Clinical trial NCT04658030: Immersive Care - Virtual Reality(VR) 360 Pediatric Surgery Preparation.
Official title: 360° Video VR Surgery Preparation: Feasibility, Acceptability, Tolerability and Initial Effectiveness of Virtual Reality for Children in a Flemish Hospital.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery
Keywords: Pediatrics
Preparation
Virtual Reality
360 Video
Anxiety
Lead sponsor: Thomas More University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Heilig Hart Ziekenhuis Lier
name: Fotosfeer
First posted: 2020-12-08
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change from baseline in staff attitude towards the intervention
timeFrame: Staff: Measurement takes place in week 5 after the start of the study.
measure: Change from baseline in tolerability (Do participants experience symptoms of simulator sickness?)
timeFrame: Immediately after the intervention
measure: Usability of the intervention: System Usability Scale (SUS)
timeFrame: Immediately after the intervention.
measure: Patient satisfaction: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Immediately after the intervention
measure: Intervention adherence
timeFrame: Immediately after the intervention
measure: Procedure time
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Preliminary effectiveness (change in anxiety between timepoints) (Intervention and control)
timeFrame: 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
Other outcomes:
Locations:
city: Lier
country: Belgium
facility: Heilig Hart Ziekenhuis Lier
state: Vlaanderen
Study officials:
affiliation: Thomas More University of Applied Sciences
name: Wessel van de Veerdonk, PhD
role: PRINCIPAL_INVESTIGATOR
References: