Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT06408766
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2024-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Effects of Smartphone Use on the Masseter Muscle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082424', 'term': 'Internet Addiction Disorder'}, {'id': 'C563600', 'term': 'Masticatory Muscles, Hypertrophy of'}, {'id': 'D014313', 'term': 'Trismus'}], 'ancestors': [{'id': 'D000088942', 'term': 'Technology Addiction'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D013035', 'term': 'Spasm'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2024-05-07', 'studyFirstSubmitQcDate': '2024-05-07', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Smartphone Addiction Scale-Short Form', 'timeFrame': '4 months', 'description': '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.'}, {'measure': 'Edinburg Hand Preference Inventory', 'timeFrame': '4 months', 'description': '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".'}, {'measure': 'Pressure Pain Threshold Assessment', 'timeFrame': '4 months', 'description': '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).'}, {'measure': 'Muscle Activation Measurement', 'timeFrame': '4 months', 'description': '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.'}, {'measure': 'Hand Grip Strength Assessment', 'timeFrame': '4 months', 'description': "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."}, {'measure': 'Finger Lateral Grip Strength Assessment', 'timeFrame': '4 months', 'description': "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."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smartphone Addiction', 'masseter', 'thenar'], 'conditions': ['Smartphone Addiction', 'Masseter Muscle Hypertrophy', 'Masseter Muscle Spasm']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'University students', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smartphone users students between the ages of 18-30 years\n* Students whose voluntary informed consent was obtained\n\nExclusion Criteria:\n\n* Individuals undergoing masseter botox application\n* Individuals diagnosed with TMJ disorder and/or bruxism\n* 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\n* Individuals who have undergone any surgical operation related to hand, finger, upper extremity and/or TMJ problem\n* Individuals with less than 6 months of physiotherapy and rehabilitation services related to hand, finger, upper extremity and/or TMJ\n* Individuals with facial paralysis\n* Individuals with diagnosed psychiatric illness.'}, 'identificationModule': {'nctId': 'NCT06408766', 'briefTitle': 'Investigating the Effects of Smartphone Use on the Masseter Muscle', 'organization': {'class': 'OTHER', 'fullName': 'Bandırma Onyedi Eylül University'}, 'officialTitle': 'Investigating the Short and Long-term Effects of Smartphone Use on the Masseter Muscle', 'orgStudyIdInfo': {'id': '2024-26'}}, 'contactsLocationsModule': {'locations': [{'zip': '10200', 'city': 'Balıkesir', 'state': 'Bandirma', 'country': 'Turkey (Türkiye)', 'facility': 'Bandirma Onyedi Eylul University', 'geoPoint': {'lat': 39.64917, 'lon': 27.88611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bandırma Onyedi Eylül University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Hazel Çelik Güzel', 'investigatorAffiliation': 'Bandırma Onyedi Eylül University'}}}}