search
Back to results

Effects of Virtual Reality on Perioperative Pediatric Anxiety (VIRTUALPED)

Primary Purpose

Preoperative Anxiety, Maladaptive Postoperative Behavior, Emergence Delirium

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual Reality glasses
standard perioperative care without virtual reality program
Sponsored by
Germans Trias i Pujol Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preoperative Anxiety focused on measuring virtual reality, pediatric surgery

Eligibility Criteria

4 Years - 12 Years (Child)All SexesAccepts 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

Sites / Locations

  • Teresa FrancoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual reality program group

control group

Arm Description

Virtual reality program based on a virtual reality guided tour registered in the investigator's pediatric OR setting before surgery.

standard perioperative care without virtual reality program

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2019
Last Updated
August 1, 2019
Sponsor
Germans Trias i Pujol Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04043663
Brief Title
Effects of Virtual Reality on Perioperative Pediatric Anxiety
Acronym
VIRTUALPED
Official Title
Effects of Virtual Reality on Perioperative Pediatric Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
July 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Germans Trias i Pujol Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Anxiety, Maladaptive Postoperative Behavior, Emergence Delirium
Keywords
virtual reality, pediatric surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality program group
Arm Type
Experimental
Arm Description
Virtual reality program based on a virtual reality guided tour registered in the investigator's pediatric OR setting before surgery.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
standard perioperative care without virtual reality program
Intervention Type
Device
Intervention Name(s)
Virtual Reality glasses
Intervention Description
Children are encouraged to watch the virtual reality program at least 24 hours before surgery.
Intervention Type
Procedure
Intervention Name(s)
standard perioperative care without virtual reality program
Intervention Description
standard perioperative care without virtual reality program
Primary Outcome Measure Information:
Title
Perioperative Anxiety level
Description
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
Time Frame
baseline to 1 day
Secondary Outcome Measure Information:
Title
Salivary Cortisol level
Description
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
Time Frame
baseline to 1 day
Other Pre-specified Outcome Measures:
Title
Anxiety levels
Description
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
Time Frame
baseline to 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Franco, MD
Phone
+34934978904
Ext
8904
Email
tfranco.germanstrias@gencat.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Franco
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teresa Franco
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Franco, MD
Phone
+34934978904
Ext
8904
Email
tfranco.germanstrias@gencat.cat
First Name & Middle Initial & Last Name & Degree
Alicia Melero, MD
First Name & Middle Initial & Last Name & Degree
Frederic Ródenas, MD
First Name & Middle Initial & Last Name & Degree
Sandra Clemente, MD
First Name & Middle Initial & Last Name & Degree
Eva Tres, RN
First Name & Middle Initial & Last Name & Degree
Marisa Janeiro, RN

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Virtual Reality on Perioperative Pediatric Anxiety

We'll reach out to this number within 24 hrs