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

National Institute of Mental Health, Czech Republic

Status: Enrolling

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

Treatments: Device: Experiential virtual reality (VR); Device: Relaxation virtual reality (VR)

Study type: Interventional

Funder types: Other

Identifiers

NCT06915883

EK-670/24

187724 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

ARM 1: relaxation VR followed by experiential VR

Experimental group

Treatment:

Device: Relaxation virtual reality (VR)

Device: Experiential virtual reality (VR)

ARM 2: experiential VR followed by relaxation VR

Experimental group

Treatment:

Device: Relaxation virtual reality (VR)

Device: Experiential virtual reality (VR)