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

April 28, 2026 updated by: Anna Zubková, National Institute of Mental Health, Czech Republic

The Use of Experiential and Relaxation Virtual Reality to Minimize Anxiety in Children With Life-Limiting Conditions

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Czech Republic
      • Prague, Czech Republic, Czechia, 15006
        • University Hospital Motol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARM 1: relaxation VR followed by experiential VR
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.
Experimental: ARM 2: experiential VR followed by relaxation VR
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention.
Time Frame: Baseline and 15 minutes (post intervention).
Anxiety levels are always measured pre- and post- both VR interventions (relaxation and experiential) using a standardized Czech scale called the "Scale Measuring Anxiety in Children". The scale consists of 17 items, each rated on a 1-4 scale; however, only 15 items are included in the final score. The total score thus ranges from a minimum of 15 to a maximum of 60, with higher scores indicating higher levels of anxiety. The difference between baseline and post-intervention scores is then calculated
Baseline and 15 minutes (post intervention).
Feasibility and Acceptability of the Relaxation App in Pediatric Population.
Time Frame: 3-5 minutes post VR intervention

The relaxation VR app is newly developed and has so far been tested only in adult populations. To measure its feasibility and acceptability, the Simulation Sickness Questionnaire (SSQ), two items from the System Usability Scale (SUS), and several non-standardized questions assessing levels of immersion, enjoyment, engagement, relaxation, and distraction will be used. These scales and items are administered post-intervention.

The SSQ consists of 16 items rated on a 0-3 scale, with a total score range from 0 to 48; higher scores indicate a higher level of simulation sickness. The SUS items use a 1-5 scale (1 = totally agree, 5 = totally disagree), where lower scores reflect better usability. The non-standardized questions also use a 1-5 scale (1 = totally agree, 5 = totally disagree), with lower scores indicating higher levels of immersion, enjoyment, engagement, relaxation, and distraction.
3-5 minutes post VR intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention.
Time Frame: Baseline and 15 minutes (post intervention).
To measure pain levels, the Wong-Baker Faces Pain Rating Scale is used. It is a 1-item scale designed to assess pain among pediatric patients, with scores ranging from 0 to 10. The scale is administered pre- and post-intervention. A higher score indicates a higher level of pain, with 0 representing no pain and 10 representing the most severe pain.
Baseline and 15 minutes (post intervention).
Change in Fear Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention.
Time Frame: Baseline and 15 minutes (post intervention).
To measure fear levels, the Child Fear Scale is employed. It is a 1-item visual scale designed to assess fear associated with medical procedures and hospitalization. The scale ranges from 0 to 4, with higher scores indicating higher levels of fear. It is administered at baseline (pre) and post-intervention, with 0 representing no fear and 4 indicating the highest level of fear.
Baseline and 15 minutes (post intervention).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parents' Opinion on the VR Relaxation and Experiential Interventions for Children/Child Patients.
Time Frame: From enrollement of the child to the end of second session (approximately 4 weeks from enrollement).
Verbal opend-ended question on how the caregivers of the child patient perceive the VR intervention. This outcome is analysed qualitatively.
From enrollement of the child to the end of second session (approximately 4 weeks from enrollement).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Mental Health, Czech Republic

Collaborators

Charles University, Czech Republic
Motol University Hospital

Investigators

  • Study Chair: Iveta Fajnerova, MSc, PhD, National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2024

Primary Completion (Actual)

October 30, 2025

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-670/24
  • 187724 (Other Grant/Funding Number: Charles University Grant Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) will be shared in respect to the outcome measures (baseline and post-treatment), meaning pre-processed data of individuals related to the study's outcome measures. All data will be anonymized, with each participant's data stored under a unique individual code.

IPD Sharing Time Frame

IPD will be shared upon request once the entire project is completed and the study is published in a peer-reviewed impact journal in open-access mode.

IPD Sharing Access Criteria

The IPD can be accessed by anyone upon request to the authors of the study. The authors can be contacted via email, which will be provided in the study publication and on the registration website.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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