Mandibular Stretching and 4-4-8 Breathing Exercises on Autonomic Nervous System Activity (MSE-BR)

March 11, 2026 updated by: Mehin Mammadzada

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

Mandibular stretching exercises and breathing techniques may influence autonomic nervous system activity, muscle tone, and psychological state. This randomized controlled trial aims to investigate the effects of mandibular stretching exercise and the 4-4-8 breathing exercise on autonomic nervous system activity, muscle tone, and psychological parameters in healthy university students. Participants will be randomly assigned to intervention groups and evaluated before and after the intervention period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Konya
      • Konya, Konya, Turkey (Türkiye)
        • Recruiting
        • Necmettin Erbakan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mandibular Stretching Exercise
Participants perform mandibular stretching exercises according to the study protocol
Other: Mandibular Stretching Exercise
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
Other: 4-4-8 Breathing Exercise
Participants perform the 4-4-8 breathing exercise according to the study protocol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mehin Mammadzada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Neslihan Altuntaş YILMAZ, PhD, Necmettin Erbakan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEU-2025-THESIS01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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