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

Thomas More University of Applied Sciences

Status: Unknown

Conditions: Surgery

Treatments: Other: Care as usual; Device: VR 360 video surgery preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT04658030

IC_PED_2

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

VR 360 video surgery preparation

Experimental group

Description:

Preparing pediatric patients for surgery with a newly developed VR 360 degree video. Maximum 30 minutes, one time.

Treatment:

Device: VR 360 video surgery preparation

Care as usual

Active Comparator group

Description:

Preparing the children for surgery with the care as usual. A booklet that can be viewed by the children and parents at home.

Treatment:

Other: Care as usual