Smartphone AddictionNCT06818318
Smartphone Addiction and Temporomandibular Dysfunction
An observational study of Smartphone Addiction, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effect of smartphone addiction on temporomandibular dysfunction with the determinants of pain threshold, head posture and neck disability level. 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
- What is being tested?
- Temporomandibular disorder, Smartphone Addiction Scale-Short Form and Neck Disability Index
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Dec 2024
- How long will I take part?
- 1 Day
- 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
- To study at Bandirma Onyedi Eylül University
- Students between the ages of 18-30 years, whose voluntary consent was obtained and who use smartphones
Who cannot join
- Individuals undergoing masseter botox application
- Individuals diagnosed with TMJ disorder and/or bruxism
- Individuals with musculoskeletal system problems such as fractures of the hand, fingers, upper extremities and/or TMJ, rheumatoid disease with evidence of systemic, specific pathological conditions
- Individuals who have undergone any surgical operation related to hand, finger, upper extremity and/or TMJ problem
- Individuals who have received hand, finger, upper extremity and/or TMJ-related physiotherapy and rehabilitation services in less than 6 months
- Individuals with facial paralysis
- Individuals with diagnosed psychiatric illness.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandırma Onyedi Eylül University
Balıkesir, Turkey, 10200
About this study
Official title: The Effect of Smartphone Addiction on Temporomandibular Dysfunction
The aim of this study was to investigate the effect of smartphone addiction on temporomandibular dysfunction with the determinants of pain threshold, head posture and neck disability level.
Read the detailed description
Firstly, the purpose of the research and the evaluation methods were explained to the students. Students who volunteered to participate in the study and met the inclusion criteria were included in the evaluation. Approval was obtained from the evaluated students with the 'Informed Voluntary Consent Form'. Then, the students will fill in the Descriptive Data Form. The risk of smartphone addiction of the students who filled out the Descriptive Data Form was assessed with the Smartphone Addiction Scale-Short Form, TMD dysfunction status was assessed with the Fonseca Anamnestic Index, neck disability status was assessed with the Neck Disability Index, TMJ pain was assessed with the Numeric Pain Scale, head posture was assessed with a goniometer, and pressure pain threshold of the tenar and masseter muscles was assessed with an algometer. The evaluations took an average of 45 minutes for each student. The evaluations of the students were performed only once.
- Conditions
- Smartphone Addiction
- Being tested
- Temporomandibular disorder, Smartphone Addiction Scale-Short Form, Neck Disability Index, Temporomandibular Joint Pain, Anterior posture of the head
- Keywords
- smartphone addiction, temporpmandibular disorders, head posture, pain
- Medical subject headings
- Internet Addiction Disorder, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporomandibular disorderOther
Fonseca's Anamnestic Index was used for TMJ dysfunction. The diagnostic accuracy of the Fonseca's Anamnestic Index was found to be high in identifying pain-related and intra-articular TMDs, and the cut-off point was set as 25 points. A score of 25 and above was accepted as the presence of TMD.
Smartphone Addiction Scale-Short FormOther
In our study, the Smartphone Addiction Scale-Short Form will be filled out in order to evaluate the intensity of smartphone use of students, and the daily duration of smartphone use will be recorded. The Smartphone Addiction Scale-Short Form is a 6-point Likert-type scale consisting of 10 items used to measure the risk of smartphone addiction. Scores obtained from the scale vary between 10-60, and an increase in the score indicates an increased risk for smartphone addiction. Although the scale does not have a cut-off score in our country, it was determined as 31 for men and 33 for women in the Korean sample.
Neck Disability IndexOther
The Neck Disability Index was used to assess the disability caused by neck pain. This questionnaire consists of ten items, four of which are related to subjective symptoms (pain intensity, headache, concentration, sleep) and six of which are related to activities of daily living (self-care, lifting, reading, work, driving and leisure activities). Scale scoring ranges from 0-40.
Temporomandibular Joint PainOther
Numeric Pain Scale is a simple, reliable and short-term method commonly used in the clinic to measure pain intensity. It is a very reliable method in the evaluation of pharmacological and nonpharmacological treatments that reduce pain. The patient is told that the most severe pain he/she experiences is 10, and if he/she has no pain, the pain intensity is 0. The participant was asked to say a number between 0 and 10 corresponding to the intensity of pain felt in the TMJ region.
Anterior posture of the headOther
The anterior posture of the head was assessed with the Craniovertebral angle using a goniometer. The Craniovertebral angle was measured in degrees as the angle between the horizontal plane and the 7th cervical vertebra and the ear hole.
