Меню
Идёт набор NCT07386951

Heart Rate Variability Biofeedback in Security Forces

Без фазы С лечением Psychological Distress Well-Being, Psychological Burnout

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Heart Rate Variability Biofeedback (HRV-BFB) Training.
Кому может быть актуально
Состояния в реестре: Psychological Distress, Well-Being, Psychological, Burnout. Базовые параметры: 18 лет — 55 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Португалия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Heart Rate Variability Biofeedback in Distress Regulation and Burnout Prevention Among Security Forces

Обзор

This exploratory study evaluates the effectiveness of a 12-session Heart Rate Variability Biofeedback (HRV-BFB) protocol in reducing distress and burnout while promoting psychological well-being among Portuguese National Republican Guard (GNR) professionals. Exposed to high occupational stress from unpredictable risks, shift work, and limited resources, these individuals face elevated vulnerability to chronic stress outcomes. The intervention leverages real-time HRV feedback to enhance autonomic regulation, breathing techniques, and emotional self-regulation.

Подробное описание

Security forces like the GNR play a critical role in public safety but endure chronic stress from violence exposure, rapid decisions, shift rotations, and institutional resource shortages, heightening risks of distress, burnout, and impaired well-being. Distress arises when perceived threats exceed coping resources, leading to persistent negative emotions and health disruptions. Burnout manifests as exhaustion, mental distancing, and reduced efficacy from unmanaged chronic stress, with organizational impacts including absenteeism and eroded public trust. Psychological well-being encompasses multidimensional aspects like autonomy, relationships, and purpose beyond mere absence of illness. Traditional interventions face barriers such as stigma and access issues in rural GNR contexts, necessitating flexible, self-administered tools.

Intervention: HRV-BFB Protocol HRV-BFB trains participants to consciously modulate physiological responses via real-time monitoring of heart rate variability (HRV), reflecting sympathetic-parasympathetic balance. Low HRV links to mental health risks, while training targets resonance frequency breathing (\~6 breaths/min or 0.1 Hz) to boost HRV amplitude, cardiac coherence, and baroreflex strength. Delivered autonomously via app post-initial guidance, the 12-session protocol requires no daily clinician oversight, enhancing accessibility for dispersed GNR personnel. Evidence shows HRV-BFB reduces stress, anxiety, depression, and burnout while fostering well-being in high-stress groups like emergency workers.

Study Objectives This exploratory trial tests whether HRV-BFB significantly lowers distress (multidimensional: physical, cognitive, emotional, behavioral), burnout levels, and boosts psychological well-being in GNR professionals. It aims to inform scalable interventions tailored to Portuguese police realities, addressing gaps in institutional support.

Вмешательства

  • Поведенческое Heart Rate Variability Biofeedback (HRV-BFB) Training
    Participants receive a structured heart rate variability biofeedback (HRV-BFB) training protocol delivered over 4 weeks. The intervention uses a portable chest-worn ECG sensor (eSense Pulse) connected via Bluetooth to a mobile application that provides real-time visual feedback of heart rate variability. Each participant completes 12 individual sessions of 12 minutes each (one session every 2 days). Sessions take place in a quiet room and follow a standardized format: a brief preparation phase,

Первичные конечные точки

  • Change in Psychological Distress (Kessler Psychological Distress Scale - K10) [Срок оценки: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 10)]
  • Change in Occupational Burnout (Burnout Assessment Tool - BAT-12) [Срок оценки: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 10)]
  • Change in Psychological Well-Being (WHO-5 Well-Being Index) [Срок оценки: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 10)]
Вторичные конечные точки (3)
  • SDNN (Standard Deviation of NN Intervals) - Heart Rate Variability [Срок оценки: Baseline (Week 0), after each of 12 training sessions]
  • RMSSD (Root Mean Square of Successive Differences) - Parasympathetic Activity [Срок оценки: Baseline (Week 0), after each of 12 training sessions]
  • Stress Index - Autonomic Balance Indicator [Срок оценки: Baseline (Week 0), after each of 12 training sessions]

Критерии участия

Критерии включения

  • Operational military personnel of the Guarda Nacional Republicana (GNR) performing security, patrol, criminal investigation, or road safety duties
  • Any military rank or professional category within operational roles
  • Age between 18 and 55 years, inclusive
  • Both males and females
  • Capable of providing informed consent in Portuguese language

Критерии исключения

  • Extended sick leave or medical absence
  • Currently involved in serious disciplinary proceedings
  • Use, modification, or initiation of psychotropic medication (including antidepressants, anti-anxiety medications, antipsychotics, mood stabilizers) within the past 6 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Португалия · 1 центр
  • GNR - Comando Terrritorial de Setúbal (GNR - Setubal Territorial Command Centre) — Setúbal

Идентификаторы

NCT: NCT07386951 · PT-214/25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