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Biofeedback With Heart Sound Following Trauma

Biofeedback With Heart Sound Following Trauma

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06919055
Enrollment
42
Registered
2025-04-09
Start date
2025-03-01
Completion date
2025-12-31
Last updated
2025-04-23

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

Conditions

Young Earthquake Survivors

Keywords

biofeedback, trauma, allostasis

Brief summary

The Project aims to assess the long-term risk of trauma-induced stress in young persons. Using non-invasive sound therapy to assess the effects on the vagal nerve via cardiovascular effects and neural activity will provide biofeedback in these individuals.

Detailed description

Background: Some countries have suffered and will continue to suffer great destruction as a result of wars, epidemics, earthquakes, and other natural catastrophes. When individuals are exposed to specific psychological or physical traumas, they can develop stress-related disorders. This can lead to irreversible changes in the autonomic nervous system and cardiovascular disorders. When subjected to a new stress test, traumatized/previously exposed participants may show more pronounced behavioral changes, intolerance, and greater fatigue responses as compared to pre-trauma. To reduce trauma-associated responses from recurring again in the future, especially in young people, it is necessary to take preventive measures. Alternative solutions must be designed for counseling, medication, phytotherapy, etc. This study aims to examine how individuals cope with trauma-related situations using a biofeedback method, which could be developed to manage stress-related coping. The emotional and psychological states of earthquake victims will be assessed using a protocol based on biomedical (neuro-cardiac) signals and the sound of the person's own heart. This sound will be applied at a fixed frequency or in real-time with allostatic auditory stimulation. A resonance stabilizing the autonomic nervous system will thus provide biofeedback to the participants. Methods: To examine the different states, biological signals will be measured and recorded, such as electrocardiography (ECG), phonocardiography (PCG), electrodermal activity, respiratory rhythm, and near-infrared spectroscopic imaging (fNIRS). Deep learning models will optimally process the collected data and evaluate the results. Impact: The Project aims to assess the long-term risk of trauma-induced stress in young persons. Using non-invasive sound therapy to assess the effects on the vagal nerve via cardiovascular effects and neural activity will provide biofeedback in these individuals.

Interventions

OTHERPCG auditory stimulation

PCG auditory stimulation during mental stress

OTHERMHR stimulation

MHR auditory stimulation during mental stress

no stimulation during mental stress

Sponsors

The Scientific and Technological Research Council of Turkey
CollaboratorOTHER
Fatma Özcan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

Control group: 10 young 'healthy' earthquake survivors will not receive any auditory stimulation. 1. Intervention group: 10 young 'healthy' earthquake survivors will be subjected to a closed circuit, real-time heart sound (PCG) (to create biofeedback). 2. Intervention group: 10 young 'healthy' earthquake survivors will be given an auditory stimulus of their heart sound and average heart rate-MHR (or a metronome in heart rhythm) taken while calm.

Eligibility

Sex/Gender
ALL
Age
20 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

* 30 earthquake survivor university students between 20 and 25 will participate in the experiment. Participants will be healthy, non-obese men (n=15) and women (n=15). In particular, all participants should have experienced the earthquake disaster in the local region. All participants must be free of any chronic or acute infection, neurological, psychiatric, and/or cardiovascular disease.

Exclusion criteria

* They must be non-smokers, have no alcohol or drug addiction, and not be under any medical treatment. Pregnant or breastfeeding women will not be included in the study.

Design outcomes

Primary

MeasureTime frameDescription
Primary outcome2 monthsIn order to carry out this study, the following basic measurements (gender, age, height, weight, blood pressure, etc.) and relative measurements from the basic measurements will be extracted. In this context, earthquake victims' cardiological, emotional, and psychological states will be observed through biomedical signals. From electrocardiogram (ECG), HRV, LF, HF, LF/HF, SDNN, and RMSSD parameters will be assessed to evaluate the autonomic nervous system, especially the parasympathetic nervous system. The fNIRS device will measure changes in oxygenated and deoxygenated hemoglobin concentration in the cortical structure of the forebrain, as well as markers of cardiovascular and psychological risk.

Secondary

MeasureTime frameDescription
Others biopotentials2 monthsOur protocol will measure the electrodermal activity signal in microsiemens. The respiratory rythme is measured in milliVolt.

Countries

Turkey (Türkiye)

Contacts

Primary ContactFatma Özcan
fatma.ozcan13@gmail.com+905412385185

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026