Experiential and Relaxation Virtual Reality as a Tool for Easing Anxiety in Seriously Ill Children
NCT ID: NCT06915883
Last Updated: 2025-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-12-20
2025-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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ARM 1: relaxation VR followed by experiential VR
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).
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.
ARM 2: experiential VR followed by relaxation VR
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).
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.
Interventions
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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).
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* unstable health status
* inability to speak Czech
* absence of parental consent for participation in the study
7 Years
17 Years
ALL
No
Sponsors
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Motol University Hospital
OTHER
Charles University, Czech Republic
OTHER
National Institute of Mental Health, Czech Republic
OTHER
Responsible Party
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Anna Zubková
Principal Investigator
Principal Investigators
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Iveta Fajnerova, MSc, PhD
Role: STUDY_CHAIR
National Institute of Mental Health (NIMH)
Locations
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University Hospital Motol
Prague, Czech Republic, Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Fraser 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.
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.
Kennedy 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.
Other Identifiers
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187724
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
EK-670/24
Identifier Type: -
Identifier Source: org_study_id
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