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

NCT06915883 | Completed

• 2 other identifiers: EK-670/24187724
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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:

• 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).

Conditions

Pediatric Palliative Care; Life Limiting Conditions; Life Threatening Diseases

Keywords

experiential VR; relaxation VR; modern technologies in supportive care in medicine; pediatric palliative care; virtual reality; anxiety reduction; pediatric

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  3-5 minutes post VR intervention

Secondary Outcomes (2)

• Change in Pain Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention.

  Baseline and 15 minutes (post intervention).

• Change in Fear Levels from Baseline following Experiential and Relaxation Virtual Reality Intervention.

  Baseline and 15 minutes (post intervention).

Other Outcomes (1)

• Parents' Opinion on the VR Relaxation and Experiential Interventions for Children/Child Patients.

  From enrollement of the child to the end of second session (approximately 4 weeks from enrollement).

Study Arms (2)

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)

Interventions

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).

ARM 1: relaxation VR followed by experiential VR; ARM 2: experiential VR followed by relaxation VR

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.

ARM 1: relaxation VR followed by experiential VR; ARM 2: experiential VR followed by relaxation VR

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• age below 7 or above 17.9 years
• unstable health status
• inability to speak Czech
• absence of parental consent for participation in the study

Sponsors & Collaborators

• National Institute of Mental Health, Czech Republic: lead
• Motol University Hospital: collaborator
• Charles University, Czech Republic: collaborator

Study Sites (1)

University Hospital Motol

Prague, Czech Republic, 15006, Czechia

Location

Related Publications (7)

• Toman J. Škály na měření úzkosti a úzkostlivosti u dětí. Praha: Národní ústav pro vzdělávání; 2018.

  BACKGROUND

• 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.

  PMID: 21806301 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33321461 BACKGROUND

• 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

  BACKGROUND

• Foundation WBF. Wong-Baker FACES® Pain Rating Scale. 2016.

  BACKGROUND

• 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.

  PMID: 31785015 BACKGROUND

Study Officials

• Iveta Fajnerova, MSc, PhD

  National Institute of Mental Health (NIMH)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two virtual reality interventions (experiential and relaxation) are provided to subjects at different time periods, the sequence of treatments is randomized for each subject.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: December 20, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 31, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD will be shared upon request once the entire project is completed and the study is published in a peer-reviewed impact journal in open-access mode.
• Access Criteria: The IPD can be accessed by anyone upon request to the authors of the study. The authors can be contacted via email, which will be provided in the study publication and on the registration website.

Locations

CZ (1)