Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557083
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-25
Brief Title:
The Effects of Daily Polyvagal Exercises on Stress in Students of Physical Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effects of Practicing Daily Polyvagal Exercises for Four Weeks on Stress in Students of Physical Therapy Measured a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 stressanxiety 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 experimentalbreathing group will receive treatment while the control group will not The dependent variable stressanxiety 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 participants 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 participants 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
The DSI-7 headset will be placed on a participants 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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None