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

NCT06557083 | Recruiting

• 1 other identifier: DUNY
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stress; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  10 minutes

Secondary Outcomes (2)

• 10 Item Perceived Stress Scale

  3 minutes

• 7 Item Generalized Anxiety Disorder

  3 minutes

Study Arms (2)

Control, Controlling Stress

SHAM COMPARATOR

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

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.

Behavioral: Polyvagal Breathing Exercises

Interventions

Polyvagal Breathing Exercises BEHAVIORAL

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

Breathing Exercises

No Intervention OTHER

The control group will not perform any intervention.

Control, Controlling Stress

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Student of physical therapy

You may not qualify if:

• Taking medications to treat anxiety or depression

Sponsors & Collaborators

• Dominican University New York: lead

Study Sites (1)

Dominican University New York

Orangeburg, New York, 10962, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 36248220 BACKGROUND

• 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.

  PMID: 34588511 BACKGROUND

• 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.

  PMID: 7652107 BACKGROUND

• 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.

  PMID: 36011817 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Kristin Miscia

  Dominican University New York

  PRINCIPAL INVESTIGATOR

• Elise Kang

  Dominican University New York

  PRINCIPAL INVESTIGATOR

• Ariane Hasbrouck

  Dominican University New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayse Edeer, PhD

CONTACT

(845) 848-7615; ayse.edeer@duny.edu

Stefanie DiCarrado, DPT

CONTACT

stefanie.dicarrado@duny.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: August 16, 2024
• Study Start: June 7, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)