Kahramanmaras
Kahramanmaraş, 46000, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT06919055
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.
Interested in participating?
Request Info20 year–25 year
All sexes
Interventional
Not applicable
Kahramanmaraş, 46000, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PCG auditory stimulation during mental stress
MHR auditory stimulation during mental stress
no stimulation during mental stress
Time frame: 2 months
In 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.
Time frame: 2 months
Our protocol will measure the electrodermal activity signal in microsiemens. The respiratory rythme is measured in milliVolt.
Contact information is provided by the study sponsor or research team.
Fatma Özcan
Other
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