NCT06408766

Brief 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 the relationship between strength change and tenderness of the tenar and masseter muscles depending on the intensity and duration of phone use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

June 6, 2025

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 7, 2024

Last Update Submit

June 3, 2025

Conditions

Keywords

Smartphone Addictionmasseterthenar

Outcome Measures

Primary Outcomes (6)

  • 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.

    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".

    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).

    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.

    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.

    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.

    4 months

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

University students

You may qualify if:

  • Smartphone users students between the ages of 18-30 years
  • Students whose voluntary informed consent was obtained

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandirma Onyedi Eylul University

Balıkesir, Bandirma, 10200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Internet Addiction DisorderMasticatory Muscles, Hypertrophy ofTrismus

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorSpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 10, 2024

Study Start

July 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 15, 2025

Last Updated

June 6, 2025

Record last verified: 2024-05

Locations