Deep Diaphragmatic Breathing: Neurobiological and Anti-inflammatory Effects

NCT04102813 | Completed

• 1 other identifier: 06/2019
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The exposure to acute and\\or chronic stress can produce an activation of sympathetic nervous system (SNS), leading to an increased level of cortisol and pro-inflammatory cytokines. The mind-body techniques (MBT), such as diaphragmatic breathing, mindfulness, and Yoga, have demonstrated their validity in reducing mental stress and relieving inflammatory conditions. The aim of our study is to verify the efficacy of a single Functional Therapy (FT) session to relieve inflammations, decreasing cortisol levels and activating the parasympathetic nervous system in healthy subjects after the administration of an acute stress such as the Trier Social Stress Test (TSST) protocol. After a psychiatric, psychological and anthropometric assessment, participants are randomly assigned to FT or attention placebo control group. The FT session lasting for 30 minutes and is conducted by therapists specialized in the MBT. The treatment's efficacy in reducing inflammatory states is verified by measuring the variations of the hearth rate, skin conductance, electromyography, pro-inflammatory cytokines (IL-6, TNFα, IL1β), anti-inflammatory cytokine (IL-10), and salivary cortisol; furthermore, the State Trait Anxiety Inventory (STAI) (state and trait) and Subjective Units of Distress Scale (SUDS) questionnaires are used as psychometric measures of anxiety and stress. All the participants are tested at baseline, at the end of TSST, at the end of the FT or audiobook session, and at follow-up 30 minutes after the session.

Conditions

Unrecognized Condition

Keywords

deep diaphragmatic breathing; cortisol; sympathetic nervous system; parasympathetic nervous system; inflammatory cytokines; Functional psychotherapy

Outcome Measures

Primary Outcomes (7)

• Heart rate values measured by biofeedback sensor

  change of heart rate values indicating a relaxation state (measured by blood volume pulse). Higher values of heart rate represent worst parasympathetic activity

  end of the treatment after the TSST (30 minutes) and 30 minutes later (follow-up)

• Skin conductance values measured by biofeedback sensor

  change of skin conductance values indicating a relaxation state (measured through micro-Siemens). Lower values of skin conductance represent worst parasympathetic activity

  end of the treatment after the TSST (30 minutes) and 30 minutes later (follow-up)

• Surface electromyography values measured by biofeedback sensor on left deltoid

  change of Electromyography values indicating a relaxation state (measured through microvolts). Higher values of skin conductance represent worst parasympathetic activity

  end of the treatment after the TSST (30 minutes) and 30 minutes later (follow-up)

• cortisol levels measured by saliva sample

  change of cortisol levels measured by ng/ml. Higher values indicate worst stress levels

  end of the treatment after the TSST (30 minutes) and 30 minutes later (follow-up)

• inflammation parameters measured by saliva sample

  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

  end of the treatment after the TSST (30 minutes) and 30 minutes later (follow-up)

• state anxiety measured by State Trait Anxiety Inventory

  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

  end of the treatment after the TSST (30 minutes) and 30 minutes later (follow-up)

• perceived stress measured by Subjective Units of Distress Scale

  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

  end of the treatment after the TSST (30 minutes) and 30 minutes later (follow-up)

Study Arms (2)

Functional Therapy (FT)

EXPERIMENTAL

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.

Behavioral: Functional Therapy

Attention Control (AC)

NO INTERVENTION

The AC group will listen an audiobook lasting for 30 minutes, which will be used as attention control activity

Interventions

Functional Therapy BEHAVIORAL

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

Functional Therapy (FT)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aging between 18 and 55;
• Able to understanding and signing the informed consent;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo: lead
• Centro Studi Psicoterapia Neo-Funzionale: collaborator

Study Sites (1)

Unit of Psychiatry

Palermo, PA, 90100, Italy

Location

Related Publications (1)

• Maniaci G, Daino M, Iapichino M, Giammanco A, Taormina C, Bonura G, Sardella Z, Carolla G, Cammareri P, Sberna E, Clesi MF, Ferraro L, Gambino CM, Ciaccio M, Rispoli L, La Cascia C, La Barbera D, Quattrone D. Neurobiological and Anti-Inflammatory Effects of a Deep Diaphragmatic Breathing Technique Based on Neofunctional Psychotherapy: A Pilot RCT. Stress Health. 2024 Dec;40(6):e3503. doi: 10.1002/smi.3503. Epub 2024 Nov 14.

  PMID: 39543797 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Model Details: 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)

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 25, 2019
• Study Start: February 24, 2020
• Primary Completion: July 31, 2021
• Study Completion: September 30, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

IT (1)