Smartphone AddictionNCT06408766
Investigating the Effects of Smartphone Use on the Masseter Muscle
An observational study of Smartphone Addiction and Masseter Muscle Hypertrophy, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the short- and long-term effects of smartphone use on the masseter muscle. In the short term, to investigate whether repetitive thumb movements during phone use will cause a spontaneous muscle activation and/or tenderness in the masseter muscle; in the long term, to investigate… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Smartphone Addiction, Masseter Muscle Hypertrophy, Masseter Muscle Spasm
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 15 Jan 2025
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: University students
Who may be able to join
- Smartphone users students between the ages of 18-30 years
- Students whose voluntary informed consent was obtained
Who cannot join
- Individuals undergoing masseter botox application
- Individuals diagnosed with TMJ disorder and/or bruxism
- Individuals with musculoskeletal problems with evidence of a systemic, specific pathologic condition such as fracture of the hand, finger, upper extremity and/or TMJ, rheumatoid disease
- Individuals who have undergone any surgical operation related to hand, finger, upper extremity and/or TMJ problem
- Individuals with less than 6 months of physiotherapy and rehabilitation services related to hand, finger, upper extremity and/or TMJ
- Individuals with facial paralysis
- Individuals with diagnosed psychiatric illness.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandirma Onyedi Eylul University
Balıkesir, Bandirma, 10200
About this study
Official title: Investigating the Short and Long-term Effects of Smartphone Use on the Masseter Muscle
The aim of this study was to determine the short- and long-term effects of smartphone use on the masseter muscle. In the short term, to investigate whether repetitive thumb movements during phone use will cause a spontaneous muscle activation and/or tenderness in the masseter muscle; in the long term, to investigate the relationship between strength change and tenderness of the tenar and masseter muscles depending on the intensity and duration of phone use.
Read the detailed description
A total of 120 healthy university students aged 18-30 years at Bandırma Onyedi Eylül University will be included in our study. Descriptive data form, Smartphone Addiction Scale - Short Form, Edinburg Hand Preference Inventory, pressure pain threshold, muscle activity, lateral grip strength, hand grip strength will be evaluated in the participant students.
- Keywords
- Smartphone Addiction, masseter, thenar
- Medical subject headings
- Internet Addiction Disorder, Masticatory Muscles, Hypertrophy of, Trismus
What is being measured
The primary outcome is the main question the study is designed to answer.
Smartphone Addiction Scale-Short Form
In our study, the Smartphone Addiction Scale-Short Form will be filled out to evaluate the intensity of smartphone use of students, and the daily duration of smartphone use will be recorded. This scale consists of 10 6-point Likert-type items used to measure the risk of smartphone addiction. Scores on the scale range from 10-60, with an increase in score indicating an increased risk for smartphone addiction. The cut-off score of the scale was determined as 31 for men and 33 for women in the Korean sample.
Measured: 4 months
Edinburg Hand Preference Inventory
Edinburg Hand Preference Inventory will be used to determine the dominant hand in our study. This scale asks which hand is used while performing 10 activities such as "writing", "drawing", "brushing teeth", "holding a fork (while eating)". For each activity; left hand preference is -10 points, right hand preference is +10 points and both hand preference is 0 points. After hand preference for all activities, the highest score that individuals can get is +100 and the lowest score is -100. A "negative" score is in favor of "left-handedness" and a "positive" score is in favor of "right-handedness". According to this scoring, individuals with a score between "+40 and +100" are recorded as "right-handed", individuals with a score between "-30 and +30" as "two-handed", and individuals with a score between "-100 and -40" as "left-handed".
Measured: 4 months
Pressure Pain Threshold Assessment
In our study, pressure pain threshold measurement of the dominant and non-dominant side masseter and tenar muscles before and after the activity will be evaluated with Baseline manual algometer (2.5 kg-11 lb).
Measured: 4 months
Muscle Activation Measurement
In our study, a four-channel Neurotrac Myoplus Pro 4 EMG Biofeedback device will be used for superficial electromyographic (EMG) measurements of the masseter muscle. The results of electromyographic activity will be presented as both mean data (microvolts) and normalized mean data (%MVC- Maximum Voluntary Contraction). The mean, minimum and peak contraction values of the activation will be recorded, the variability of the activation produced will be evaluated with the Inter Quantile Range (IQR). The average muscle activations that will occur in the muscle will be used as %MVC.
Measured: 4 months
Hand Grip Strength Assessment
Hand grip strength will be measured with 'Saehan Hydraulic Hand Dynamometer'. A total of three measurements will be made for each hand with a 15 s break between each measurement of the extremity and the average of the three measurements will be taken. Test results will be recorded in kilograms.
