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Completed

NCT Number: NCT06915883

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

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).

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Key information

Conditions

Pediatric Palliative Care Life Limiting Conditions Life Threatening Diseases

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Motol

Prague, Czech Republic, 15006, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relaxation virtual reality (VR)

Device

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).

Experiential virtual reality (VR)

Device

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health, Czech Republic

Other

Collaborators

  • Charles University, Czech Republic
  • Motol University Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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