NCT05885893

Brief Summary

Background/aim:The study was conducted to determine the smartphone addiction level of youths and to investigate the effect of addiction level on neck pain, functional level, pressure pain threshold (PPT) level, and muscle activation of neck muscles (upper trapezius (UT), cervical erector spina (CES), sternocleidomastoideus (SCM)). Methods:Superficial electromyography, PPT, Visual Analog Scale (VAS), Neck Disability Index (NDI) and Smartphone Addiction Scale (SAS) were used as assessment tools.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

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

December 10, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

1.5 years

First QC Date

April 18, 2023

Last Update Submit

June 1, 2023

Conditions

Keywords

Smartphone AddictionNeck MusclesPainMuscle ActivationFunctional Status

Outcome Measures

Primary Outcomes (5)

  • Neck Pain Intensity Assessment

    The Visual Analogue Scale (VAS) was used to evaluate the neck pain intensity. VAS is a continuous scale, it is a horizontal line of 100 mm in length, anchored by 2 adjectives: zero representing no pain in the left anchor and 10 representing worst imaginable pain at the right anchor. The participant was asked to mark the point corresponding to the intensity of pain felt on this line. The numerical value found indicates the pain severity of the participants.

    1 month

  • Smartphone Addiction Level Assessment

    The smartphone addiction level was assessed by Smartphone Addiction Scale (SAS). The assessment of validity and reliability of its Turkish version in a younger population was performed. SAS is a suitable tool for assessing smartphone addiction in younger population. The scale consists of 7 factors that evaluate daily life disturbance and tolerance (1. factor), withdrawal symptoms (2. factor), positive expectation (3. factor), cyber-oriented relationships (4. factor), excessive use (5. factor), social network addiction (6. factor) and physical symptoms (7. factor). The scores on the scale can range from 33 to 198. High score indicating a more serious smartphone addiction level.

    1 month

  • Functional Level Assessment

    Functional level was assessed by the Neck Disability Index (NDI). The assessment of validity and reliability of its Turkish version was performed. Survey questions; Daily life activities such as lifting, working, driving, resting consist of 4 titles, optional activities in daily life such as personal care consist of 2 titles, and subjective symptoms such as pain sensitivity, headache, concentration, sleep consist of 4 titles. The highest score is 50 and the lowest score is 0. Classification by total score; 0-4 points no disability, 5-14 points mild disability, 15-24 points moderate disability, 25-34 points severe disability, 34 points and above completely disability. The participants were asked to answer the questions based on the neck pain they felt during the past 1 week.

    1 month

  • Pain Sensitivity Level Assessment

    Pressure pain threshold (PPT) is used to assess sensitivity to pain and pressure perception. Using a Wagner Instruments, Force Dial (TM FDK/FDN, Greenwich, CT, USA) device, a constant force of 1 kg / cm2 was applied to the CES, UT and SCM muscles bilaterally. The pressure pain threshold measurement at each site was repeated three times and the average of the three repetitions was used for further analysis. Participants rested for 5 minutes between each measurement.

    1 month

  • Muscle Activation Level Assessment

    The activation of neck muscles consisting of SCM, UT and CES muscles were measured by surface electromyography (sEMG). Measurements were made in the resting position bilaterally. For the resting position, the patient was evaluated in a chair without back support, in a sitting position with arms supported in front, and a posture without pain.

    1 month

Eligibility Criteria

Age15 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

A total of 112 male university students studying at Süleyman Demirel University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation were included in study.

You may qualify if:

  • to be studying at Süleyman Demirel University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation,
  • volunteering to participate in the study,
  • for the past 6 months, using a smartphone for at least 2 hours a day.

You may not qualify if:

  • a history of surgical intervention or traumatic injury in the spine and upper extremity,
  • chronic disease affecting the musculoskeletal system such as rheumatoid arthritis, osteoarthritis and other connective soft tissue diseases,
  • sensory impairment in the spine or upper extremities to have a neurological and orthopedic disorder,
  • activities such as long-term reading, which will affect the flexion posture of the head, have been performed in the last 1 month,
  • having done exercises involving neck muscles in the last 1 month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menekşe ŞAFAK

Merkez, Isparta, 32000, 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
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2023

First Posted

June 2, 2023

Study Start

December 10, 2017

Primary Completion

June 1, 2019

Study Completion

June 15, 2019

Last Updated

June 2, 2023

Record last verified: 2023-05

Locations