Stress management programme with virtual reality-based biofeedback
| ISRCTN | ISRCTN11331226 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11331226 |
| Secondary identifying numbers | 2202-StressmanagmentVR |
- Submission date
- 26/05/2023
- Registration date
- 26/05/2023
- Last edited
- 14/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Stress is common and has negative effects on mental and physical health. This study aims to use a stress management method called heart rate variability biofeedback to reduce levels of stress in healthy adults. During a heart rate variability biofeedback training participants learn to control the activity of their heart. In order to teach participants, virtual reality technology is used to visualize changes in the heart’s activity in an engaging way. Practising this for a longer period of time can reduce stress levels and improve other stress-related symptoms such as anxiety or depression.
Who can participate?
Healthy volunteers aged 18-40 years
What does the study involve?
Participants are randomly allocated to one of two groups. Participants doing the heart rate variability biofeedback training will be compared to participants in a wait-list control group, which will receive the training only after the assessments. Both groups will be compared at three timepoints: before the training, 1 week after the training and 4 weeks after the training. During these assessments, the researchers measure the psychological and biological effects of the training.
What are the possible benefits and risks of participating?
Comparable studies show that several weeks of heart rate variability biofeedback training reduce stress significantly. This includes reducing perceived stress, anxiety, and depression, as well as improving quality of life and well-being. The training can also improve participants’ heart activity. Even if randomly assigned to the waitlist, participants have the option to do the training after the study to benefit from its effects. There are no direct disadvantages to participating, and there are no serious health risks. During the training short-term hyperventilation may occur, leading to dizziness and lightheadedness. Additionally, the use of virtual reality technology may temporarily cause a condition known as cybersickness, which includes symptoms such as eye strain, headaches, paleness, sweating, dry mouth, fullness, disorientation, dizziness, impaired coordination, nausea, and vomiting. However, these potential side effects of the training and virtual reality technology are rare and harmless.
Where is the study run from?
The Swiss Federal Institute of Technology in Zurich (Switzerland)
When is the study starting and how long is it expected to run for?
August 2021 to October 2022
Who is funding the study?
The Swiss Federal Institute of Technology in Zurich (Switzerland)
Who are the main contacts?
1. Doctoral student MSc. Raphael Weibel, raweibel@ethz.ch
2. Doctoral student MSc. Jasmine Kerr, jkerr@ethz.ch
Contact information
Principal Investigator
Weinbergstrasse 56/ 58
Zurich
8092
Switzerland
 ORCID ID |
0000-0003-3964-2353 |
|---|---|
| Phone | +41 (0)44 632 69 24 |
| fwangenheim@ethz.ch |
Scientific
Weinbergstrasse 56/ 58
Zürich
8092
Switzerland
| ORCID ID |
0000-0001-5093-3835 |
|---|---|
| Phone | +41 (0)44 632 65 83 |
| jkerr@ethz.ch |
Public
Weinbergstrasse 56/ 58
Zürich
8092
Switzerland
| ORCID ID |
0000-0002-8854-7507 |
|---|---|
| Phone | +41 (0)44 632 76 06 |
| raweibel@ethz.ch |
Study information
| Study design | Single-center interventional randomized wait-list controlled trial without blinding |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Evaluating the psychobiological effectiveness and user experience of virtual reality heart rate variability biofeedback intervention programme for stress management in healthy individuals: a randomized wait-list control trial |
| Study objectives | The virtual reality-supported heart rate variability biofeedback intervention programme will improve primary and secondary outcomes (i.e., stress and stress-related measures) from pre-intervention to post-intervention and from pre-intervention to follow-up compared to the wait-list control group. |
| Ethics approval(s) | Approved 15/03/2022, Ethics Commission of ETH Zurich (ETH Zürich, Stab Forschung, Weinbergstrasse 11, WEC E 15/17, 8092 Zürich, Switzerland; +41 (0)44 632 85 72; ethics@sl.ethz.ch), ref: 2022-N-35 |
| Health condition(s) or problem(s) studied | Reduction of stress and stress-related symptoms in healthy individuals |
| Intervention | The 4-week intervention programme investigated in this study includes four training sessions of heart rate variability biofeedback in virtual reality conducted weekly in the laboratory, which are supplemented by brief daily at-home exercises supported by a mobile application. The study also includes a wait-list control group. Participants (50% male and 50% female) will be randomly assigned to either the intervention group or the wait-list control group, which will both simultaneously undergo three assessments (pre-assessment during week 1 of the intervention, post-assessment in the week after the intervention and follow-up-assessment 4 weeks after the intervention). Randomisation takes place when participants sign up for their sessions. Experimenters have already pre-assigned groups to a specific day and time. Participants will only be informed about their group assignment after they have signed up. Randomisation was achieved by hidden pre-assigned groups (intervention or wail-list control) for each session participants could sign up for. Specifically, participants were able to select one of ten possible first sessions (i.e. in the first week), without knowing the hidden pre-assigned group of each sessions. Only after signing up for the study were the participants informed about the assigned group. