Effects of Virtual Reality on Perioperative Pediatric Anxiety (VIRTUALPED)

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