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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04658030
• Other study ID #: IC_PED_2
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2021
• Source: Thomas More University of Applied Sciences
• Contact: Wessel van de Veerdonk, PhD
• Phone: (0)485 15 60 36
• Email: wessel.vandeveerdonk[@]thomasmore.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Surgery

Intervention

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.

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.

Locations

Country	Name	City	State
Belgium	Heilig Hart Ziekenhuis Lier	Lier	Vlaanderen

Sponsors (3)

Lead Sponsor	Collaborator
Thomas More University of Applied Sciences	Fotosfeer, Heilig Hart Ziekenhuis Lier

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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.
Primary	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
Primary	Intervention adherence	Measure intervention adherence by registering the number of fully completed sessions.	Immediately after the intervention
Primary	Procedure time	The procedure time of intervention in minutes	Immediately after the intervention
Secondary	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