Biofeedback With Heart Sound Following Trauma

NCT ID: NCT06919055

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-12-31

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.

Conditions

Young Earthquake Survivors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

control

no stimulation during mental stress

Group Type: ACTIVE_COMPARATOR

Control-no treatment

Intervention Type: OTHER

no stimulation during mental stress

PCG auditory stimulation group

PCG auditory stimulation during mental stress

Group Type: EXPERIMENTAL

PCG auditory stimulation

Intervention Type: OTHER

PCG auditory stimulation during mental stress

metronome in heart rhythm stimulation group

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

Group Type: EXPERIMENTAL

MHR stimulation

Intervention Type: OTHER

MHR auditory stimulation during mental stress

Interventions

PCG auditory stimulation

PCG auditory stimulation during mental stress

Intervention Type: OTHER

MHR stimulation

MHR auditory stimulation during mental stress

Intervention Type: OTHER

Control-no treatment

no stimulation during mental stress

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Fatma Özcan

OTHER

Sponsor Role: lead

Responsible Party

Fatma Özcan

PhD Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Kahramanmaras

Kahramanmaraş, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Fatma Özcan

Role: CONTACT

fatma.ozcan13@gmail.com

+905412385185

References

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Reference Type: BACKGROUND

PMID: 33314062 (View on PubMed)

Parizek 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.

Reference Type: BACKGROUND

PMID: 38015758 (View on PubMed)

Nakajima 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.

Reference Type: BACKGROUND

PMID: 27660396 (View on PubMed)

Lee 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.

Reference Type: BACKGROUND

PMID: 30302866 (View on PubMed)

Guannan, 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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 23532171 (View on PubMed)

Fioranelli 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.

Reference Type: BACKGROUND

PMID: 30237802 (View on PubMed)

Adiasto 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.

Reference Type: BACKGROUND

PMID: 35714120 (View on PubMed)

Other Identifiers

ALLOSTAT0001

Identifier Type: -

Identifier Source: org_study_id