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Идёт набор NCT07255313

Strengthening Health Literacy in Healthcare Workers Through Mind Body Medicine and Nutrition

Без фазы С лечением Stress Resilience Stress Burnout Burnout Syndrome

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: SOULFOOD Programme.
Кому может быть актуально
Состояния в реестре: Stress Resilience, Stress, Burnout, Burnout Syndrome. Базовые параметры: от 18 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
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Strengthening Psycho-physiological and Psycho-emotional Competencies in Healthcare Workers Through Mind Body Medicine and Nutrition: A Randomized Controlled Trial

Обзор

This is a randomized controlled trial aiming to develop and evaluate a workplace health program to improve stress resilience and mental well-being among healthcare workers at University Medicine Essen using a participatory research design (including a steering committee composed of hospital staff, needs assessment through focus groups, and pilot testing). The intervention combines mind-body medicine techniques, complementary medicine self-care strategies, and psycho-biotic nutrition. If successful, the program will be integrated into routine workplace health management and serve as a model for other healthcare institutions.

Подробное описание

This participatory research study at University Medicine Essen aims to develop, implement, and evaluate a workplace health program to improve stress resilience and mental well-being among healthcare workers. Increasing stress, staff shortages, and high rates of sick leave negatively impact both employees and patient care, making a comprehensive and sustainable health program essential. To ensure the intervention meets employees' needs, the study is guided by a steering committee consisting of hospital staff from various departments, including occupational health management, sustainability management, reintegration services, and the nonscientific staff council. A preliminary needs assessment will be conducted through focus groups, allowing employees to provide input on key aspects such as session format, duration, and content. Furthermore, the intervention design will be tested in a pilot phase to ensure the design is feasible and accepted by the participants.

The intervention will be a multimodal program combining mind-body medicine techniques, complementary self-care, and psycho-biotic nutrition to enhance stress resilience and overall health. Mind-body medicine includes mindfulness and stress management techniques, while complementary self-care will focus on easily applicable techniques from Traditional European Medicine (TEM) and Traditional Indian Medicine (TIM). Psycho-biotic nutrition, based on the connection between gut health and mental well-being, aims to support emotional and cognitive health through dietary changes. The study will use a randomized controlled trial design, comparing an intervention group with a waitlist control group to evaluate effectiveness.

Beyond individual benefits, the study also seeks to identify workplace-level improvements by promoting mindfulness among employees and leadership regarding structural stressors. This includes optimizing communication, understanding one's thoughts and emotions, and improving workplace policies such as break structures to better support employee well-being. By integrating feedback from the needs assessment and the pilot phase, the study aims to develop a sustainable and evidence-based health program that can be incorporated into routine workplace health management at University Medicine Essen. If successful, the intervention will serve as a model for other healthcare institutions and may be implemented more broadly within the healthcare sector.

Вмешательства

  • Поведенческое SOULFOOD Programme
    This arm is a 10-week multimodal program designed to enhance resilience and health competencies. Participants engage in structured weekly intervention sessions lasting 2 hours and homework activities. These sessions are delivered in person, with flexible scheduling to accommodate work schedules. The intervention focuses on mind-body medicine, complementary medicine and nutrition. Core components include psycho-biotic nutrition, movement, relaxation techniques, and complementary self-care techniq

Первичные конечные точки

  • Stress Resilience [Срок оценки: Week 10]
Вторичные конечные точки (12)
  • Burnout [Срок оценки: Week 10]
  • Stress Coping [Срок оценки: Week 10]
  • Stress Symptoms [Срок оценки: Week 10]
  • Physical Resilience [Срок оценки: Week 10]
  • Mental Well-Being [Срок оценки: Week 10]
  • Psychological Distress [Срок оценки: Week 10]
  • Health Behaviour Change [Срок оценки: Week 10]
  • Adverse Events [Срок оценки: From enrollment to the end of treatment at week 10]
  • Stress Resilience [Срок оценки: Week 26]
  • Burnout [Срок оценки: Week 26]
  • Stress Coping Strategies [Срок оценки: Week 26]
  • Stress Symptoms [Срок оценки: Week 26]

Критерии участия

Критерии включения

  • Age 18 years and older
  • Employees of University Medicine Essen
  • Moderate resilience of ≤ 144 points on the RS-25
  • Willingness to practice at home and keep a practice diary

Критерии исключения

  • Insufficient German language skills
  • Pregnancy and breastfeeding
  • Severe comorbid mental disorders (e.g., substance use disorder, major depression) or other severe comorbid somatic diseases (e.g., oncological disease without remission, severe pre-existing cardiovascular disease, organ failure, other severe neurological disorders)
  • Planned or ongoing pension application (e.g., disability pension, occupational disability, reduced earning capacity, severe disability)
  • Concurrent participation in other clinical intervention studies

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Германия · 1 центр
  • Center for Integrative Medicine and Planetary Health, University Hospital Essen — Essen

Идентификаторы

NCT: NCT07255313 · 24-12325-BO

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