NCT06818318

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 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

Study Start

First participant enrolled

June 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 5, 2025

Last Update Submit

February 8, 2025

Conditions

Keywords

smartphone addictiontemporpmandibular disordershead posturepain

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    June 1, 2024- December 1, 2024

Interventions

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.

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 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.

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.

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.

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.

Eligibility Criteria

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

University students

You may qualify if:

  • To study at Bandirma Onyedi Eylül University
  • Students between the ages of 18-30 years, whose voluntary consent was obtained and who use smartphones

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandırma Onyedi Eylül University

Balıkesir, Turkey, 10200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Internet Addiction DisorderPain

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 10, 2025

Study Start

June 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

February 11, 2025

Record last verified: 2025-02

Locations