Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 187724 | Other Grant/Funding Number | Charles University Grant Agency |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Motol University Hospital | OTHER |
| Charles University, Czech Republic | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 1: relaxation VR followed by experiential VR | Experimental |
| |
| ARM 2: experiential VR followed by relaxation VR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Levels from Baseline following Experiential and Relaxation Virtual Reality 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Parents' Opinion on the VR Relaxation and Experiential Interventions for Children/Child Patients. | Verbal opend-ended question on how the caregivers of the child patient perceive the VR intervention. This outcome is analysed qualitatively. | From enrollement of the child to the end of second session (approximately 4 weeks from enrollement). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Iveta Fajnerova, MSc, PhD | National Institute of Mental Health (NIMH) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Motol | Prague | Czech Republic | 15006 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Toman J. Škály na měření úzkosti a úzkostlivosti u dětí. Praha: Národní ústav pro vzdělávání; 2018. | ||
| 21806301 | 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. | |
| 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. | ||
| 33321461 |
Not provided
Not provided
Individual participant data (IPD) will be shared in respect to the outcome measures (baseline and post-treatment), meaning pre-processed data of individuals related to the study's outcome measures. All data will be anonymized, with each participant's data stored under a unique individual code.
Not provided
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.
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.
Not provided
Not provided
Two virtual reality interventions (experiential and relaxation) are provided to subjects at different time periods, the sequence of treatments is randomized for each subject.
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| Baseline and 15 minutes (post intervention). |
| Change in Fear Levels from Baseline following Experiential and Relaxation Virtual Reality 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. | Baseline and 15 minutes (post intervention). |
| 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. |
| 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. |
| 31785015 | 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. |