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Levels of self-reported stress are measured using the Perceived Stress Scale (PSS) and the subscale Stress of the Depression, Anxiety and Depression Scales (DASS) before the intervention (PRE) and one (POST) and four (FOLLOW-UP) weeks after the intervention 2. Heart rate at rest measured using a wearable chest belt (Polar H10) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW-UP) weeks after the intervention. 3. Systolic and diastolic blood pressure at rest measured using a blood pressure monitor (Omron HBP-1120) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW-UP) weeks after the intervention 4. Heart rate variability features at rest measured using a wearable chest belt (Polar H10) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW-UP) weeks after the intervention 5. Levels of self-reported psychological state using a Visual Analogue Scale (VAS) and the Multidimensional Mood Questionnaire (MDMQ) are measured before, during and after a psychosocial stress test one week after the intervention (POST) 6. Salivary cortisol and salivary alpha-amylase measured using IBL-Tecan SaliCaps® and heart rate and heart rate variability features measured using the wearable chest belt Polar H10 before, during and after a psychosocial stress test 1 week after the intervention (POST) |
| Secondary outcome measures | 1. Levels of self-reported anxiety are measured using the DASS before the intervention (PRE) and 1 (POST) and 4 (FOLLOW-UP) weeks after the intervention 2. Levels of self-reported depression are measured using the DASS before the intervention (PRE) and 1 (POST) and 4 (FOLLOW-UP) weeks after the intervention 3. Levels of self-reported mindfulness are measured using the Mindfulness Attention and Awareness Scale (MAAS) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW-UP) weeks after the intervention 4. Levels of self-reported psychological well-being are measured using the World Health Organisation-Five Well-Being Index (WHO-5) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW-UP) weeks after the intervention 5. Levels of self-reported health-related quality of life are measured using the Short Form Health Survey (SF-36) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW-UP) weeks after the intervention 6. Levels of self-reported fatigue are measured using the Multidimensional Fatigue Inventory (MFI-20) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW-UP) weeks after the intervention 7. Levels of self-reported basic psychological needs satisfaction and frustration are measured using the Basic Psychological Need Satisfaction and Frustration Scale (BPNSFS) before the intervention (PRE) and 1 (POST) and 4 (FOLLOW-UP) weeks after the intervention |
| Overall study start date | 02/08/2021 |
| Completion date | 25/10/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Both |
| Target number of participants | 100 (50 per group) |
| Total final enrolment | 99 |
| Key inclusion criteria | 1. Fluent in German 2. Have normal or corrected-to-normal vision 3. Exhibit no disability of arms or hands 4. Have obtained at least a secondary school diploma 5. 18-40 years of age |
| Key exclusion criteria | 1. Self-reported acute (including common cold) and chronic somatic diseases (including epilepsy, photo epilepsy or other pre-existing neurological conditions) 2. Psychiatric disorders 3. Regular medication or medication in the last 2 months to treat acute illnesses, or any cardioactive medication (e.g., antidepressant, antipsychotic, antihypertensive), 4. The consumption of psychoactive substances in the last 3 months 5. Heavy drinking (equal or greater to 15 and equal or greater to 8 drinks per week for men and women, respectively) 6. Consumption of tobacco (more than 5 cigarettes/week). If participants report to smoke more than 5 cigarettes/week but only on weekends (e.g., social events, parties) they are not excluded. 7. Women with irregular menstrual cycles 8. Woman who use hormonal contraception, are pregnant or lactating |
| Date of first enrolment | 21/04/2022 |
| Date of final enrolment | 06/05/2022 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Zürich
8092
Switzerland
Sponsor information
University/education
Rämistrasse 101
Zürich
8092
Switzerland
| Phone | +41 (0)44 632 11 11 |
|---|---|
| gs@sl.ethz.ch | |
| Website | https://ethz.ch/en/ |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- ETH Zurich, ETH Zürich, Federal Institute of Technology Zurich, ETH Zürich (Eidgenössische Technische Hochschule Zürich), Eidgenössische Technische Hochschule Zürich (Switzerland), Eidgenössische Technische Hochschule Zürich (ETH), ethzurich, ETH
- Location
- Switzerland
Results and Publications
| Intention to publish date | 01/10/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/10/2023 | 14/11/2023 | Yes | No |
Editorial Notes
14/11/2023: The following changes were made to the trial record:
1. The participant level data sharing statement was added.
2. Publication reference added.
26/05/2023: Study's existence confirmed by the Ethics Commission of ETH Zurich.
