Effects of Virtual Reality on Perioperative Pediatric Anxiety

Not Applicable

• Conditions: Preoperative Anxiety; Maladaptive Postoperative Behavior; Emergence Delirium
• Interventions: Device: Virtual Reality glasses; Procedure: standard perioperative care without virtual reality program

• Registration Number: NCT04043663
• Lead Sponsor: Germans Trias i Pujol Hospital

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.

Study Timeline

• Study Start: 2019-07-15
• Study First Submitted: 2019-07-25
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-01
• Last Update Submitted: 2019-08-01
• Study First Posted: 2019-08-02
• Last Update Posted: 2019-08-05
• Primary Completion: 2020-12-31
• Study Completion: 2021-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality program group	Virtual Reality glasses	Virtual reality program based on a virtual reality guided tour registered in the investigator's pediatric OR setting before surgery.
control group	standard perioperative care without virtual reality program	standard perioperative care without virtual reality program

Primary Outcome Measures

Name	Time	Method
Perioperative Anxiety level	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 Outcome Measures

Name	Time	Method
Salivary Cortisol level	baseline to 1 day	In children: Saliva sample collection using Salivette system before the patient is transferred to the operating room. Levels over 8nmol/l can be caused by high anxiety level

Trial Locations

Locations (1)

Teresa Franco; 🇪🇸 Badalona, Barcelona, Spain