AnxietyNCT06113822
Investigation of the Effect of Body Mass Index and Anxiety on Masseter Muscle Thickness on Ultrasonography
An observational study of Anxiety, run by Oguzhan Deveci at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of body mass index (BMI) and anxiety on masseter muscle thickness by using ultrasonography. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- ultrasonography
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Individuals in the Turkish population aged 18-45
Who may be able to join
- The study group consisted of individuals between the ages of 18 and 45 who, according to an examination of the masseter muscles under the 'Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD),' had the presence of pain in at least one region in the palpation made from three regions (origin, center, attachment zone) or had pain in chewing muscles in the preceding month.
Who cannot join
- Exluded from the study where those who had experienced any systemic discomfort from the study group, those who had undergone acute temporomandibular joint trauma, those who had experienced early occlusion of the teeth, those who were using any moving dental prosthesis, those with clenching habits, those who use cigarette-alcohol, those with temporomandibular joint discomfort, and those with unilateral chewing habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of The Effect of Body Mass Index and Anxiety on Masseter Muscle Thickness on Ultrasonography
The aim of this study is to determine the effect of body mass index (BMI) and anxiety on masseter muscle thickness by using ultrasonography.
Read the detailed description
The aim of this study is to determine the effect of body mass index (BMI) and anxiety on masseter muscle thickness by using ultrasonography.
A total of 68 patients were included in this study. Height and weight of the patients were measured. BMI was calculated. The Control Group Without Anxiety - Normal BMI (15 patients) was composed of patients in general. Working groups were formed as High BMI \& Anxiety Normal (19 patients), Normal BMI \& High Anxiety (15 patients), and High BMI \& High Anxiety (19 patients). The Hospital Anxiety Depression Scale (HADS) was applied to the participants. Muscle thickness measurements were first measured by using the high-frequency linear scanning probe of an ultrasound device to measure the contraction and relaxation of the right masseter muscle. Then, the contraction and relaxation of the left masseter muscle was measured.
- Conditions
- Anxiety
- Being tested
- ultrasonography
- Keywords
- anxiety, body mass index, masseter muscle, obesity, ultrasonography
- Medical subject headings
- Anxiety Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDevice
We used ultrasonography to measure the patients' masseter muscle thickness. Measurements were performed simultaneously for both the right and left sides using a high frequency linear scanning probe (13-6 MHz) of an ultrasound device (Fujifilm Sonosite Edge II). In order to prevent possible artifacts and oblique imaging, the probe was kept perpendicular to the skin surface, and the distance between the location of the hyperechoic linear appearance of the mandibular and temporal bone in the transverse section and the muscular fascia were measured.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Without Anxiety - Normal BMI 15 patient nonanxiety group (HAD scores ranging from 0 to 10) body mass index is normal between 18.5-24.9 Receives: Device: ultrasonography | |
| 1st working group | High BMI \& Anxiety Normal 19 Patient nonanxiety group (HAD scores ranging from 0 to 10) Those with a high body mass index are between 25 and 29.9. Receives: Device: ultrasonography | |
| 2st working group | Normal BMI \& High Anxiety (15 patients) having anxiety group (HAD scores ranging from 11 to 21) body mass index is normal between 18.5-24.9 Receives: Device: ultrasonography | |
| 3st working group | High BMI \& High Anxiety (19 patients) having anxiety group (HAD scores ranging from 11 to 21) Those with a high body mass index are between 25 and 29.9. Receives: Device: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI and anxiety
Increased BMI and the presence of anxiety cause thickening of the masseter muscle.
Measured: 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Mar 2022
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oguzhan Deveci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oguzhan Deveci, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113822
- Sponsor's protocol ID
- FiratCerrahi
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I'm undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of The Effect of Body Mass Index and Anxiety on Masseter Muscle Thickness on Ultrasonography
- ClinicalTrials.gov ID
- NCT06113822
- Acronym / sponsor ID
- FiratCerrahi
- Conditions
- Anxiety
- Keywords
- anxiety, body mass index, masseter muscle, obesity, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Oguzhan DeveciUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 2 Nov 2023 (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.
The aim of this study is to determine the effect of body mass index (BMI) and anxiety on masseter muscle thickness by using ultrasonography.
Detailed description
The aim of this study is to determine the effect of body mass index (BMI) and anxiety on masseter muscle thickness by using ultrasonography.
A total of 68 patients were included in this study. Height and weight of the patients were measured. BMI was calculated. The Control Group Without Anxiety - Normal BMI (15 patients) was composed of patients in general. Working groups were formed as High BMI \& Anxiety Normal (19 patients), Normal BMI \& High Anxiety (15 patients), and High BMI \& High Anxiety (19 patients). The Hospital Anxiety Depression Scale (HADS) was applied to the participants. Muscle thickness measurements were first measured by using the high-frequency linear scanning probe of an ultrasound device to measure the contraction and relaxation of the right masseter muscle. Then, the contraction and relaxation of the left masseter muscle was measured.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Device: ultrasonographyWithout Anxiety - Normal BMI 15 patient nonanxiety group (HAD scores ranging from 0 to 10) body mass index is normal between 18.5-24.9 |
| 1st working group | – | Device: ultrasonographyHigh BMI \& Anxiety Normal 19 Patient nonanxiety group (HAD scores ranging from 0 to 10) Those with a high body mass index are between 25 and 29.9. |
| 2st working group | – | Device: ultrasonographyNormal BMI \& High Anxiety (15 patients) having anxiety group (HAD scores ranging from 11 to 21) body mass index is normal between 18.5-24.9 |
| 3st working group | – | Device: ultrasonographyHigh BMI \& High Anxiety (19 patients) having anxiety group (HAD scores ranging from 11 to 21) Those with a high body mass index are between 25 and 29.9. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals in the Turkish population aged 18-45
Key inclusion criteria (1 listed)
- The study group consisted of individuals between the ages of 18 and 45 who, according to an examination of the masseter muscles under the 'Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD),' had the presence of pain in at least one region in the palpation made from three regions (origin, center, attachment zone) or had pain in chewing muscles in the preceding month.
Key exclusion criteria (1 listed)
- Exluded from the study where those who had experienced any systemic discomfort from the study group, those who had undergone acute temporomandibular joint trauma, those who had experienced early occlusion of the teeth, those who were using any moving dental prosthesis, those with clenching habits, those who use cigarette-alcohol, those with temporomandibular joint discomfort, and those with unilateral chewing habits.
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 |
|---|---|---|
| ultrasonographyWe used ultrasonography to measure the patients' masseter muscle thickness. Measurements were performed simultaneously for both the right and left sides using a high frequency linear scanning probe (13-6 MHz) of an ultrasound device (Fujifilm Sonosite Edge II). In order to prevent possible artifacts and oblique imaging, the probe was kept perpendicular to the skin surface, and the distance between the location of the hyperechoic linear appearance of the mandibular and temporal bone in the transverse section and the muscular fascia were measured. | Device | 1st working group, 2st working group, 3st working group, Control Group |
Primary outcome
BMI and anxiety
Time frame: 2022
Increased BMI and the presence of anxiety cause thickening of the masseter muscle.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: Undecided. I'm undecided
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Oguzhan Deveci 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI and anxiety (time frame: 2022). 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 3 Nov 2023.