Deep Diaphragmatic Breathing: Neurobiological and Anti-inflammatory Effects
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ClinicalTrials.gov Identifier: NCT04102813 |
Recruitment Status :
Completed
First Posted : September 25, 2019
Last Update Posted : October 28, 2021
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Condition or disease | Intervention/treatment | Phase |
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Unrecognized Condition | Behavioral: Functional Therapy | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 68 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | After a psychiatric, psychological and anthropometric assessment, healthy volunteers will receive the Trier Social Stress Test (TSST) procedure and than they are randomly assigned to 30 min of deep diagrammatic breathing based on Functional therapy (FT) or attention control (AC). All subjects are tested at the baseline (T0), at the end of the TSST (T1), at the end of the treatment (T2) and 30 minutes after the treatment (T3) |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | Subjects are advised that they are going to receive some kind of psychological support after a psychosocial stress. The investigator isn't informed about the randomisation procedures of the two groups. |
Primary Purpose: | Treatment |
Official Title: | Neurobiological and Anti-inflammatory Effects of a Deep Diaphragmatic Breathing Technique Based on Functional Psychotherapy: a Randomised Clinical Trial |
Actual Study Start Date : | February 24, 2020 |
Actual Primary Completion Date : | July 31, 2021 |
Actual Study Completion Date : | September 30, 2021 |
Arm | Intervention/treatment |
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Experimental: Functional Therapy (FT)
The FT includes a variety of functional techniques such as diaphragmatic breathing, and thoracic and abdominal manipulation, designed to stimulate the neurofunctional interconnection between body, mind and immune system. The FT session will last 30 minutes.
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Behavioral: Functional Therapy
It consists in a group of body-mind techniques based on functional theory developed in Italy by prof. Luciano Rispoli. These techniques are oriented to stimulate a diaphragmatic breathing though a thoracic and abdominal manipulation, with the aim to activate the parasympathetic nervous system and therefore reducing inflammation |
No Intervention: Attention Control (AC)
The AC group will listen an audiobook lasting for 30 minutes, which will be used as attention control activity
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- Heart rate values measured by biofeedback sensor [ Time Frame: end of the treatment after the TSST (30 minutes) and 30 minutes later (follow-up) ]change of heart rate values indicating a relaxation state (measured by blood volume pulse). Higher values of heart rate represent worst parasympathetic activity
- Skin conductance values measured by biofeedback sensor [ Time Frame: end of the treatment after the TSST (30 minutes) and 30 minutes later (follow-up) ]change of skin conductance values indicating a relaxation state (measured through micro-Siemens). Lower values of skin conductance represent worst parasympathetic activity
- Surface electromyography values measured by biofeedback sensor on left deltoid [ Time Frame: end of the treatment after the TSST (30 minutes) and 30 minutes later (follow-up) ]change of Electromyography values indicating a relaxation state (measured through microvolts). Higher values of skin conductance represent worst parasympathetic activity
- cortisol levels measured by saliva sample [ Time Frame: end of the treatment after the TSST (30 minutes) and 30 minutes later (follow-up) ]change of cortisol levels measured by ng/ml. Higher values indicate worst stress levels
- inflammation parameters measured by saliva sample [ Time Frame: end of the treatment after the TSST (30 minutes) and 30 minutes later (follow-up) ]change of pro-inflammatory (IL-6, TNFα, IL1β), and of anti-inflammatory (IL-10) cytokines measured by pg/mL. Higher levels of IL-6, TNFα, IL1β and lower levels of IL-10 indicate an inflammation
- state anxiety measured by State Trait Anxiety Inventory [ Time Frame: end of the treatment after the TSST (30 minutes) and 30 minutes later (follow-up) ]change of state anxiety (measured by State Trait Anxiety Inventory questionnaire). The score is from 20 to 80. Higher values indicate a worst state anxiety
- perceived stress measured by Subjective Units of Distress Scale [ Time Frame: end of the treatment after the TSST (30 minutes) and 30 minutes later (follow-up) ]change of perceived stress (measured by Subjective Units of Distress Scale questionnaire).The score is from 0 to 10. Higher values indicate a worst perceived stress

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Men and women aging between 18 and 55;
- Able to understanding and signing the informed consent;
Exclusion Criteria:
- a current or lifetime diagnosis of any psychiatric disorders
- a past or present of drug abuse or drug addiction (including nicotine)
- chronic inflammation diseases
- Taking medicines active on the immune system (antibiotics, anti-histamines, corticosteroids, psychotropic substances) during the 2 weeks prior to the operation;
- Intense physical activities (at least 1h\day);
- Intelligence Quotient less than 65
- BMI more than 40
- serious infections (such as HIV, hepatitis B and C)
- cancer in the previous 6 months
- regular use of anti-inflammatory drugs for more than 15 days/month
- Participation to other clinical trials;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102813
Italy | |
Unit of Psychiatry | |
Palermo, PA, Italy, 90100 |
Responsible Party: | Giuseppe Maniaci, Adjunct Professor, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo |
ClinicalTrials.gov Identifier: | NCT04102813 |
Other Study ID Numbers: |
06/2019 |
First Posted: | September 25, 2019 Key Record Dates |
Last Update Posted: | October 28, 2021 |
Last Verified: | October 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
deep diaphragmatic breathing cortisol sympathetic nervous system |
parasympathetic nervous system inflammatory cytokines Functional psychotherapy |
Respiratory Aspiration Respiration Disorders Respiratory Tract Diseases Pathologic Processes |