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NCT Number: NCT06557083

The Effects of Daily Polyvagal Exercises on Stress in Students of Physical Therapy

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dominican University New York

Orangeburg, New York, 10962, United States

Location status: Recruiting

Location contact

Edeer Ayse, PhD

CONTACT

[email protected]

845-848-7615

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Student of physical therapy

Exclusion criteria

  • Taking medications to treat anxiety or depression

Treatment and study plan

Polyvagal Breathing Exercises

Behavioral

Breathing exercises provided include, square breathing, modified Qigong breathing, and three step breathing

No intervention

Other

The control group will not perform any intervention.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 10 Item Perceived Stress Scale

    Time frame: 3 minutes

    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.

  2. 7 Item Generalized Anxiety Disorder

    Time frame: 3 minutes

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayse Edeer, PhD

CONTACT

[email protected]

(845) 848-7615

Stefanie DiCarrado, DPT

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Dominican University New York

Other

Registry information

Official study title

The Effects of Practicing Daily Polyvagal Exercises for Four Weeks on Stress in Students of Physical Therapy Measured: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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