Neofunctional Deep Breathing for Stress Modulation

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

Interventions

BEHAVIORAL

Neo-Functional diaphragmatic breathing

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.

BEHAVIORAL

Social touch

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.

Sponsors & Collaborators

• Centro Studi Psicoterapia Neo-Funzionale

  collaborator UNKNOWN

• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-06-30

Primary Completion

2025-07-30

Completion

2025-07-30

Countries

• Italy

Study Locations