CompletedNot Applicable

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

Czechia50 participantsStarted 2024-12-20

Plain-language 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).

Who can participate

Age range

7 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Anxiety Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention.

Timeframe: Baseline and 15 minutes (post intervention).

Feasibility and Acceptability of the Relaxation App in Pediatric Population.

Timeframe: 3-5 minutes post VR intervention

Trial details

NCT IDNCT06915883

SponsorNational Institute of Mental Health, Czech Republic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-30

View on ClinicalTrials.gov More Pediatric Palliative Care trials