HealthySIREDNCT07023211
Neofunctional Deep Breathing for Stress Modulation
A study testing Neo-Functional diaphragmatic breathing and Social touch in people with Healthy, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Neo-Functional diaphragmatic breathing and Social touch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2025to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aging between 18 and 55;
- Able to understanding and signing the informed consent;
Who cannot join
- 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
Show all 11Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neofunctional Deep Diaphragmatic Breathing Interventions for Stress Modulation: A Comparative RCT Assessing Physiological and Psychological Parameters
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.
Read the detailed description
Modern life often exposes individuals to significant levels of stress, which can negatively impact both psychological well-being and physical health. Chronic stress is known to disrupt the body's natural balance, potentially affecting the immune system and contributing to various health problems. This interplay between the mind, nervous system, endocrine system, and immune system is studied within the field of Psycho-Neuro-Endocrino-Immunology (PNEI). Mind-Body Therapies (MBTs), such as Yoga, Mindfulness, and Qigong, often incorporate specific breathing techniques, particularly diaphragmatic breathing (deep, abdominal breathing), as a core component. These techniques are thought to exert their beneficial effects, at least in part, by stimulating the vagus nerve. The vagus nerve is a major component of the parasympathetic nervous system, often referred to as the "rest and digest" system, which counteracts the stress response ("fight or flight") driven by the sympathetic nervous system. Enhanced vagal tone is associated with better stress regulation, reduced inflammation, and improved overall health. This study focuses on a specific diaphragmatic breathing technique derived from the Neo-Functionalism theoretical orientation. This approach suggests that therapeutic interventions targeting bodily functions can influence psychological states. Uniquely, the Neo-Functional technique, as applied in this study, involves not only guided breathing instruction but also direct physical contact and specific breathing maneuvers. While the long-term benefits of various MBTs are increasingly documented, there is limited research, particularly using rigorous, controlled designs, investigating the immediate physiological and psychological effects of a single session of a specific, guided diaphragmatic breathing technique involving manual assistance following an acute stress exposure. Healthy volunteers will be recruited via advertisements. It is planned to enroll a sample of 40 participants (aged 18-45 years, balanced for sex). For initial screening, interested subjects will be evaluated by a psychologist or psychiatry resident using a structured diagnostic interview (Structured Clinical Interview for DSM-5 [SCID-5]) to exclude the presence of psychiatric disorders. All study assessments and procedures will take place at the premises of the Section of Psychiatry, Department of Biomedicine, Neurosciences and Advanced Diagnostics, at the "P. Giaccone" Polyclinic in Palermo. Following the initial assessment and confirmation of eligibility, subjects will be randomized to either the Experimental group or the Control group. All experimental sessions will occur in a controlled setting within the Section of Psychiatry. During the session, anthropometric, psychological, and physiological parameters via biofeedback will be assessed for each participant. Anthropometric parameters include height, weight, and Body Mass Index (BMI). Psychological assessment includes the State-Trait Anxiety Inventory (limited to the State scale - STAI-State) and the Subjective Units of Distress Scale (SUDS). Biofeedback parameters include 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, with biofeedback sensors remaining connected throughout the experimental procedure. Upon arrival (T0 - Baseline), anthropometric parameters will be assessed, then biofeedback sensors will be applied, and physiological parameters will be recorded at rest to establish the baseline; STAI-State and SUDS questionnaires will also be administered at this time. Subsequently, participants will undergo the Trier Social Stress Test (TSST), a standardized protocol used to induce psychophysiological stress under controlled conditions. The TSST is divided into 5-minute components and the whole procedure lasts approximately 15 minutes. At the end of the TSST (T1 - Post-Stress), physiological parameters via biofeedback will be measured again, and the STAI-State and SUDS questionnaires will be re-administered to assess the stress response. Immediately following this, participants will receive the intervention assigned by randomization for a duration of 30 minutes: the Experimental group will receive a diaphragmatic breathing intervention according to the Neo-Functional approach, conducted by specialized psychotherapists, involving active manual assistance to facilitate congruent respiratory movements; the Control group will rest in the same room in the presence of a therapist who, to control for the potential vagotonic effects of physical contact, will apply occasional non-specific physical contact to the participant's arm without providing breathing instructions or applying the specific diaphragmatic technique. At the end of the 30-minute intervention or control period (T2 - Post-Intervention), physiological parameters via biofeedback will be measured once more, and the STAI-State and SUDS questionnaires will be re-administered to evaluate stress recovery.