Measured: 4 months
Finger Lateral Grip Strength Assessment
Hand grip strength will be measured with 'Saehan Hydraulic pinch gauge'. Three measurements will be made for each hand in total with a 30-second break between each measurement and the average of the three measurements will be recorded in kilograms.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Jul 2024
- Primary completion1 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smartphone AddictionStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazel Çelik Güzel, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408766
- Sponsor's protocol ID
- 2024-26
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Short and Long-term Effects of Smartphone Use on the Masseter Muscle
- ClinicalTrials.gov ID
- NCT06408766
- Acronym / sponsor ID
- 2024-26
- Keywords
- Smartphone Addiction, masseter, thenar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 10 May 2024 (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 was to determine the short- and long-term effects of smartphone use on the masseter muscle. In the short term, to investigate whether repetitive thumb movements during phone use will cause a spontaneous muscle activation and/or tenderness in the masseter muscle; in the long term, to investigate the relationship between strength change and tenderness of the tenar and masseter muscles depending on the intensity and duration of phone use.
Detailed description
A total of 120 healthy university students aged 18-30 years at Bandırma Onyedi Eylül University will be included in our study. Descriptive data form, Smartphone Addiction Scale - Short Form, Edinburg Hand Preference Inventory, pressure pain threshold, muscle activity, lateral grip strength, hand grip strength will be evaluated in the participant students.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- University students
Key inclusion criteria (2 listed)
- Smartphone users students between the ages of 18-30 years
- Students whose voluntary informed consent was obtained
Key exclusion criteria (7 listed)
- Individuals undergoing masseter botox application
- Individuals diagnosed with TMJ disorder and/or bruxism
- Individuals with musculoskeletal problems with evidence of a systemic, specific pathologic condition such as fracture of the hand, finger, upper extremity and/or TMJ, rheumatoid disease
- Individuals who have undergone any surgical operation related to hand, finger, upper extremity and/or TMJ problem
- Individuals with less than 6 months of physiotherapy and rehabilitation services related to hand, finger, upper extremity and/or TMJ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Smartphone Addiction Scale-Short Form
Time frame: 4 months
In our study, the Smartphone Addiction Scale-Short Form will be filled out to evaluate the intensity of smartphone use of students, and the daily duration of smartphone use will be recorded. This scale consists of 10 6-point Likert-type items used to measure the risk of smartphone addiction. Scores on the scale range from 10-60, with an increase in score indicating an increased risk for smartphone addiction. The cut-off score of the scale was determined as 31 for men and 33 for women in the Korean sample.
Edinburg Hand Preference Inventory
Time frame: 4 months
Edinburg Hand Preference Inventory will be used to determine the dominant hand in our study. This scale asks which hand is used while performing 10 activities such as "writing", "drawing", "brushing teeth", "holding a fork (while eating)". For each activity; left hand preference is -10 points, right hand preference is +10 points and both hand preference is 0 points. After hand preference for all activities, the highest score that individuals can get is +100 and the lowest score is -100. A "negative" score is in favor of "left-handedness" and a "positive" score is in favor of "right-handedness". According to this scoring, individuals with a score between "+40 and +100" are recorded as "right-handed", individuals with a score between "-30 and +30" as "two-handed", and individuals with a score between "-100 and -40" as "left-handed".
Pressure Pain Threshold Assessment
Time frame: 4 months
In our study, pressure pain threshold measurement of the dominant and non-dominant side masseter and tenar muscles before and after the activity will be evaluated with Baseline manual algometer (2.5 kg-11 lb).
Muscle Activation Measurement
Time frame: 4 months
In our study, a four-channel Neurotrac Myoplus Pro 4 EMG Biofeedback device will be used for superficial electromyographic (EMG) measurements of the masseter muscle. The results of electromyographic activity will be presented as both mean data (microvolts) and normalized mean data (%MVC- Maximum Voluntary Contraction). The mean, minimum and peak contraction values of the activation will be recorded, the variability of the activation produced will be evaluated with the Inter Quantile Range (IQR). The average muscle activations that will occur in the muscle will be used as %MVC.
Hand Grip Strength Assessment
Time frame: 4 months
Hand grip strength will be measured with 'Saehan Hydraulic Hand Dynamometer'. A total of three measurements will be made for each hand with a 15 s break between each measurement of the extremity and the average of the three measurements will be taken. Test results will be recorded in kilograms.
Finger Lateral Grip Strength Assessment
Time frame: 4 months
Hand grip strength will be measured with 'Saehan Hydraulic pinch gauge'. Three measurements will be made for each hand in total with a 30-second break between each measurement and the average of the three measurements will be recorded in kilograms.
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 6 Jun 2025.
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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. 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 Smartphone Addiction and Masseter Muscle Hypertrophy, run by Bandırma Onyedi Eylül University 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 2 inclusion and 7 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 6 Jun 2025. 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?
Smartphone Addiction Scale-Short Form (time frame: 4 months). The study lists 6 primary outcomes in all. 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 6 Jun 2025.