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临床试验/NCT06919055
NCT06919055招募中不适用

Biofeedback With Heart Sound Following Trauma

Fatma Özcan1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
42
试验地点
1
主要终点
Primary outcome

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

control

Active Comparator

no stimulation during mental stress

干预措施: Control-no treatment (Other)

PCG auditory stimulation group

Experimental

PCG auditory stimulation during mental stress

干预措施: PCG auditory stimulation (Other)

metronome in heart rhythm stimulation group

Experimental

MHR (or a metronome in heart rhythm) stimulation during mental stress

干预措施: MHR stimulation (Other)

结局指标

主要结局

Primary outcome

时间窗: 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.

次要结局

  • Others biopotentials(2 months)

研究者

发起方
Fatma Özcan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fatma Özcan

PhD Lecturer

Kahramanmaras Sutcu Imam University

研究点 (1)

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