Young Earthquake SurvivorsNCT06919055
Biofeedback With Heart Sound Following Trauma
A study testing PCG auditory stimulation and MHR stimulation in people with Young Earthquake Survivors, run by Fatma Özcan at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 25 years
- Conditions the study is for
- Young Earthquake Survivors
- What is being tested?
- PCG auditory stimulation and MHR stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kahramanmaras
Kahramanmaraş, 46000
About this study
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.
Read the 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.
- Conditions
- Young Earthquake Survivors
- Being tested
- PCG auditory stimulation, MHR stimulation, Control-no treatment
- Keywords
- biofeedback, trauma, allostasis
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCG auditory stimulationOther
PCG auditory stimulation during mental stress
MHR stimulationOther
MHR auditory stimulation during mental stress
Control-no treatmentOther
no stimulation during mental stress
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | no stimulation during mental stress Receives: Other: Control-no treatment |
| PCG auditory stimulation group | Experimental | PCG auditory stimulation during mental stress Receives: Other: PCG auditory stimulation |
| metronome in heart rhythm stimulation group | Experimental | MHR (or a metronome in heart rhythm) stimulation during mental stress Receives: Other: MHR stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
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.
Measured: 2 months
Secondary outcomes (1)
Others biopotentials
Our protocol will measure the electrodermal activity signal in microsiemens. The respiratory rythme is measured in milliVolt.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Mar 2025
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Young Earthquake SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatma Özcan
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Fatma Özcan, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919055
- Sponsor's protocol ID
- ALLOSTAT0001
- Status last verified
- Apr 2025
- First submitted
- 17 Mar 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patron E, Calcagni A, Thayer JF, Scrimin S. The longitudinal negative impact of early stressful events on emotional and physical well-being: The buffering role of cardiac vagal development. Dev Psychobiol. 2021 Jul;63(5):1146-1155. doi: 10.1002/dev.22066. Epub 2020 Dec 11.
PubMed 33314062Parizek D, Visnovcova N, Hamza Sladicekova K, Veternik M, Jakus J, Jakusova J, Visnovcova Z, Ferencova N, Tonhajzerova I. Effect of Selected Music Soundtracks on Cardiac Vagal Control and Complexity Assessed by Heart Rate Variability. Physiol Res. 2023 Nov 28;72(5):587-596. doi: 10.33549/physiolres.935114.
PubMed 38015758Nakajima Y, Tanaka N, Mima T, Izumi SI. Stress Recovery Effects of High- and Low-Frequency Amplified Music on Heart Rate Variability. Behav Neurol. 2016;2016:5965894. doi: 10.1155/2016/5965894. Epub 2016 Aug 30.
PubMed 27660396Lee SW, Laurienti PJ, Burdette JH, Tegeler CL, Morgan AR, Simpson SL, Gerdes L, Tegeler CH. Functional Brain Network Changes Following Use of an Allostatic, Closed-Loop, Acoustic Stimulation Neurotechnology for Military-Related Traumatic Stress. J Neuroimaging. 2019 Jan;29(1):70-78. doi: 10.1111/jon.12571. Epub 2018 Oct 10.
PubMed 30302866Guannan, X., Xin, Z., Anchen, G., Siyang, H., Huijie, L., Jing, D., Qianqian, Z., & Jian, J. (2023). Phase-locked auditory pulse stimulation at home enhancing slow sleep waves: A pilot real-world study. medRxiv.
Gerdes L, Gerdes P, Lee SW, H Tegeler C. HIRREM: a noninvasive, allostatic methodology for relaxation and auto-calibration of neural oscillations. Brain Behav. 2013 Mar;3(2):193-205. doi: 10.1002/brb3.116. Epub 2013 Jan 14.
PubMed 23532171Fioranelli M, Bottaccioli AG, Bottaccioli F, Bianchi M, Rovesti M, Roccia MG. Stress and Inflammation in Coronary Artery Disease: A Review Psychoneuroendocrineimmunology-Based. Front Immunol. 2018 Sep 6;9:2031. doi: 10.3389/fimmu.2018.02031. eCollection 2018.
PubMed 30237802Adiasto K, Beckers DGJ, van Hooff MLM, Roelofs K, Geurts SAE. Music listening and stress recovery in healthy individuals: A systematic review with meta-analysis of experimental studies. PLoS One. 2022 Jun 17;17(6):e0270031. doi: 10.1371/journal.pone.0270031. eCollection 2022.
PubMed 35714120Ozcan F, Alkan A, Goswami N, Yildirim A, Ekersular MN, Oguzhan B. Biofeedback with heart sounds following a traumatic event. Front Psychol. 2026 Sep 8;17:1818000. doi: 10.3389/fpsyg.2026.1818000. eCollection 2026.
