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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group 1. SDB 6x 6 | Experimental | Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E) ratio of 1:1 |
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| Experimental Group 2. SDB 6x6x6 | Experimental | Guided breathing at 6 bpm with apnea (A) and an I:E:A ratio of 1:1:1. |
|
| Control Group | Placebo Comparator | Breathing education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability (HRV) | Heart rate variability (HRV): measured using the Polar H10 heart rate sensor. | Baseline |
| Heart rate variability (HRV) | Heart rate variability (HRV): measured using the Polar H10 heart rate sensor | Immediately after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric variables: Weight | Weight was measured using a calibrated digital scale | Baseline |
| RMSSD (root mean square of successive differences) | RMSSD (root mean square of successive differences) measured using the validated Elite HRV application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Sedeño Vidal, Full time professor | Contact | 34 654428130 | asedeno@ujaen.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Jaen | Jaén | Jaén | 23071 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31978501 | Background | 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. | |
| 34378834 | Background | 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. |
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The data of the study will be available under reasonable request to the corresponding author or published in the Repository of the university of Jaen (www.ruja.es)
From the publication of the manuscript about the study report until with no end date.
Any request by email will be attended, as well as everybody could access to RUJA repository as it is public. For access, people will have to request by email or access to www.ruja.es
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|
|
| Guided breathing at 6 bpm with apnea (A) | Procedure | 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. |
|
|
| Breathing education | Procedure | Breathing education consists of teaching individuals to understand, control, and optimize their breathing patterns. |
|
|
| Baseline |
| SDRR (standard deviation of RR intervals) | SDRR (standard deviation of RR intervals): assessed using the validated Elite HRV application. | Baseline |
| Pressure pain thresholds (PPTs) | Pressure pain sensitivity was evaluated using a digital algometer (FPIX; Wagner Instruments, Greenwich, CT, EE.UU). PPTs were measured at the spinous process of C3-C4. | Baseline |
| RMSSD (root mean square of successive differences) | RMSSD (root mean square of successive differences) measured using the validated Elite HRV application | Immediately after treatment |
| SDRR (standard deviation of RR intervals) | SDRR (standard deviation of RR intervals) assessed using the validated Elite HRV application | Immediately after treatment |
| Pressure pain thresholds (PPTs) | Pressure pain sensitivity was evaluated using a digital algometer (FPIX; Wagner Instruments, Greenwich, CT, EE.UU). PPTs were measured at the spinous process of C3-C4 | Immediately after treatment |
| Anthropometric variables: height | Height was measured with a calibrated stadiometer | Baseline |
| Characteristics demographics: Age | Age was self-reported by the participants | Baseline |
| Characteristics demographics: Gender | Gender was self-reported by the participants | Baseline |
| 35808157 | Background | 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. |
| 40575945 | Background | 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. |
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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