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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04102813
Other study ID # 06/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 24, 2020
Est. completion date September 30, 2021

Study information

Verified date October 2021
Source Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Unit of Psychiatry Palermo PA

Sponsors (2)

Lead Sponsor Collaborator
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Centro Studi Psicoterapia Neo-Funzionale

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary inflammation parameters measured by saliva sample change of pro-inflammatory (IL-6, TNFa, IL1ß), and of anti-inflammatory (IL-10) cytokines measured by pg/mL. Higher levels of IL-6, TNFa, IL1ß and lower levels of IL-10 indicate an inflammation end of the treatment after the TSST (30 minutes) and 30 minutes later (follow-up)
Primary 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)
Primary 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)
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