Clinical trial NCT06915883: Experiential and Relaxation Virtual Reality as a Tool for Easing Anxiety in Seriously Ill Children
Official title: The Use of Experiential and Relaxation Virtual Reality to Minimize Anxiety in Children With Life-Limiting Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Palliative Care
Life Limiting Conditions
Life Threatening Diseases
Keywords: experiential VR
relaxation VR
modern technologies in supportive care in medicine
pediatric palliative care
virtual reality
anxiety reduction
pediatric
Lead sponsor: National Institute of Mental Health, Czech Republic
Sponsor class: OTHER
Collaborators: name: Motol University Hospital
name: Charles University, Czech Republic
First posted: 2025-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two virtual reality interventions (experiential and relaxation) are provided to subjects at different time periods, the sequence of treatments is randomized for each subject.
Primary purpose: SUPPORTIVE_CARE

Brief 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).


Eligibility criteria: Inclusion Criteria:

* age 7-17.9 years
* sufficient level of contact with the environment and ability to cooperate
* children and parents fluent in Czech
* diagnosis of a life-threatening or life-limiting disease according to the internationally accepted list of palliatively relevant diagnoses
* pediatric patients treated at the University Hospital Motol

Exclusion Criteria:

* age below 7 or above 17.9 years
* unstable health status
* inability to speak Czech
* absence of parental consent for participation in the study

Primary outcomes:
measure: Change in Anxiety Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention.
timeFrame: Baseline and 15 minutes (post intervention).
measure: Feasibility and Acceptability of the Relaxation App in Pediatric Population.
timeFrame: 3-5 minutes post VR intervention
Secondary outcomes:
measure: Change in Pain Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention.
timeFrame: Baseline and 15 minutes (post intervention).
measure: Change in Fear Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention.
timeFrame: Baseline and 15 minutes (post intervention).
Other outcomes:
measure: Parents' Opinion on the VR Relaxation and Experiential Interventions for Children/Child Patients.
timeFrame: From enrollement of the child to the end of second session (approximately 4 weeks from enrollement).
Locations:
city: Prague
country: Czechia
facility: University Hospital Motol
state: Czech republic
Study officials:
affiliation: National Institute of Mental Health (NIMH)
name: Iveta Fajnerova, MSc, PhD
role: STUDY_CHAIR
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