Pressure Pain Threshold AssessmentOther
In our study, the pressure pain threshold measurement of the dominant and non-dominant side masseter and tenar muscles was evaluated with Baseline manual algometer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporomandibular disorder
Fonseca's Anamnestic Questionnaire was used for TMJ dysfunction. The diagnostic accuracy of the Fonseca's Anamnestic Questionnaire was found to be high in identifying pain-related and intra-articular TMDs, and the cut-off point was set as 25 points. A score of 25 and above was accepted as the presence of TMD.
Measured: June 1, 2024- December 1, 2024
Smartphone Addiction Scale-Short Form
In our study, the Smartphone Addiction Scale-Short Form will be filled out in order to evaluate the intensity of smartphone use of students, and the daily duration of smartphone use will be recorded. The Smartphone Addiction Scale-Short Form is a 6-point Likert-type scale consisting of 10 items used to measure the risk of smartphone addiction. Scores obtained from the scale vary between 10-60, and an increase in the score indicates an increased risk for smartphone addiction. Although the scale does not have a cut-off score in our country, it was determined as 31 for men and 33 for women in the Korean sample.
Measured: June 1, 2024- December 1, 2024
The Neck Disability Index
The Neck Disability Index was used to assess the disability caused by neck pain. This questionnaire consists of ten items, four of which are related to subjective symptoms (pain intensity, headache, concentration, sleep) and six of which are related to activities of daily living (self-care, lifting, reading, work, driving and leisure activities). Scale scoring ranges from 0-40.
Measured: June 1, 2024- December 1, 2024
Temporomandibular Joint Pain
Numeric Pain Scale is a simple, reliable and short-term method commonly used in the clinic to measure pain intensity. It is a very reliable method in the evaluation of pharmacological and nonpharmacological treatments that reduce pain. The patient is told that the most severe pain he/she experiences is 10, and if he/she has no pain, the pain intensity is 0. The participant was asked to say a number between 0 and 10 corresponding to the intensity of pain felt in the TMJ region.
Measured: June 1, 2024- December 1, 2024
Anterior head posture
The anterior posture of the head was assessed with the Craniovertebral angle using a goniometer. The Craniovertebral angle was measured in degrees as the angle between the horizontal plane and the 7th cervical vertebra and the ear hole.
Measured: June 1, 2024- December 1, 2024
Pressure pain threshold assessment
In our study, the pressure pain threshold measurement of the dominant and non-dominant side masseter and tenar muscles was evaluated with Baseline manual algometer.
Measured: June 1, 2024- December 1, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Jun 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
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
- 110 participants (actual)
- Target duration
- 1 Day
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
- NCT06818318
- Sponsor's protocol ID
- 2024-27
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Smartphone Addiction on Temporomandibular Dysfunction
- ClinicalTrials.gov ID
- NCT06818318
- Acronym / sponsor ID
- 2024-27
- Conditions
- Smartphone Addiction
- Keywords
- smartphone addiction, temporpmandibular disorders, head posture, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 10 Feb 2025 (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 investigate the effect of smartphone addiction on temporomandibular dysfunction with the determinants of pain threshold, head posture and neck disability level.
Detailed description
Firstly, the purpose of the research and the evaluation methods were explained to the students. Students who volunteered to participate in the study and met the inclusion criteria were included in the evaluation. Approval was obtained from the evaluated students with the 'Informed Voluntary Consent Form'. Then, the students will fill in the Descriptive Data Form. The risk of smartphone addiction of the students who filled out the Descriptive Data Form was assessed with the Smartphone Addiction Scale-Short Form, TMD dysfunction status was assessed with the Fonseca Anamnestic Index, neck disability status was assessed with the Neck Disability Index, TMJ pain was assessed with the Numeric Pain Scale, head posture was assessed with a goniometer, and pressure pain threshold of the tenar and masseter muscles was assessed with an algometer. The evaluations took an average of 45 minutes for each student. The evaluations of the students were performed only once.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
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)
- To study at Bandirma Onyedi Eylül University
- Students between the ages of 18-30 years, whose voluntary consent was obtained and who use smartphones
Key exclusion criteria (7 listed)
- Individuals undergoing masseter botox application
- Individuals diagnosed with TMJ disorder and/or bruxism
- Individuals with musculoskeletal system problems such as fractures of the hand, fingers, upper extremities and/or TMJ, rheumatoid disease with evidence of systemic, specific pathological conditions
- Individuals who have undergone any surgical operation related to hand, finger, upper extremity and/or TMJ problem
- Individuals who have received hand, finger, upper extremity and/or TMJ-related physiotherapy and rehabilitation services in less than 6 months
