Diaphragmatic Breathing and Stimulation of the Autonomic Nervous System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Healthy Adult Male and Female Volunteers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Influence of Diaphragmatic Breathing Through Slow, Deep Respiration on Vagal Nerve Modulation and Stimulation of the Autonomic Nervous System
Overview
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.
Interventions
- Procedure 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. - Procedure 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. - Procedure Breathing education
Breathing education consists of teaching individuals to understand, control, and optimize their breathing patterns.
Primary outcome measures
- Heart rate variability (HRV) [Time frame: Baseline]
- Heart rate variability (HRV) [Time frame: Immediately after treatment]
Secondary outcome measures (10)
- Anthropometric variables: Weight [Time frame: Baseline]
- RMSSD (root mean square of successive differences) [Time frame: Baseline]
- SDRR (standard deviation of RR intervals) [Time frame: Baseline]
- Pressure pain thresholds (PPTs) [Time frame: Baseline]
- RMSSD (root mean square of successive differences) [Time frame: Immediately after treatment]
- SDRR (standard deviation of RR intervals) [Time frame: Immediately after treatment]
- Pressure pain thresholds (PPTs) [Time frame: Immediately after treatment]
- Anthropometric variables: height [Time frame: Baseline]
- Characteristics demographics: Age [Time frame: Baseline]
- Characteristics demographics: Gender [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- University of Jaen — Jaén
Publications
- 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
Identifiers
NCT: NCT07445113 · DB and ANS