Pediatric Palliative CareNCT06915883
Experiential and Relaxation Virtual Reality as a Tool for Easing Anxiety in Seriously Ill Children
A study testing Relaxation virtual reality (VR) and Experiential virtual reality (VR) in people with Pediatric Palliative Care and Life Limiting Conditions, run by National Institute of Mental Health, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Pediatric Palliative Care, Life Limiting Conditions, Life Threatening Diseases
- What is being tested?
- Relaxation virtual reality (VR) and Experiential virtual reality (VR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Dec 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- age below 7 or above 17.9 years
- unstable health status
- inability to speak Czech
- absence of parental consent for participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- Does experiential and relaxation VR help to decrease anxiety in severely ill children?
- What effect does it have on pain and fear?
- Is there a difference between experiential and relaxation VR in the observed outcome measures?
- How is the newly developed relaxation VR app BreezeTerraVR perceived by children with LLC/LTC?
- 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.
Read more
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).
- Being tested
- Relaxation virtual reality (VR), Experiential virtual reality (VR)
- Keywords
- experiential VR, relaxation VR, modern technologies in supportive care in medicine, pediatric palliative care, virtual reality, anxiety reduction, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1: relaxation VR followed by experiential VR | Experimental | Not described Receives: Device: Relaxation virtual reality (VR); Device: Experiential virtual reality (VR) |
| ARM 2: experiential VR followed by relaxation VR | Experimental | Not described Receives: Device: Relaxation virtual reality (VR); Device: Experiential virtual reality (VR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Levels from Baseline following Experiential and Relaxation Virtual Reality 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
Measured: Baseline and 15 minutes (post intervention).
Feasibility and Acceptability of the Relaxation App in Pediatric Population.
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.
Measured: 3-5 minutes post VR intervention
Secondary outcomes (2)
Change in Pain Levels from Baseline following Experiential and Relaxation Virtual Reality 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.
Measured: Baseline and 15 minutes (post intervention).
Change in Fear Levels from Baseline following Experiential and Relaxation Virtual Reality 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.
Measured: Baseline and 15 minutes (post intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start20 Dec 2024
- Primary completion30 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pediatric Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Motol University Hospital, Charles University, Czech Republic
- Responsible party
- Principal investigator, Anna Zubková, Charles University, Czech Republic
- Investigators
- Iveta Fajnerova, MSc, PhD, Study chair, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915883
- Sponsor's protocol ID
- EK-670/24
- Other IDs
- 187724
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Toman J. Škály na měření úzkosti a úzkostlivosti u dětí. Praha: Národní ústav pro vzdělávání; 2018.
McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
PubMed 21806301Kennedy R, Lane N, Berbaum K, Lilienthal M. Simulator Sickness Questionnaire: An enhanced method for quantifying simulator sickness. Int J Aviat Psychol. 1993;3(3):203-20.
Gerceker GO, Bektas M, Aydinok Y, Oren H, Ellidokuz H, Olgun N. The effect of virtual reality on pain, fear, and anxiety during access of a port with huber needle in pediatric hematology-oncology patients: Randomized controlled trial. Eur J Oncol Nurs. 2021 Feb;50:101886. doi: 10.1016/j.ejon.2020.101886. Epub 2020 Dec 1.
PubMed 33321461Fraser LK, Gibson-Smith D, Jarvis S, Norman P, Parslow R. 'Make Every Child Count' Estimating current and future prevalence of children and young people with life-limiting conditions in the United Kingdom FINAL REPORT FEBRUARY 2020. 2020;(February):1-61
Foundation WBF. Wong-Baker FACES® Pain Rating Scale. 2016.
Caruso TJ, George A, Menendez M, De Souza E, Khoury M, Kist MN, Rodriguez ST. Virtual reality during pediatric vascular access: A pragmatic, prospective randomized, controlled trial. Paediatr Anaesth. 2020 Feb;30(2):116-123. doi: 10.1111/pan.13778. Epub 2019 Dec 19.
PubMed 31785015
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Experiential and Relaxation Virtual Reality to Minimize Anxiety in Children With Life-Limiting Conditions
- ClinicalTrials.gov ID
- NCT06915883
- Acronym / sponsor ID
- EK-670/24
- Keywords
- experiential VR, relaxation VR, modern technologies in supportive care in medicine, pediatric palliative care, virtual reality, anxiety reduction, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Institute of Mental Health, Czech RepublicUniversity, hospital or other
- Collaborators
- Motol University Hospital, Charles University, Czech Republic
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does experiential and relaxation VR help to decrease anxiety in severely ill children?
- What effect does it have on pain and fear?
- Is there a difference between experiential and relaxation VR in the observed outcome measures?
- How is the newly developed relaxation VR app BreezeTerraVR perceived by children with LLC/LTC?
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ARM 1: relaxation VR followed by experiential VR | Experimental | Device: Relaxation virtual reality (VR), Device: Experiential virtual reality (VR) |
| ARM 2: experiential VR followed by relaxation VR | Experimental | Device: Relaxation virtual reality (VR), Device: Experiential virtual reality (VR) |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- age below 7 or above 17.9 years
- unstable health status
- inability to speak Czech
- absence of parental consent for participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | ARM 1: relaxation VR followed by experiential VR, ARM 2: experiential VR followed by relaxation VR |
| 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. | Device | ARM 1: relaxation VR followed by experiential VR, ARM 2: experiential VR followed by relaxation VR |
Primary outcome
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
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.
2 secondary outcomes
Change in Pain Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention.
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- BackgroundToman J. Škály na měření úzkosti a úzkostlivosti u dětí. Praha: Národní ústav pro vzdělávání; 2018.
- Background: PubMed 21806301McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
- BackgroundKennedy R, Lane N, Berbaum K, Lilienthal M. Simulator Sickness Questionnaire: An enhanced method for quantifying simulator sickness. Int J Aviat Psychol. 1993;3(3):203-20.
- Background: PubMed 33321461Gerceker GO, Bektas M, Aydinok Y, Oren H, Ellidokuz H, Olgun N. The effect of virtual reality on pain, fear, and anxiety during access of a port with huber needle in pediatric hematology-oncology patients: Randomized controlled trial. Eur J Oncol Nurs. 2021 Feb;50:101886. doi: 10.1016/j.ejon.2020.101886. Epub 2020 Dec 1.
- BackgroundFraser LK, Gibson-Smith D, Jarvis S, Norman P, Parslow R. 'Make Every Child Count' Estimating current and future prevalence of children and young people with life-limiting conditions in the United Kingdom FINAL REPORT FEBRUARY 2020. 2020;(February):1-61
- BackgroundFoundation WBF. Wong-Baker FACES® Pain Rating Scale. 2016.
- Background: PubMed 31785015Caruso TJ, George A, Menendez M, De Souza E, Khoury M, Kist MN, Rodriguez ST. Virtual reality during pediatric vascular access: A pragmatic, prospective randomized, controlled trial. Paediatr Anaesth. 2020 Feb;30(2):116-123. doi: 10.1111/pan.13778. Epub 2019 Dec 19.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iveta Fajnerova, MSc, PhD study chair
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation virtual reality (VR) and Experiential virtual reality (VR) in people with Pediatric Palliative Care and Life Limiting Conditions, run by National Institute of Mental Health, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention. (time frame: Baseline and 15 minutes (post intervention).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06915883, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.