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

NCT ID: NCT06557083

Last Updated: 2024-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-07

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Stress Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control, Controlling Stress

No intervention will be administered. The control participants will watch a video emphasizing the importance of stress management

Group Type SHAM_COMPARATOR

No Intervention

Intervention Type OTHER

The control group will not perform any intervention.

Breathing Exercises

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.

Group Type EXPERIMENTAL

Polyvagal Breathing Exercises

Intervention Type BEHAVIORAL

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

Interventions

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Polyvagal Breathing Exercises

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

Intervention Type BEHAVIORAL

No Intervention

The control group will not perform any intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Student of physical therapy

Exclusion Criteria

* Taking medications to treat anxiety or depression
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dominican University New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristin Miscia

Role: PRINCIPAL_INVESTIGATOR

Dominican University New York

Elise Kang

Role: PRINCIPAL_INVESTIGATOR

Dominican University New York

Ariane Hasbrouck

Role: PRINCIPAL_INVESTIGATOR

Dominican University New York

Locations

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Dominican University New York

Orangeburg, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ayse Edeer, PhD

Role: CONTACT

(845) 848-7615

Stefanie DiCarrado, DPT

Role: CONTACT

Facility Contacts

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Edeer Ayse, PhD

Role: primary

845-848-7615

References

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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.

Reference Type BACKGROUND
PMID: 36248220 (View on PubMed)

Magnon 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.

Reference Type BACKGROUND
PMID: 34588511 (View on PubMed)

Porges 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.

Reference Type BACKGROUND
PMID: 7652107 (View on PubMed)

Aranberri-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.

Reference Type BACKGROUND
PMID: 36011817 (View on PubMed)

Other Identifiers

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DUNY

Identifier Type: -

Identifier Source: org_study_id

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