Immersive Care - Virtual Reality(VR) 360 Pediatric Surgery Preparation.

360° Video VR Surgery Preparation: Feasibility, Acceptability, Tolerability and Initial Effectiveness of Virtual Reality for Children in a Flemish Hospital.

Context: This study is part of the larger Immersive Care project which (in short) seeks the connection between technology and care by conducting feasibility studies with promising technological interventions tailored to care.

This is one of the case studies from the larger project titled: 360 ° video VR surgery preparation: feasibility, acceptability, tolerability and initial effectiveness of virtual reality for children in a Flemish hospital.

Domain: This scientific study will take place in 1 hospital on the pediatric ward. The target group consists of children between 6 and 12 years of age who will undergo an operation, the parents and the care providers involved.

Target:

1. Assess the acceptability, feasibility and tolerability of the 360 ° video VR surgery preparation.

2. Assess the effectiveness of the 360 ° video VR surgery preparation on preoperative procedural anxiety in children, comparing the intervention with care as usual (CAU *).

   • CAU in this study is a picture book which is a kind of animated video with text to explain what will happen on the day of the operation.

Study Overview

• Status: Recruiting
• Conditions: Surgery
• Intervention / Treatment: Device: VR 360 video surgery preparation; Other: Care as usual

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wessel van de Veerdonk, PhD; Phone Number: +32 (0)485 15 60 36; Email: wessel.vandeveerdonk@thomasmore.be
• Study Contact Backup: Name: Sylvie Bernaerts, PhD; Phone Number: +32 (0)34 32 40 50; Email: sylvie.bernaerts@thomasmore.be

Study Locations

• Belgium
  • Vlaanderen
    • Lier, Vlaanderen, Belgium, 2500
      • Recruiting
      • Heilig Hart ziekenhuis Lier
      • Contact: Marieke Deschacht; Phone Number: +32 3 491 23 63; Email: Marieke.Deschacht@heilighartlier.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent must be obtained
• Inpatient or outpatient in the study site (Heilig Hart Hospital Lier): each paediatric patient who will undergo surgery during the study period (01-12-2020 and 30-09- 2021).
• Age range of ≥ 6 and ≤ 12
• Normal or corrected-to-normal vision
• Normal or corrected-to-normal hearing

Exclusion Criteria:

• Patient has a history of seizure disorders (e.g. epilepsy)
• Physical impairment that preclude VR intervention (e.g. facial burns or wounds, contagious infectious disease, need for intensive care)
• Non-Dutch/English/French speaker: Both the paediatric patient and his/her caregiver must be able to provide informed consent and assent
• Previous enrolment in this study (during a previous hospital stay)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VR 360 video surgery preparation; Preparing pediatric patients for surgery with a newly developed VR 360 degree video. Maximum 30 minutes, one time.	Device: VR 360 video surgery preparation; Preparing children on the surgery by a virtual reality 360 degrees video tour from the pediatric ward to the surgery room. In this video all information is given necessary for the surgery. This takes a maximum of 30 minutes and will be performed 1 time.
ACTIVE_COMPARATOR: Care as usual; Preparing the children for surgery with the care as usual. A booklet that can be viewed by the children and parents at home.	Other: Care as usual; Preparing the children for surgery with the care as usual. A booklet that can be viewed by the children and parents at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in staff attitude towards the intervention	Unified theory of acceptance and use of technology tests the acceptance of the staff towards the intervention in this study. Assess change in patient attitude towards the intervention with the Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire survey. The UTAUT questionnaire survey for end-users consists of 20 items with five response options ranging from "Totally disagree" to "Totally agree". The questionnaire survey consists of 7 subscales, for most of which higher scores indicate a more positive attitude towards the intervention.	Staff: Measurement takes place in week 5 after the start of the study.
Change from baseline in tolerability (Do participants experience symptoms of simulator sickness?)	Assessment of physical side effects after exposure to VR by the Pediatric Simulator Sickness Questionnaire (Peds SSQ). The Peds SSQ contains queries that probe 4 symptom categories: (1) eye strain (queries 1-4); (2) head and neck discomfort (queries 5 and 6); (3) sleepiness (solipsism) or fatigue (queries 7 and 8); and dizziness or nausea (visually induced motion sickness, queries 9-13). The scale that is used is a likert scale (with additional faces) ranging from 0 to 6 per query (0 = no of the above "complaints"; 6 = a lot of the above "complaints".	Immediately after the intervention
Usability of the intervention: System Usability Scale (SUS)	Assessment of ease of use of the intervention with the System Usability Scale (SUS). The SUS is a 10 item questionnaire with five response options for respondents; from "strongly disagree" to "strongly agree". A higher SUS score indicates better usability.	Immediately after the intervention.
Patient satisfaction: Client Satisfaction Questionnaire (CSQ-8)	Assessment of client satisfaction with the VR application with the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 consists of 8 items with four response options. Higher scores indicate higher satisfaction.	Immediately after the intervention
Intervention adherence	Measure intervention adherence by registering the number of fully completed sessions.	Immediately after the intervention
Procedure time	The procedure time of intervention in minutes	Immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary effectiveness (change in anxiety between timepoints) (Intervention and control)	Measuring procedural anxiety (with a Visual Analogue Scale) (1.Before intervention/control, 2. just after intervention/control and 3.just before surgery)	Measurement 1: Immediately after signing the informed consent, day 1 of study. Measurement 2: Immediately after the intervention, day 1 of study. Measurement 3: Just before surgery, day 4 of study

Collaborators and Investigators

• Sponsor: Thomas More University of Applied Sciences
• Collaborators: Heilig Hart Ziekenhuis Lier; Fotosfeer
• Investigators: Principal Investigator: Wessel van de Veerdonk, PhD, Thomas More University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ANTICIPATED): September 30, 2021
• Study Completion (ANTICIPATED): September 30, 2021

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (ACTUAL): December 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Anxiety; Pediatrics; Virtual Reality; Preparation; 360 Video
• Other Study ID Numbers: IC_PED_2

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