Effects of Virtual Reality on Perioperative Pediatric Anxiety

Emergence Delirium Clinical Trial

— VIRTUALPED  

Official title:

Effects of Virtual Reality on Perioperative Pediatric Anxiety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04043663
• Other study ID #: VIRTUALPED
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: July 15, 2021

Study information

• Verified date: August 2019
• Source: Germans Trias i Pujol Hospital
• Contact: Teresa Franco, MD
• Phone: +34934978904
• Email: tfranco.germanstrias[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: July 15, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Delirium
• Emergence Delirium
• Maladaptive Postoperative Behavior
• Preoperative Anxiety

Intervention

Device:
• Virtual Reality glasses
Children are encouraged to watch the virtual reality program at least 24 hours before surgery.

Procedure:
• standard perioperative care without virtual reality program
standard perioperative care without virtual reality program

Locations

Country	Name	City	State
Spain	Teresa Franco	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety levels	In parents: State Anxiety Inventory Scale, self questionnaire made of 20 questions rated from 0 to 3 at the holding area. Range from 1 up to 10	baseline to 1 day
Primary	Perioperative Anxiety level	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	baseline to 1 day
Secondary	Salivary Cortisol level	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	baseline to 1 day