StressNCT06557083
The Effects of Daily Polyvagal Exercises on Stress in Students of Physical Therapy
A study testing Polyvagal Breathing Exercises in people with Stress and Anxiety, run by Dominican University New York at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether specific breathing exercises can stimulate the polyvagal system and thus decrease stress in healthy students of physical therapy. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Polyvagal Breathing Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2024to Dec 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Student of physical therapy
Who cannot join
- Taking medications to treat anxiety or depression
Trial locations and contacts
1 site in 1 country.
Stefanie DiCarrado, DPT contact
United States1 site, 1 recruiting
- Recruiting
Dominican University New York
Orangeburg, New York, 10962
Edeer Ayse, PhD, 845-848-7615, ayse.edeer@duny.edu
About this study
Official title: The Effects of Practicing Daily Polyvagal Exercises for Four Weeks on Stress in Students of Physical Therapy Measured: a Randomized Controlled Trial
The purpose of this study is to investigate whether specific breathing exercises can stimulate the polyvagal system and thus decrease stress in healthy students of physical therapy. The hypothesis is that practicing daily polyvagal breathing exercises will result in decreased stress/anxiety in physical therapy students compared to the control group who will not be receiving any intervention.
Read the detailed description
The study involves healthy physical therapy students of Dominican University New York (DUNY) aged 18-45 who are currently not taking anti-anxiety or anti-depression medications. The independent variable consists of practicing polyvagal breathing exercises over a 30-day period. Only the experimental/breathing group will receive treatment while the control group will not. The dependent variable, stress/anxiety labels, will be measured non-invasively using equipment such as the model number DSI-7 headset to record electroencephalogram (EEG) signals of the brain, which is commonly used in research and considered to be safe. Also, the use of surveys and questionnaires will be utilized.
The DSI-7 headset will be placed on a participant's head in order to utilize the dry sensors to record the electroencephalogram signals of the brain. This headset allows us to read the EEG signals without injecting, inserting, or applying heavy pressure to the participant's head. The participants will be seated during recording of DSI-7 and thus at minimal risk of injury.
Participants will perform three data collections: day one, day fifteen, and day thirty. Participants' brain activity will be measured six times on the day one and day thirty. The first reading, baseline EEG will be recorded while the participant is sitting in a quiet room. They will have their eyes open. The investigators will record their baselines three times for one minute and thirty seconds each. They then will be given three separate seven question timed quizzes via Kahoot in order to induce a small amount of stress. During the quizzes, EEG recordings will be collected. The participant will not receive physical harm nor long term stress. On day fifteen, four EEG recordings will be collected, one at baseline and three during the timed quizzes.
Further, all questionnaires and instructions including the breathing exercises will be given via computer. Each participant in the breathing exercise group will be provided with video instructions on the three breathing exercises and all surveys and questionnaires will be filled out using one laptop to ensure continuity for each participant. The control group will only shown a video with a brief introduction on the ill effects of stress and general tips to relieving stress. However, all participants will receive brain activity readings via EEG.
Participants will be able to withdraw from the study at any given time if they wish to, feel uncomfortable, or experience any adverse effects. The study will be conducted under the supervision of experienced researchers who will follow appropriate safety protocols to minimize any potential risks to participants.
- Being tested
- Polyvagal Breathing Exercises, No Intervention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyvagal Breathing ExercisesBehavioural
Breathing exercises provided include, square breathing, modified Qigong breathing, and three step breathing
No InterventionOther
The control group will not perform any intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control, Controlling Stress | Sham comparator | No intervention will be administered. The control participants will watch a video emphasizing the importance of stress management Receives: Other: No Intervention |
| Breathing Exercises | Experimental | The participants in the intervention group will receive a home exercise program (HEP) of Polyvagal breathing exercises. They are instructed to complete these exercises for at least five minutes per day. They are allowed to choose between the three exercises we provide. Receives: Behavioral: Polyvagal Breathing Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress Levels
Utilizing at electroencephalography at baseline, during a short stress induced task (a 7 question timed quiz, performed three times), and after the timed stress inducing task.
Q-Stats, a program to analyze the raw data, will be utilized to interpret the findings. The data is linearized. The lower the number, the more calm the individual is. (Thus, it is assumed the stress levels are decreased.
