Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Deep Diaphragmatic Breathing: Neurobiological and Anti-inflammatory Effects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102813
Recruitment Status : Completed
First Posted : September 25, 2019
Last Update Posted : October 28, 2021
Sponsor:
Collaborator:
Centro Studi Psicoterapia Neo-Funzionale
Information provided by (Responsible Party):
Giuseppe Maniaci, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

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.

Condition or disease Intervention/treatment Phase
Unrecognized Condition Behavioral: Functional Therapy Not Applicable

Show Show detailed description

Layout table for study information
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
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.
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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;

Information from the National Library of Medicine

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


Locations
Layout table for location information
Italy
Unit of Psychiatry
Palermo, PA, Italy, 90100
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Centro Studi Psicoterapia Neo-Funzionale
Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giuseppe Maniaci, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo:
deep diaphragmatic breathing
cortisol
sympathetic nervous system
parasympathetic nervous system
inflammatory cytokines
Functional psychotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes