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Clinical Trials in Turkey / NCT06919055
Recruiting Not applicable

Biofeedback With Heart Sound Following Trauma

NCT06919055 · tracked via the Priya Life Science Turkey tracker
Sponsor
Fatma Özcan
Phase
Not applicable
Started
2025-03-01
Last updated
2025-04-23

Condition(s) studied

Young Earthquake Survivors

Investigational drug(s) / intervention(s)

PCG auditory stimulationMHR stimulationControl-no treatment

PCG auditory stimulation: PCG auditory stimulation during mental stress

MHR stimulation: MHR auditory stimulation during mental stress

Control-no treatment: no stimulation during mental stress

Study 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
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.

Primary outcome measure(s)

  • Primary outcome — 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.

Trial sites (1)

FacilityCityRegionStatus
Kahramanmaras Kahramanmaraş Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06919055 on ClinicalTrials.gov ↗ ← All trials in Turkey