This research aims to provide initial evidence on the efficacy of a single session of Neo-Functional diaphragmatic breathing for acute stress recovery. Understanding the immediate neurobiological and psychological effects can inform the use of such techniques as accessible tools for stress management in daily life or during periods of tension. By including a control group matched for physical contact, the study aims to differentiate the specific benefits of the targeted breathing technique involving manual guidance from the more general effects of therapeutic presence and touch. The findings may contribute to the broader understanding of how targeted breathing practices influence the autonomic nervous system and subjective well-being. The psychoeducational component may also indirectly benefit participants by increasing their awareness of stress effects and potential coping strategies.
- Conditions
- Healthy
- Being tested
- Neo-Functional diaphragmatic breathing, Social touch
- Keywords
- diaphragmatic breathing, mind-body therapies, stress, vagal tone, social touch, Functional psychotherapy, parasympathetic nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neo-Functional diaphragmatic breathingBehavioural
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.
Social touchBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Social touch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately Post-TSST (T1) and immediately post-intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start30 Jun 2025
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Studi Psicoterapia Neo-Funzionale
- Responsible party
- Principal investigator, Giuseppe Maniaci, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023211
- Sponsor's protocol ID
- AOPalermo_2
- Acronym
- SIRED
- Status last verified
- Aug 2025
- First submitted
- 26 May 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neofunctional Deep Diaphragmatic Breathing Interventions for Stress Modulation: A Comparative RCT Assessing Physiological and Psychological Parameters
- ClinicalTrials.gov ID
- NCT07023211
- Acronym / sponsor ID
- SIRED / AOPalermo_2
- Conditions
- Healthy
- Keywords
- diaphragmatic breathing, mind-body therapies, stress, vagal tone, social touch, Functional psychotherapy, parasympathetic nervous system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone PalermoUniversity, hospital or other
- Collaborators
- Centro Studi Psicoterapia Neo-Funzionale
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Modern life often exposes individuals to significant levels of stress, which can negatively impact both psychological well-being and physical health. Chronic stress is known to disrupt the body's natural balance, potentially affecting the immune system and contributing to various health problems. This interplay between the mind, nervous system, endocrine system, and immune system is studied within the field of Psycho-Neuro-Endocrino-Immunology (PNEI). Mind-Body Therapies (MBTs), such as Yoga, Mindfulness, and Qigong, often incorporate specific breathing techniques, particularly diaphragmatic breathing (deep, abdominal breathing), as a core component. These techniques are thought to exert their beneficial effects, at least in part, by stimulating the vagus nerve. The vagus nerve is a major component of the parasympathetic nervous system, often referred to as the "rest and digest" system, which counteracts the stress response ("fight or flight") driven by the sympathetic nervous system. Enhanced vagal tone is associated with better stress regulation, reduced inflammation, and improved overall health. This study focuses on a specific diaphragmatic breathing technique derived from the Neo-Functionalism theoretical orientation. This approach suggests that therapeutic interventions targeting bodily functions can influence psychological states. Uniquely, the Neo-Functional technique, as applied in this study, involves not only guided breathing instruction but also direct physical contact and specific breathing maneuvers. While the long-term benefits of various MBTs are increasingly documented, there is limited research, particularly using rigorous, controlled designs, investigating the immediate physiological and psychological effects of a single session of a specific, guided diaphragmatic breathing technique involving manual assistance following an acute stress exposure. Healthy volunteers will be recruited via advertisements. It is planned to enroll a sample of 40 participants (aged 18-45 years, balanced for sex). For initial screening, interested subjects will be evaluated by a psychologist or psychiatry resident using a structured diagnostic interview (Structured Clinical Interview for DSM-5 [SCID-5]) to exclude the presence of psychiatric disorders. All study assessments and procedures will take place at the premises of the Section of Psychiatry, Department of Biomedicine, Neurosciences and Advanced Diagnostics, at the "P. Giaccone" Polyclinic in Palermo. Following the initial assessment and confirmation of eligibility, subjects will be randomized to either the Experimental group or the Control group. All experimental sessions will occur in a controlled setting within the Section of Psychiatry. During the