Life Limiting Conditions, Life Threatening Diseases, Pediatric Palliative Care
Conditions
Keywords
experiential VR, relaxation VR, modern technologies in supportive care in medicine, pediatric palliative care, virtual reality, anxiety reduction, pediatric
Brief 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).
Interventions
DEVICERelaxation 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).
DEVICEExperiential 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.
Sponsors
National Institute of Mental Health, Czech Republic
Motol University Hospital
Charles University, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention. | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention. | 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. |
| Change in Fear Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention. | 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. |
Countries
Czechia
Contacts
STUDY_CHAIRIveta Fajnerova, MSc, PhD
National Institute of Mental Health (NIMH)
Outcome results
None listed