Measured: 10 minutes
Anxiety Levels
Utilizing at electroencephalography at baseline, during a short stress induced task (a 7 question timed quiz, performed three times), and after the timed stress inducing task. Q-Stats, a program to analyze the raw data, will be utilized to interpret the findings. The data is linearized. The lower the number, the more calm the individual is. (Thus, it is assumed the anxiety levels are decreased.
Measured: 10 minutes
Secondary outcomes (2)
10 Item Perceived Stress Scale
PSS-10. There are 10 questions. Each question is on a scale of 0 - 4. The scale ranges between 0 and 40. Higher scores are indicate high stress while lower scores indicate low stress.
Research tool that measures self perceived stress.
Measured: 3 minutes
7 Item Generalized Anxiety Disorder
GAD-7. There are There are 7 questions. Each question is on a scale of 0 - 3. The scale ranges between 0 and 21. Higher scores are indicate severe anxiety while lower scores indicate minimal anxiety.
Research tool that measures self perceived anxiety.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start7 Jun 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dominican University New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Miscia, Principal investigator, Dominican University New YorkElise Kang, Principal investigator, Dominican University New YorkAriane Hasbrouck, Principal investigator, Dominican University New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557083
- Sponsor's protocol ID
- DUNY
- Status last verified
- Aug 2024
- First submitted
- 25 Jun 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant information is only accessible by the principal investigators and central contacts.
Publications
Kopplin CS, Rosenthal L. The positive effects of combined breathing techniques and cold exposure on perceived stress: a randomised trial. Curr Psychol. 2022 Oct 7:1-13. doi: 10.1007/s12144-022-03739-y. Online ahead of print.
PubMed 36248220Magnon V, Dutheil F, Vallet GT. Benefits from one session of deep and slow breathing on vagal tone and anxiety in young and older adults. Sci Rep. 2021 Sep 29;11(1):19267. doi: 10.1038/s41598-021-98736-9.
PubMed 34588511Porges SW. Orienting in a defensive world: mammalian modifications of our evolutionary heritage. A Polyvagal Theory. Psychophysiology. 1995 Jul;32(4):301-18. doi: 10.1111/j.1469-8986.1995.tb01213.x.
PubMed 7652107Aranberri-Ruiz A, Aritzeta A, Olarza A, Soroa G, Mindeguia R. Reducing Anxiety and Social Stress in Primary Education: A Breath-Focused Heart Rate Variability Biofeedback Intervention. Int J Environ Res Public Health. 2022 Aug 17;19(16):10181. doi: 10.3390/ijerph191610181.
PubMed 36011817
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Practicing Daily Polyvagal Exercises for Four Weeks on Stress in Students of Physical Therapy Measured: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06557083
- Acronym / sponsor ID
- DUNY
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dominican University New YorkUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Aug 2024 (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 purpose of this study is to investigate whether specific breathing exercises can stimulate the polyvagal system and thus decrease stress in healthy students of physical therapy. The hypothesis is that practicing daily polyvagal breathing exercises will result in decreased stress/anxiety in physical therapy students compared to the control group who will not be receiving any intervention.
Detailed description
The study involves healthy physical therapy students of Dominican University New York (DUNY) aged 18-45 who are currently not taking anti-anxiety or anti-depression medications. The independent variable consists of practicing polyvagal breathing exercises over a 30-day period. Only the experimental/breathing group will receive treatment while the control group will not. The dependent variable, stress/anxiety labels, will be measured non-invasively using equipment such as the model number DSI-7 headset to record electroencephalogram (EEG) signals of the brain, which is commonly used in research and considered to be safe. Also, the use of surveys and questionnaires will be utilized.
The DSI-7 headset will be placed on a participant's head in order to utilize the dry sensors to record the electroencephalogram signals of the brain. This headset allows us to read the EEG signals without injecting, inserting, or applying heavy pressure to the participant's head. The participants will be seated during recording of DSI-7 and thus at minimal risk of injury.
Participants will perform three data collections: day one, day fifteen, and day thirty. Participants' brain activity will be measured six times on the day one and day thirty. The first reading, baseline EEG will be recorded while the participant is sitting in a quiet room. They will have their eyes open. The investigators will record their baselines three times for one minute and thirty seconds each. They then will be given three separate seven question timed quizzes via Kahoot in order to induce a small amount of stress. During the quizzes, EEG recordings will be collected. The participant will not receive physical harm nor long term stress. On day fifteen, four EEG recordings will be collected, one at baseline and three during the timed quizzes.