session, anthropometric, psychological, and physiological parameters via biofeedback will be assessed for each participant. Anthropometric parameters include height, weight, and Body Mass Index (BMI). Psychological assessment includes the State-Trait Anxiety Inventory (limited to the State scale - STAI-State) and the Subjective Units of Distress Scale (SUDS). Biofeedback parameters include 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, with biofeedback sensors remaining connected throughout the experimental procedure. Upon arrival (T0 - Baseline), anthropometric parameters will be assessed, then biofeedback sensors will be applied, and physiological parameters will be recorded at rest to establish the baseline; STAI-State and SUDS questionnaires will also be administered at this time. Subsequently, participants will undergo the Trier Social Stress Test (TSST), a standardized protocol used to induce psychophysiological stress under controlled conditions. The TSST is divided into 5-minute components and the whole procedure lasts approximately 15 minutes. At the end of the TSST (T1 - Post-Stress), physiological parameters via biofeedback will be measured again, and the STAI-State and SUDS questionnaires will be re-administered to assess the stress response. Immediately following this, participants will receive the intervention assigned by randomization for a duration of 30 minutes: the Experimental group will receive a diaphragmatic breathing intervention according to the Neo-Functional approach, conducted by specialized psychotherapists, involving active manual assistance to facilitate congruent respiratory movements; the Control group will rest in the same room in the presence of a therapist who, to control for the potential vagotonic effects of physical contact, will apply occasional non-specific physical contact to the participant's arm without providing breathing instructions or applying the specific diaphragmatic technique. At the end of the 30-minute intervention or control period (T2 - Post-Intervention), physiological parameters via biofeedback will be measured once more, and the STAI-State and SUDS questionnaires will be re-administered to evaluate stress recovery.
This research aims to provide initial evidence on the efficacy of a single session of Neo-Functional diaphragmatic breathing for acute stress recovery. Understanding the immediate neurobiological and psychological effects can inform the use of such techniques as accessible tools for stress management in daily life or during periods of tension. By including a control group matched for physical contact, the study aims to differentiate the specific benefits of the targeted breathing technique involving manual guidance from the more general effects of therapeutic presence and touch. The findings may contribute to the broader understanding of how targeted breathing practices influence the autonomic nervous system and subjective well-being. The psychoeducational component may also indirectly benefit participants by increasing their awareness of stress effects and potential coping strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Functional Therapy (FT) | Experimental | Behavioral: Neo-Functional diaphragmatic breathingParticipants 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. |
| Social Touch (ST) | Sham comparator | Behavioral: Social touchThis 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and women aging between 18 and 55;
- Able to understanding and signing the informed consent;
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neo-Functional diaphragmatic breathingThis 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. | Behavioural | Functional Therapy (FT) |
| Social touchParticipants 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. | Behavioural | Social Touch (ST) |
Primary outcome
Changes in heart rate values
Time frame: Immediately Post-TSST (T1) and immediately post-intervention (T2)
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.
Changes in skin conductance values
Time frame: Immediately Post-TSST (T1) and immediately post-intervention (T2)
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.
Changes in surface electromyography values on left deltoid
Time frame: Immediately Post-TSST (T1) and immediately post-intervention (T2)
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.
Changes in state anxiety
Time frame: Immediately Post-TSST (T1) and immediately post-intervention (T2)
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.
Changes in perceived stress
Time frame: Immediately Post-TSST (T1) and immediately post-intervention (T2)
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.
Changes in respiratory amplitude
Time frame: Immediately Post-TSST (T1) and immediately post-intervention (T2)
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.
Changes in respiratory rate
Time frame: Immediately Post-TSST (T1) and immediately post-intervention (T2)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neo-Functional diaphragmatic breathing and Social touch in people with Healthy, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in heart rate values (time frame: Immediately Post-TSST (T1) and immediately post-intervention (T2)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.