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 |
|---|---|---|
| Temporomandibular disorderFonseca's Anamnestic Index was used for TMJ dysfunction. The diagnostic accuracy of the Fonseca's Anamnestic Index was found to be high in identifying pain-related and intra-articular TMDs, and the cut-off point was set as 25 points. A score of 25 and above was accepted as the presence of TMD. | Other | – |
| Smartphone Addiction Scale-Short FormIn our study, the Smartphone Addiction Scale-Short Form will be filled out in order to evaluate the intensity of smartphone use of students, and the daily duration of smartphone use will be recorded. The Smartphone Addiction Scale-Short Form is a 6-point Likert-type scale consisting of 10 items used to measure the risk of smartphone addiction. Scores obtained from the scale vary between 10-60, and an increase in the score indicates an increased risk for smartphone addiction. Although the scale does not have a cut-off score in our country, it was determined as 31 for men and 33 for women in the Korean sample. | Other | – |
| Neck Disability IndexThe Neck Disability Index was used to assess the disability caused by neck pain. This questionnaire consists of ten items, four of which are related to subjective symptoms (pain intensity, headache, concentration, sleep) and six of which are related to activities of daily living (self-care, lifting, reading, work, driving and leisure activities). Scale scoring ranges from 0-40. | Other | – |
| Temporomandibular Joint PainNumeric Pain Scale is a simple, reliable and short-term method commonly used in the clinic to measure pain intensity. It is a very reliable method in the evaluation of pharmacological and nonpharmacological treatments that reduce pain. The patient is told that the most severe pain he/she experiences is 10, and if he/she has no pain, the pain intensity is 0. The participant was asked to say a number between 0 and 10 corresponding to the intensity of pain felt in the TMJ region. | Other | – |
| Anterior posture of the headThe anterior posture of the head was assessed with the Craniovertebral angle using a goniometer. The Craniovertebral angle was measured in degrees as the angle between the horizontal plane and the 7th cervical vertebra and the ear hole. | Other | – |
| Pressure Pain Threshold AssessmentIn our study, the pressure pain threshold measurement of the dominant and non-dominant side masseter and tenar muscles was evaluated with Baseline manual algometer. | Other | – |
Primary outcome
Temporomandibular disorder
Time frame: June 1, 2024- December 1, 2024
Fonseca's Anamnestic Questionnaire was used for TMJ dysfunction. The diagnostic accuracy of the Fonseca's Anamnestic Questionnaire was found to be high in identifying pain-related and intra-articular TMDs, and the cut-off point was set as 25 points. A score of 25 and above was accepted as the presence of TMD.
Smartphone Addiction Scale-Short Form
Time frame: June 1, 2024- December 1, 2024
In our study, the Smartphone Addiction Scale-Short Form will be filled out in order to evaluate the intensity of smartphone use of students, and the daily duration of smartphone use will be recorded. The Smartphone Addiction Scale-Short Form is a 6-point Likert-type scale consisting of 10 items used to measure the risk of smartphone addiction. Scores obtained from the scale vary between 10-60, and an increase in the score indicates an increased risk for smartphone addiction. Although the scale does not have a cut-off score in our country, it was determined as 31 for men and 33 for women in the Korean sample.
The Neck Disability Index
Time frame: June 1, 2024- December 1, 2024
The Neck Disability Index was used to assess the disability caused by neck pain. This questionnaire consists of ten items, four of which are related to subjective symptoms (pain intensity, headache, concentration, sleep) and six of which are related to activities of daily living (self-care, lifting, reading, work, driving and leisure activities). Scale scoring ranges from 0-40.
Temporomandibular Joint Pain
Time frame: June 1, 2024- December 1, 2024
Numeric Pain Scale is a simple, reliable and short-term method commonly used in the clinic to measure pain intensity. It is a very reliable method in the evaluation of pharmacological and nonpharmacological treatments that reduce pain. The patient is told that the most severe pain he/she experiences is 10, and if he/she has no pain, the pain intensity is 0. The participant was asked to say a number between 0 and 10 corresponding to the intensity of pain felt in the TMJ region.
Anterior head posture
Time frame: June 1, 2024- December 1, 2024
The anterior posture of the head was assessed with the Craniovertebral angle using a goniometer. The Craniovertebral angle was measured in degrees as the angle between the horizontal plane and the 7th cervical vertebra and the ear hole.
Pressure pain threshold assessment
Time frame: June 1, 2024- December 1, 2024
In our study, the pressure pain threshold measurement of the dominant and non-dominant side masseter and tenar muscles was evaluated with Baseline manual algometer.
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 11 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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, 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 11 Feb 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?
Temporomandibular disorder (time frame: June 1, 2024- December 1, 2024). 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 11 Feb 2025.