Neofunctional Deep Breathing for Stress Modulation

NCT07023211 | Completed

• 1 other identifier: AOPalermo_2
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot randomized clinical trial is to learn if a single session of Neo-Functional diaphragmatic breathing can stimulate vagotonia and help to restore a state of relaxation after acute stress in healthy adult volunteers (male and female, aged 18-45). The main research question is: does a single 30-minute session of Neo-Functional diaphragmatic breathing intervention lead to better physiological (heart rate, skin conductance, muscle tension, abdominal excursion) and psychological (State-Trait Anxiety Inventory - State scale \[STAI-State\], Subjective Units of Distress Scale \[SUDS\]) recovery after an acute stressor (Trier Social Stress Test \[TSST\]) compared to a control condition? The study will compare an experimental group receiving the Neo-Functional diaphragmatic breathing intervention to a control group that rests in the presence of a therapist with minimal contact but without the specific breathing technique, to see if the breathing intervention results in a more significant reduction in stress markers and improvement in relaxation indicators. Participants will: undergo initial assessments including physiological measurements (heart rate \[HR\], skin conductance \[SC\], left deltoid surface electromyography \[EMG\], respiratory rate \[breaths per minute, BPM\] and respiratory amplitude \[RESP AMP\], derived from abdominal excursion), anthropometric measurements (weight, height, Body Mass Index \[BMI\]), and psychological questionnaires (STAI-State, SUDS); be subjected to the Trier Social Stress Test (TSST) to induce acute stress; undergo post-stress assessments (physiological and psychological); be randomly assigned to either receive a 30-minute Neo-Functional diaphragmatic breathing session (Experimental Group) or rest in the presence of a therapist (Control Group); undergo final physiological and psychological assessments.

Conditions

Healthy

Keywords

diaphragmatic breathing; mind-body therapies; stress; vagal tone; social touch; Functional psychotherapy; parasympathetic nervous system

Outcome Measures

Primary Outcomes (7)

• Changes in heart rate values

  The difference in mean HR is an indirect measure of autonomous nervous system. It will be measured non-invasively via ProComp Infiniti photoplethysmograph. Higher values of HR represent worst parasympathetic activity.

  Immediately Post-TSST (T1) and immediately post-intervention (T2)

• Changes in skin conductance values

  Changes in mean SC values, measured non-invasively in micro-Siemens (µS) using the ProComp Infiniti physiological measurement unit. Higher SC values reflect greater physiological arousal, indicating increased sympathetic nervous system activity.

  Immediately Post-TSST (T1) and immediately post-intervention (T2)

• Changes in surface electromyography values on left deltoid

  Changes of mean EMG values, measured non-invasively in microvolts (µV) using using the ProComp Infiniti physiological measurement unit. Higher mean EMG values indicate greater muscle tension, and suggest sympathetic activation.

  Immediately Post-TSST (T1) and immediately post-intervention (T2)

• Changes in state anxiety

  Changes in state anxiety, measured by the STAI-state questionnaire. The score range from 20 to 80, with higher values indicating worst levels of anxiety.

  Immediately Post-TSST (T1) and immediately post-intervention (T2)

• Changes in perceived stress

  Changes in perceived stress measured by the SUDS questionnaire. The score ranging from 0 to 10, with higher values indicating worst levels of perceived stress.

  Immediately Post-TSST (T1) and immediately post-intervention (T2)

• Changes in respiratory amplitude

  Changes in RESP AMP were measured non-invasively using an abdominal elastic band connected to the ProComp Infiniti physiological measurement unit. The system quantifies the extent of abdominal expansion and contraction during each breath cycle, providing a measure of the depth of breathing. Higher abdominal amplitude indicate a deeper, more diaphragmatic breathing.

  Immediately Post-TSST (T1) and immediately post-intervention (T2)

• Changes in respiratory rate

  Changes in respiratory rate were measured using an abdominal elastic band connected to the ProComp Infiniti physiological measurement unit. The system detects the cyclical expansion and contraction of the abdomen to determine the number of BPM. A lower respiratory rate is indicative of a shift towards a more relaxed breathing pattern.

  Immediately Post-TSST (T1) and immediately post-intervention (T2)

Study Arms (2)

Functional Therapy (FT)

EXPERIMENTAL

Participants will be lying down in supine position. This breathing technique, rooted in the Neo-Functionalist orientation which actively utilizes body contact, involves direct manual assistance from the therapist during different respiratory movements. It is specifically aimed at promoting and facilitating congruent movements across the thoracic, diaphragmatic, and abdominal regions throughout the breathing cycle, enhancing the targeted respiratory pattern. The intervention will be delivered by a psychotherapist specialized in Neo-Functional techniques. Selected musical tracks accompany the session. The FT session will last 30 minutes.

Behavioral: Neo-Functional diaphragmatic breathing

Social Touch (ST)

SHAM COMPARATOR

This group is designed to control for the variable of physical contact. Participants will receive occasional physical contact applied by the therapist specifically to the participant's right arm, while listening to the same musical tracks used in the experimental (FT) group. This contact is deliberately non-specific to the breathing process and contrasts with the targeted manual respiratory assistance provided to the experimental group. Participants in this group will not receive breathing instructions. The ST session will last 30 minutes.

Behavioral: Social touch

Interventions

Neo-Functional diaphragmatic breathing BEHAVIORAL

This technique, rooted in the Neo-Functionalist orientation which actively utilizes body contact, involves direct manual assistance from the therapist during different respiratory movements. This hands-on guidance is specifically aimed at promoting and facilitating congruent movements across the thoracic, diaphragmatic, and abdominal regions throughout the breathing cycle, enhancing the targeted respiratory pattern. The intervention will be delivered by a psychotherapist specialized in Neo-Functional techniques.

Functional Therapy (FT)

Social touch BEHAVIORAL

Participants will receive occasional physical contact applied by the therapist specifically to the right arm. This contact is deliberately non-specific to the breathing process and contrasts with the targeted manual respiratory assistance provided to the experimental group. Participants in this group will not receive breathing instructions.

Social Touch (ST)

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 of Policlinico P. Giaccone

Palermo, Italy, 90100, Italy

Location

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 then they are randomly assigned to 30 min of deep diaphragmatic breathing based on Functional Therapy (FT) or Social Touch (ST). All subjects are tested at the baseline (T0), at the end of the TSST (T1), and at the end of the treatment (T2).

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 15, 2025
• Study Start: June 30, 2025
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

IT (1)