Effects of Virtual Reality on Perioperative Pediatric Anxiety (VIRTUALPED)

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.

Study Overview

• Status: Unknown
• Conditions: Emergence Delirium; Preoperative Anxiety; Maladaptive Postoperative Behavior
• Intervention / Treatment: Device: Virtual Reality glasses; Procedure: standard perioperative care without virtual reality 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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • Teresa Franco
      • Contact: Teresa Franco, MD; Phone Number: 8904 +34934978904; Email: tfranco.germanstrias@gencat.cat
      • Sub-Investigator: Alicia Melero, MD
      • Sub-Investigator: Frederic Ródenas, MD
      • Sub-Investigator: Sandra Clemente, MD
      • Sub-Investigator: Eva Tres, RN
      • Sub-Investigator: Marisa Janeiro, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality program group; Virtual reality program based on a virtual reality guided tour registered in the investigator's pediatric OR setting before surgery.	Device: Virtual Reality glasses; Children are encouraged to watch the virtual reality program at least 24 hours before surgery.
Active Comparator: control group; standard perioperative care without virtual reality program	Procedure: standard perioperative care without virtual reality program; standard perioperative care without virtual reality program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Germans Trias i Pujol Hospital
• Investigators: Principal Investigator: Teresa Franco, Germans Trias i Pujol Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): July 15, 2021

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: virtual reality; pediatric surgery
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Anxiety Disorders; Emergence Delirium
• Other Study ID Numbers: VIRTUALPED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No