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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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VR 360 video surgery preparation

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

Group Type EXPERIMENTAL

VR 360 video surgery preparation

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Care as usual

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes