- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07472010
Mandibular Stretching and 4-4-8 Breathing Exercises on Autonomic Nervous System Activity (MSE-BR)
Investigation of the Effects of Mandibular Stretching Exercise and 4-4-8 Breathing Exercise on Autonomic Nervous System Activity, Muscle Tone, and Psychological State: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
The autonomic nervous system plays an important role in regulating physiological and psychological responses. Breathing techniques and mandibular stretching exercises are non-invasive approaches that may influence autonomic nervous system activity and muscle tone through neuromuscular and respiratory mechanisms. However, the combined or individual effects of these interventions on autonomic regulation and psychological outcomes remain insufficiently investigated.
This randomized controlled trial aims to examine the effects of mandibular stretching exercise and the 4-4-8 breathing exercise on autonomic nervous system activity, muscle tone, and psychological state in healthy university students. Participants will be randomly allocated to intervention groups according to the study protocol. Baseline and post-intervention measurements will be collected to evaluate changes in autonomic nervous system parameters, muscle tone, and psychological status.
The findings of this study may contribute to understanding the potential benefits of simple non-pharmacological interventions such as mandibular stretching and breathing exercises in improving physiological regulation and psychological well-being.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mehin Mammadzada, MSc Student
- Phone Number: +905313124790
- Email: mammadzadamehin01@gmail.com
Study Locations
-
-
Konya
-
Konya, Konya, Turkey (Türkiye)
- Recruiting
- Necmettin Erbakan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Inclusion Criteria:
- Healthy university students
- Age between 18 and 30 years
- Voluntary participation in the study
- Ability to understand and perform mandibular stretching exercise and 4-4-8 breathing exercise
Exclusion Criteria:
- History of neurological disorders
- Musculoskeletal disorders affecting the jaw, neck, or respiratory system
- Respiratory diseases
- Use of medications that may affect the autonomic nervous system
- Inability to perform the exercises required in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mandibular Stretching Exercise
Participants perform mandibular stretching exercises according to the study protocol
|
Participants perform mandibular stretching exercises according to the study protocol
|
|
Experimental: 4-4-8 Breathing Exercise
Participants perform the 4-4-8 breathing exercise according to the study protocol
|
Participants perform the 4-4-8 breathing exercise according to the study protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Autonomic Nervous System Activity
Time Frame: Baseline and 20, 40, 80, and 120 minutes after the intervention
|
Autonomic nervous system activity will be assessed by measuring heart rate (beats per minute) using a digital pulse oximeter and blood pressure (mmHg) using an automatic blood pressure monitor.
Measurements will be recorded at baseline and repeatedly after the intervention period (20, 40, 80, and 120 minutes).
|
Baseline and 20, 40, 80, and 120 minutes after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Tone
Time Frame: Baseline and 20, 40, 80, and 120 minutes after the intervention
|
Muscle activity of the temporalis and masseter muscles will be assessed using surface electromyography (EMG).
EMG amplitude (microvolts, µV) will be recorded at baseline and repeatedly after the intervention period (20, 40, 80, and 120 minutes).
|
Baseline and 20, 40, 80, and 120 minutes after the intervention
|
|
Psychological State
Time Frame: Baseline and 20, 40, 80, and 120 minutes after the intervention
|
Psychological state will be assessed using the State-Trait Anxiety Inventory (STAI) questionnaire.
STAI scores (range 20-80 points) will be recorded at baseline and repeatedly after the intervention period (20, 40, 80, and 120 minutes).
|
Baseline and 20, 40, 80, and 120 minutes after the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Neslihan Altuntaş YILMAZ, PhD, Necmettin Erbakan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NEU-2025-THESIS01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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