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Stress management programme with virtual reality-based biofeedback

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11331226
Enrollment
100
Registered
2023-05-26
Start date
2022-04-21
Completion date
Unknown
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reduction of stress and stress-related symptoms in healthy individuals Mental and Behavioural Disorders

Interventions

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 supp

Sponsors

Eidgenössische Technische Hochschule Zürich
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Switzerland

Contacts

Public ContactRaphael Weibel
raweibel@ethz.ch+41 (0)44 632 76 06

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026