Muscle ToneMSE-BRNCT07472010
Mandibular Stretching and 4-4-8 Breathing Exercises on Autonomic Nervous System Activity
A study testing Mandibular Stretching Exercise and 4-4-8 Breathing Exercise in people with Muscle Tone and Psychological State, run by Mehin Mammadzada at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Tone, Psychological State, Autonomic Nervous System
- What is being tested?
- Mandibular Stretching Exercise and 4-4-8 Breathing Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 19 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Necmettin Erbakan University
Konya, Konya
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Tone, Psychological State, Autonomic Nervous System
- Being tested
- Mandibular Stretching Exercise, 4-4-8 Breathing Exercise
- Keywords
- Mandibular Stretching Exercise, 4-4-8 Breathing Exercise, Breathing Techniques, Autonomic Nervous System, Muscle Tone, Psychological State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular Stretching ExerciseOther
Participants perform mandibular stretching exercises according to the study protocol
4-4-8 Breathing ExerciseOther
Participants perform the 4-4-8 breathing exercise according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Mandibular Stretching Exercise | Experimental | Participants perform mandibular stretching exercises according to the study protocol Receives: Other: Mandibular Stretching Exercise |
| 4-4-8 Breathing Exercise | Experimental | Participants perform the 4-4-8 breathing exercise according to the study protocol Receives: Other: 4-4-8 Breathing Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic Nervous System Activity
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).
Measured: Baseline and 20, 40, 80, and 120 minutes after the intervention
Secondary outcomes (2)
Muscle Tone
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).
Measured: Baseline and 20, 40, 80, and 120 minutes after the intervention
Psychological State
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).
Measured: Baseline and 20, 40, 80, and 120 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start15 Dec 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion19 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle ToneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to intervention groups including mandibular stretching exercise, 4-4-8 breathing exercise, or control group. The effects of the interventions on autonomic nervous system activity, muscle tone, and psychological state will be evaluated.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mehin Mammadzada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehin Mammadzada, Necmettin Erbakan University
- Investigators
- Neslihan Altuntaş YILMAZ, PhD, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472010
- Sponsor's protocol ID
- NEU-2025-THESIS01
- Acronym
- MSE-BR
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07472010
- Acronym / sponsor ID
- MSE-BR / NEU-2025-THESIS01
- Conditions
- Muscle Tone, Psychological State, Autonomic Nervous System
- Keywords
- Mandibular Stretching Exercise, 4-4-8 Breathing Exercise, Breathing Techniques, Autonomic Nervous System, Muscle Tone, Psychological State
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Mehin MammadzadaUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 19 Jun 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to intervention groups including mandibular stretching exercise, 4-4-8 breathing exercise, or control group. The effects of the interventions on autonomic nervous system activity, muscle tone, and psychological state will be evaluated.
| Arm | Type | Receives |
|---|---|---|
| Mandibular Stretching Exercise | Experimental | Other: Mandibular Stretching ExerciseParticipants perform mandibular stretching exercises according to the study protocol |
| 4-4-8 Breathing Exercise | Experimental | Other: 4-4-8 Breathing ExerciseParticipants perform the 4-4-8 breathing exercise according to the study protocol |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandibular Stretching ExerciseParticipants perform mandibular stretching exercises according to the study protocol | Other | Mandibular Stretching Exercise |
| 4-4-8 Breathing ExerciseParticipants perform the 4-4-8 breathing exercise according to the study protocol. | Other | 4-4-8 Breathing Exercise |
Primary outcome
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).
2 secondary outcomes
Muscle Tone
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neslihan Altuntaş YILMAZ, PhD principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular Stretching Exercise and 4-4-8 Breathing Exercise in people with Muscle Tone and Psychological State, run by Mehin Mammadzada at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehin Mammadzada, MSc Student (+905313124790, mammadzadamehin01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic Nervous System Activity (time frame: Baseline and 20, 40, 80, and 120 minutes after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.