Further, all questionnaires and instructions including the breathing exercises will be given via computer. Each participant in the breathing exercise group will be provided with video instructions on the three breathing exercises and all surveys and questionnaires will be filled out using one laptop to ensure continuity for each participant. The control group will only shown a video with a brief introduction on the ill effects of stress and general tips to relieving stress. However, all participants will receive brain activity readings via EEG.
Participants will be able to withdraw from the study at any given time if they wish to, feel uncomfortable, or experience any adverse effects. The study will be conducted under the supervision of experienced researchers who will follow appropriate safety protocols to minimize any potential risks to participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control, Controlling Stress | Sham comparator | Other: No InterventionNo intervention will be administered. The control participants will watch a video emphasizing the importance of stress management |
| Breathing Exercises | Experimental | Behavioral: Polyvagal Breathing ExercisesThe participants in the intervention group will receive a home exercise program (HEP) of Polyvagal breathing exercises. They are instructed to complete these exercises for at least five minutes per day. They are allowed to choose between the three exercises we provide. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Student of physical therapy
Key exclusion criteria (1 listed)
- Taking medications to treat anxiety or depression
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 |
|---|---|---|
| Polyvagal Breathing ExercisesBreathing exercises provided include, square breathing, modified Qigong breathing, and three step breathing | Behavioural | Breathing Exercises |
| No InterventionThe control group will not perform any intervention. | Other | Control, Controlling Stress |
Primary outcome
Stress Levels
Time frame: 10 minutes
Utilizing at electroencephalography at baseline, during a short stress induced task (a 7 question timed quiz, performed three times), and after the timed stress inducing task. Q-Stats, a program to analyze the raw data, will be utilized to interpret the findings. The data is linearized. The lower the number, the more calm the individual is. (Thus, it is assumed the stress levels are decreased.
Anxiety Levels
Time frame: 10 minutes
Utilizing at electroencephalography at baseline, during a short stress induced task (a 7 question timed quiz, performed three times), and after the timed stress inducing task. Q-Stats, a program to analyze the raw data, will be utilized to interpret the findings. The data is linearized. The lower the number, the more calm the individual is. (Thus, it is assumed the anxiety levels are decreased.
2 secondary outcomes
10 Item Perceived Stress Scale
Time frame: 3 minutes
7 Item Generalized Anxiety Disorder
Time frame: 3 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Background: PubMed 36248220Kopplin CS, Rosenthal L. The positive effects of combined breathing techniques and cold exposure on perceived stress: a randomised trial. Curr Psychol. 2022 Oct 7:1-13. doi: 10.1007/s12144-022-03739-y. Online ahead of print.
- Background: PubMed 34588511Magnon V, Dutheil F, Vallet GT. Benefits from one session of deep and slow breathing on vagal tone and anxiety in young and older adults. Sci Rep. 2021 Sep 29;11(1):19267. doi: 10.1038/s41598-021-98736-9.
- Background: PubMed 7652107Porges SW. Orienting in a defensive world: mammalian modifications of our evolutionary heritage. A Polyvagal Theory. Psychophysiology. 1995 Jul;32(4):301-18. doi: 10.1111/j.1469-8986.1995.tb01213.x.
- Background: PubMed 36011817Aranberri-Ruiz A, Aritzeta A, Olarza A, Soroa G, Mindeguia R. Reducing Anxiety and Social Stress in Primary Education: A Breath-Focused Heart Rate Variability Biofeedback Intervention. Int J Environ Res Public Health. 2022 Aug 17;19(16):10181. doi: 10.3390/ijerph191610181.
- Individual participant dataSharing planned: No. Participant information is only accessible by the principal investigators and central contacts.
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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.
Stefanie DiCarrado, DPT contact
Kristin Miscia principal investigator
Dominican University New York
Elise Kang principal investigator
Dominican University New York
Ariane Hasbrouck principal investigator
Dominican University New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyvagal Breathing Exercises in people with Stress and Anxiety, run by Dominican University New York at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayse Edeer, PhD ((845) 848-7615, ayse.edeer@duny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress Levels (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06557083, which also lists 4 linked publications.
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 16 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.