PubMed 42774140
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback With Heart Sound Following Trauma
- ClinicalTrials.gov ID
- NCT06919055
- Acronym / sponsor ID
- ALLOSTAT0001
- Conditions
- Young Earthquake Survivors
- Keywords
- biofeedback, trauma, allostasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Fatma ÖzcanUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: Control-no treatmentno stimulation during mental stress |
| PCG auditory stimulation group | Experimental | Other: PCG auditory stimulationPCG auditory stimulation during mental stress |
| metronome in heart rhythm stimulation group | Experimental | Other: MHR stimulationMHR (or a metronome in heart rhythm) stimulation during mental stress |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCG auditory stimulationPCG auditory stimulation during mental stress | Other | PCG auditory stimulation group |
| MHR stimulationMHR auditory stimulation during mental stress | Other | metronome in heart rhythm stimulation group |
| Control-no treatmentno stimulation during mental stress | Other | control |
Primary outcome
Primary outcome
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.
1 secondary outcome
Others biopotentials
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Results publication: PubMed 33314062Patron E, Calcagni A, Thayer JF, Scrimin S. The longitudinal negative impact of early stressful events on emotional and physical well-being: The buffering role of cardiac vagal development. Dev Psychobiol. 2021 Jul;63(5):1146-1155. doi: 10.1002/dev.22066. Epub 2020 Dec 11.
- Results publication: PubMed 38015758Parizek D, Visnovcova N, Hamza Sladicekova K, Veternik M, Jakus J, Jakusova J, Visnovcova Z, Ferencova N, Tonhajzerova I. Effect of Selected Music Soundtracks on Cardiac Vagal Control and Complexity Assessed by Heart Rate Variability. Physiol Res. 2023 Nov 28;72(5):587-596. doi: 10.33549/physiolres.935114.
- Results publication: PubMed 27660396Nakajima Y, Tanaka N, Mima T, Izumi SI. Stress Recovery Effects of High- and Low-Frequency Amplified Music on Heart Rate Variability. Behav Neurol. 2016;2016:5965894. doi: 10.1155/2016/5965894. Epub 2016 Aug 30.
- Results publication: PubMed 30302866Lee SW, Laurienti PJ, Burdette JH, Tegeler CL, Morgan AR, Simpson SL, Gerdes L, Tegeler CH. Functional Brain Network Changes Following Use of an Allostatic, Closed-Loop, Acoustic Stimulation Neurotechnology for Military-Related Traumatic Stress. J Neuroimaging. 2019 Jan;29(1):70-78. doi: 10.1111/jon.12571. Epub 2018 Oct 10.
- Results publicationGuannan, X., Xin, Z., Anchen, G., Siyang, H., Huijie, L., Jing, D., Qianqian, Z., & Jian, J. (2023). Phase-locked auditory pulse stimulation at home enhancing slow sleep waves: A pilot real-world study. medRxiv.
- Results publication: PubMed 23532171Gerdes L, Gerdes P, Lee SW, H Tegeler C. HIRREM: a noninvasive, allostatic methodology for relaxation and auto-calibration of neural oscillations. Brain Behav. 2013 Mar;3(2):193-205. doi: 10.1002/brb3.116. Epub 2013 Jan 14.
- Results publication: PubMed 30237802Fioranelli M, Bottaccioli AG, Bottaccioli F, Bianchi M, Rovesti M, Roccia MG. Stress and Inflammation in Coronary Artery Disease: A Review Psychoneuroendocrineimmunology-Based. Front Immunol. 2018 Sep 6;9:2031. doi: 10.3389/fimmu.2018.02031. eCollection 2018.
- Results publication: PubMed 35714120Adiasto K, Beckers DGJ, van Hooff MLM, Roelofs K, Geurts SAE. Music listening and stress recovery in healthy individuals: A systematic review with meta-analysis of experimental studies. PLoS One. 2022 Jun 17;17(6):e0270031. doi: 10.1371/journal.pone.0270031. eCollection 2022.
- Derived from this study: PubMed 42774140Ozcan F, Alkan A, Goswami N, Yildirim A, Ekersular MN, Oguzhan B. Biofeedback with heart sounds following a traumatic event. Front Psychol. 2026 Sep 8;17:1818000. doi: 10.3389/fpsyg.2026.1818000. eCollection 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCG auditory stimulation and MHR stimulation in people with Young Earthquake Survivors, run by Fatma Özcan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Özcan (+905412385185, fatma.ozcan13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06919055, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.