Diaphragmatic Breathing and Stimulation of the Autonomic Nervous System
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: Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E), Guided breathing at 6 bpm with apnea (A), Breathing education.
- Кому может быть актуально
- Состояния в реестре: Healthy Adult Male and Female Volunteers. 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
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Influence of Diaphragmatic Breathing Through Slow, Deep Respiration on Vagal Nerve Modulation and Stimulation of the Autonomic Nervous System
Обзор
Introduction: Slow, deep breathing has demonstrated beneficial effects on the autonomic nervous system, particularly by increasing parasympathetic activity through vagal nerve modulation. Previous studies suggest that this breathing pattern optimizes the sympathovagal balance, modifies physiological parameters such as heart rate, blood pressure, and oxygen saturation, and influences variables including heart rate variability (HRV) and RR intervals. Objectives: To analyze the effects of different slow deep breathing (SDB) training modalities on vagal tone regulation. Secondary objectives include evaluating their impact on heart rate and rhythm, HRV, cardiac beat intervals, blood pressure, and oxygen saturation. Methodology: A randomized, controlled, single-blind, parallel-design clinical trial will be conducted. Sixty healthy participants will be enrolled and allocated into three groups: two experimental groups (SDB with and without apnea) and one control group (breathing education). Pre- and post-intervention measurements will include HRV, RR intervals, heart rate, blood pressure, oxygen saturation, and cervical joint variables. Data will be analyzed using repeated-measures ANOVA and statistical tests appropriate for each variable type, with a significance level set at 5%. Expected Results: SDB-based interventions are expected to produce significant improvements in vagal regulation, increasing heart rate variability and favorably modifying the aforementioned physiological parameters compared with the control group.
Вмешательства
- Процедура Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E)
Spontaneous breathing in adults typically ranges between 12 and 20 breaths per minute (bpm), whereas slow, deep breathing (SDB) is usually performed as guided breathing at approximately 4 to 6 bpm. - Процедура Guided breathing at 6 bpm with apnea (A)
Spontaneous breathing in adults typically ranges between 12 and 20 breaths per minute (bpm), whereas slow, deep breathing (SDB) is usually performed as guided breathing at approximately 4 to 6 bpm. - Процедура Breathing education
Breathing education consists of teaching individuals to understand, control, and optimize their breathing patterns.
Первичные конечные точки
- Heart rate variability (HRV) [Срок оценки: Baseline]
- Heart rate variability (HRV) [Срок оценки: Immediately after treatment]
Вторичные конечные точки (10)
- Anthropometric variables: Weight [Срок оценки: Baseline]
- RMSSD (root mean square of successive differences) [Срок оценки: Baseline]
- SDRR (standard deviation of RR intervals) [Срок оценки: Baseline]
- Pressure pain thresholds (PPTs) [Срок оценки: Baseline]
- RMSSD (root mean square of successive differences) [Срок оценки: Immediately after treatment]
- SDRR (standard deviation of RR intervals) [Срок оценки: Immediately after treatment]
- Pressure pain thresholds (PPTs) [Срок оценки: Immediately after treatment]
- Anthropometric variables: height [Срок оценки: Baseline]
- Characteristics demographics: Age [Срок оценки: Baseline]
- Characteristics demographics: Gender [Срок оценки: Baseline]
Критерии участия
Критерии включения
- Healthy individuals who have not smoked during the 24 hours prior to the study.
- Healthy individuals who have not drunk alcohol during the 24 hours prior to the study.
- Healthy individuals who have not drunk coffee during the 24 hours prior to the study.
Критерии исключения
- Individuals with cardiovascular diseases or neurological disorders.
- Individuals with cognitive impairment.
- Individuals taking medications that affect autonomic nervous system function, such as: benzodiazepines, beta-blockers or beta-adrenergic agents.
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
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Испания · 1 центр
- University of Jaen — Jaén
Публикации
- Jafari H, Gholamrezaei A, Franssen M, Van Oudenhove L, Aziz Q, Van den Bergh O, Vlaeyen JWS, Van Diest I. Can Slow Deep Breathing Reduce Pain? An Experimental Study Exploring Mechanisms. J Pain. 2020 Sep-Oct;21(9-10):1018-1030. doi: 10.1016/j.jpain.2019.12.010. Epub 2020 Jan 22. PMID 31978501
- Gholamrezaei A, Van Diest I, Aziz Q, Pauwels A, Tack J, Vlaeyen JWS, Van Oudenhove L. Effect of slow, deep breathing on visceral pain perception and its underlying psychophysiological mechanisms. Neurogastroenterol Motil. 2022 Apr;34(4):e14242. doi: 10.1111/nmo.14242. Epub 2021 Aug 11. PMID 34378834
- Cai Y, Wang Z, Zhang W, Kong W, Jiang J, Zhao R, Wang D, Feng L, Ni G. Estimation of Heart Rate and Energy Expenditure Using a Smart Bracelet during Different Exercise Intensities: A Reliability and Validity Study. Sensors (Basel). 2022 Jun 21;22(13):4661. doi: 10.3390/s22134661. PMID 35808157
- Alabdo A, Oflazoglu B, Kus MM, Cakan P, Ugras S, Yildiz S. Cardiac Autonomic Control Reflects Sympathovagal Changes Associated With Withholding Urination. Neurourol Urodyn. 2025 Sep;44(7):1512-1520. doi: 10.1002/nau.70105. Epub 2025 Jun 27. PMID 40575945
Идентификаторы
NCT: NCT07445113 · DB and ANS