Virtual reality mediated deep breathing and relaxation training in pediatric and psychiatric care
| ISRCTN | ISRCTN12712970 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12712970 |
- Submission date
- 13/05/2025
- Registration date
- 23/05/2025
- Last edited
- 23/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Virtual reality techniques have been used for various purposes in healthcare to find novel ways to treat different medical conditions and to prepare patients for unpleasant procedures. The study aims to create virtual reality applications for children for learning deep breathing and relaxation, and to study their effectiveness, safety and usability in different child patient groups. The main goal is to learn if virtual reality-mediated deep breathing and relaxation training can reduce experiences of stress and anxiety via autonomic nervous system stimulation.
Who can participate?
The participants are child patients aged 8-17 years.
What does the study involve?
The participants perform either guided deep breathing or relaxation exercises using a virtual reality headset. The exercise is guided by a bot figure providing verbal instructions in a virtual nature environment.
What are the possible benefits and risks of participating?
The study patients receive the benefit of a learning experience of the guided deep breathing or relaxation exercise. The possible risk is having nausea or vertigo, which are occasionally reported during the use of a virtual reality headset.
Where is the study run from?
Tampere University Hospital (Finland)
When is the study starting and how long is it expected to run for?
May 2022 to June 2024
Who is funding the study?
1. Tampere University (Finland)
2. The Finnish Foundation for Pediatric Research (Finland)
3. Finnish Brain Foundation (Finland)
4. Päivikki and Sakari Sohlberg Foundation (Finland)
Who is the main contact?
MD, PhD Sauli Palmu, sauli.palmu@tuni.fi
Contact information
Public, Scientific
Tampere University
Ranta-Tampellan katu 12 A 10
Tampere
33180
Finland
 ORCID ID |
0009-0007-1763-7947 |
|---|---|
| Phone | +358 44 57 44 826 |
| elina.karppa@tuni.fi |
Principal Investigator
Tampere University Hospital
Elämänaukio 2
Tampere
33520
Finland
| ORCID ID |
0000-0003-3270-7660 |
|---|---|
| Phone | +358 40 7352566 |
| sauli.palmu@tuni.fi |
Study information
| Study design | Multicenter interventional randomized controlled pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The effect of virtual reality mediated deep breathing and relaxation training on stress and anxiety in child patients: a pilot trial |
| Study acronym | VirNE |
| Study objectives | Deep breathing and relaxation training reduce stress and anxiety in child patients. |
| Ethics approval(s) |
Approved 15/06/2021, The Ethics Committee of the Wellbeing Services County of Pirkanmaa (PL 2000, Tampere, 33521, Finland; +358 50 347 0251, +358 50 329 5667; toimikunta.eettinen@pirha.fi), ref: RL21070L |
| Health condition(s) or problem(s) studied | Reduxing anxiety and stress in child patients |
| Intervention | The patients are allocated to either the intervention or the control group in numerical order. The intervention is virtual reality-mediated deep breathing or relaxation training. The study patients perform a 6-minute deep breathing or relaxation exercise with a virtual reality headset in the pediatric unit, observing a 360-degree virtual Finnish nature environment and a bot figure providing the patient with verbal guidance throughout the exercise. The study patients will perform the exercise once (in a distraction group) or four times (in a training group; one session per week in a 4-week period). During the exercise, heart rate variability is measured using a heart rate sensor belt ( a chest strap). The control intervention is no treatment. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oculus Quest 2 - virtual reality headset |
| Primary outcome measure | Heart rate variability measured using the virtual reality headset during the research situation |
| Secondary outcome measures | Heart rate and user feedback measured using the virtual reality headset during the research situation |
| Overall study start date | 01/01/2021 |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 220 |
| Key inclusion criteria | 1. Child patients aged 8-17 years 2. Literate 3. Fluent in Finnish |
| Key exclusion criteria | 1. Unstable heart condition 2. Anatomical facial features preventing the use of the headset 3. Hearing impairment or cochlear implant 4. Vision impairment 5. Tendency for vertigo 6. Clinically unevaluated seizures 7. Epilepsy 8. Migraine 9. Bulimia nervosa 10. Relative exclusion criteria: motion sickness, underweight |
| Date of first enrolment | 04/05/2022 |
| Date of final enrolment | 30/06/2024 |
Locations
Countries of recruitment
- Finland
Study participating centres
Tampere
33520
Finland
Lahti
15850
Finland
Sponsor information
University/education
Kanslerinrinne 1
Tampere
33100
Finland
| Phone | +358 (0)29 45211 |
|---|---|
| tau@tuni.fi | |
| Website | https://www.tuni.fi/en |
"ROR" |
https://ror.org/033003e23 |
Funders
Funder type
University/education
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analyzed during the current study are not publicly available due ethical and data privacy issues in healthcare, but are partly available from Elina Karppa (elina.karppa@tuni.fi) upon reasonable request. Consent from the participants was required and obtained; data is anonymised with ID codes. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3 | 14/05/2025 | 23/05/2025 | No | No |
Additional files
Editorial Notes
14/05/2025: Study's existence confirmed by the regional medical research ethics committee of the special responsibility area of Tampere University Hospital.
