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

Not Applicable

Recruiting

• Conditions: Pediatric Palliative Care; Life Limiting Conditions; Life Threatening Diseases

• Registration Number: NCT06915883
• Lead Sponsor: National Institute of Mental Health, Czech Republic

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-20
• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-03-31
• Study First Posted: 2025-04-08
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-15
• Last Update Posted: 2025-06-18
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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.
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

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University Hospital Motol; 🇨🇿 Prague, Czech republic, Czechia