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Идёт набор NCT06557083

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

Без фазы С лечением Stress Anxiety

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Polyvagal Breathing Exercises, No Intervention.
Кому может быть актуально
Состояния в реестре: Stress, Anxiety. Базовые параметры: 18 лет — 45 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Polyvagal Breathing Exercises
    Breathing exercises provided include, square breathing, modified Qigong breathing, and three step breathing
  • Другое No Intervention
    The control group will not perform any intervention.

Первичные конечные точки

  • Stress Levels [Срок оценки: 10 minutes]
  • Anxiety Levels [Срок оценки: 10 minutes]
Вторичные конечные точки (2)
  • 10 Item Perceived Stress Scale [Срок оценки: 3 minutes]
  • 7 Item Generalized Anxiety Disorder [Срок оценки: 3 minutes]

Критерии участия

Критерии включения

  • Student of physical therapy

Критерии исключения

  • Taking medications to treat anxiety or depression

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Dominican University New York — Orangeburg

Публикации

  • 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
  • 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
  • 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
  • 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

Идентификаторы

NCT: NCT06557083 · DUNY

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