT04043663
Unknown
N/A

Effects of Virtual Reality on Perioperative Pediatric Anxiety

Germans Trias i Pujol Hospital1 site in 1 country240 target enrollmentJuly 15, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Preoperative Anxiety
Sponsor
Germans Trias i Pujol Hospital
Enrollment
240
Locations
1
Primary Endpoint
Perioperative Anxiety level
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
July 15, 2019
End Date
July 15, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Teresa Franco

Principal investigator, Medical Doctor

Germans Trias i Pujol Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Perioperative Anxiety level

Time Frame: baseline to 1 day

In children: measured using the modified Yale Perioperative Anxiety Scale, blinded reported by a trained nurse before the patient is transferred to the operating room. Rage from 23.5 up to 100, deemed high anxiety level if test rated over 30

Secondary Outcomes

  • Salivary Cortisol level(baseline to 1 day)

Study Sites (1)

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