Experiential and Relaxation Virtual Reality as a Tool for Easing Anxiety in Seriously Ill Children

Summary

The goal of this clinical trial is to assess the use of experiential and relaxation virtual reality (VR) interventions in easing anxiety and other distress symptoms in children with life-limiting and/or life-threatening conditions (LLC/LTC). The main questions it aims to answer are:

1. Does experiential and relaxation VR help to decrease anxiety in severely ill children?
2. What effect does it have on pain and fear?
3. Is there a difference between experiential and relaxation VR in the observed outcome measures?
4. How is the newly developed relaxation VR app BreezeTerraVR perceived by children with LLC/LTC?
5. How do caregivers of the patients perceive VR as an intervention tool for psychological distress? Researchers will compare baseline levels of outcome measures (e.g. anxiety) to post-intervention levels to determine if there is an effect.

Participants will:

* Experience both types of VR interventions-experiential and relaxation VR-for 7 to 15 minutes in two sessions (the number of days between sessions will depend on each child's medical plan), the order of interventions is randomized.
* Fill out a set of short questionnaires before and after each intervention (approximately 5 minutes per phase).

Conditions

• Pediatric Palliative Care
• Life Limiting Conditions
• Life Threatening Diseases

Interventions

DEVICE

Relaxation virtual reality (VR)

A newly developed self-guided app BreezeTrerraVR that helps patients practice relaxation breathing in an immersive virtual environment, using voice prompts, visual cues, and respiratory biofeedback for guidance. The app was developed in the VR center at the National Institute of Mental Health, Czech Republic (supported by THE JOHANNES AMOS COMENIUS PROGRAMME (OP JAC) EXCELLENCE IN RESEARCH, Title: Research of Excellence on Digital Technologies and Wellbeing, Project Registration Number: CZ. 02.01.01/00/22\_008/0004583).

DEVICE

Experiential virtual reality (VR)

The experiential VR intervention will use the VR program "Ocean Rift" (an experience of the underwater world and its animals). It is a calm experiential and distraction game program that does not require much mobility and interaction and is therefore suitable for pediatric patients and hospital environments. This VR application is also used in available published research.

Sponsors & Collaborators

• Motol University Hospital

  collaborator OTHER

• Charles University, Czech Republic

  collaborator OTHER

• National Institute of Mental Health, Czech Republic

  lead OTHER

Principal Investigators

• Iveta Fajnerova, MSc, PhD · National Institute of Mental Health (NIMH)

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

7 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-20

Primary Completion

2025-10-30

Completion

2025-10-31

Countries

• Czechia

Study Locations