- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04256031
Effects of Smartphone Use on Posture, Pain, Function and QoL
June 30, 2020 updated by: Sıla Yılmaz, Yeditepe University
Evaluation of the Effects of Smartphone Use on Posture, Pain, Function and Quality of Life in Young Adults
The aim of the study is to determine the effects of the use of smartphone on the neck and shoulder posture, pain, and functions, and the quality of life in young adults.
The sample of the study consists of university students.
According to the scores they got from the Smartphone Addiction Scale-Short Version, all participants will be divided into two groups.
The neck and shoulder posture, pain, and functions, and the quality of life will be compared between the two groups.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The study will include 106 university students who are 18-25 years old.
According to the scores they got from the Smartphone Addiction Scale-Short Version, all students will be divided into two groups as Excessive Smartphone Use Group and Non-excessive Smartphone Use Group, both consisting of 53 participants.
Participants whose scores are higher than 30 will be included to the Excessive Smartphone Use Group, and whose scores are 30 or less will be included to the Non-excessive Smartphone Use Group.
In the assessment of pain level, the Visual Analogue Scale will be used.
Functional levels of the neck and shoulders will be evaluated with the Copenhagen Neck Functional Disability Scale and the Shoulder Disability Questionnaire.
World Health Organization Quality of Life Instrument-Short Form will be utilized to assess the quality of life.
Postural analyzes of the participants will be fulfilled with the New York Posture Rating Chart.
All scores will be evaluated by comparing between the two groups.
Study Type
Observational
Enrollment (Actual)
106
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Yeditepe University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The sample of the study will consist of university students.
Description
Inclusion Criteria:
- To be willing and volunteer to participate in the study
- To be between 18 and 25 years old
- To have been using smartphone for more than 1 year
Exclusion Criteria:
- To have any health problem history or diagnosed pathology related with the neck or shoulder regions
- To have any history of trauma or surgery related to the neck or shoulder regions
- To have received any medical attention or treatment in the last six months because of a health problem related to neck or shoulder
- To have any diagnosed neurological problem
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Excessive Smartphone Use Group
Participants whose Smartphone Addiction Scale-Short Version scores are higher than 30
|
The structured questionnaire, Visual Analogue Scale, Copenhagen Neck Functional Disability Scale, Shoulder Disability Questionnaire, World Health Organization Quality of Life Instrument-Short Form, and Smartphone Addiction Scale-Short Version will be applied to all participants respectively.
Lastly, posture analysis will be performed to all participants by using the New York Posture Rating Chart.
|
Non-excessive Smartphone Use Group
Participants whose Smartphone Addiction Scale-Short Version scores are 30 or less
|
The structured questionnaire, Visual Analogue Scale, Copenhagen Neck Functional Disability Scale, Shoulder Disability Questionnaire, World Health Organization Quality of Life Instrument-Short Form, and Smartphone Addiction Scale-Short Version will be applied to all participants respectively.
Lastly, posture analysis will be performed to all participants by using the New York Posture Rating Chart.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Posture
Time Frame: 1 day (Instant single measure)
|
Posture will be examined with New York Posture Rating Chart which is a quantitative approach to assess the alignment of various body parts from posterior and lateral.
The total score calculated after the evaluation is at most 65, and at least 13.
The low score indicates impairments in posture.
|
1 day (Instant single measure)
|
Pain level
Time Frame: 1 day (Instant single measure)
|
In the assessment of the neck and shoulder pain levels the Visual Analogue Scale will be used.
This scale is 10 cm long, and has two ends on a horizontal line.
One of these two ends is called as "0", while one is named as "10".
"0" point defines no pain, and "10" points describe the most severe pain.
|
1 day (Instant single measure)
|
Neck function
Time Frame: 1 day (Instant single measure)
|
Functional level of the neck will be evaluated with the Copenhagen Neck Functional Disability Scale.
It is a valid and reliable tool for self-assessment of cervical pain and related disabilities, developed by Jordan el al. in 1998.
The minimum score of the scale is 0, while the maximum score is 30.
Disability level increases as the total score increases.
|
1 day (Instant single measure)
|
Shoulder function
Time Frame: 1 day (Instant single measure)
|
Functional level of the shoulder will be evaluated with the Shoulder Disability Questionnaire.
It is a 16-items disability questionnaire related to shoulder pain.
The result is calculated with a special formula, and evaluated out of 100.
Disability level increases as the total score increases.
|
1 day (Instant single measure)
|
Quality of life level
Time Frame: 1 day (Instant single measure)
|
World Health Organization Quality of Life Instrument-Short Form will be utilized to assess the quality of life of participants.
This questionnaire has been developed by World Health Organization, and has been validated in 1999 by Eser et al. in Turkish population.
The scale does not have a total score, each field of the scale is evaluated independently in itself and is scored out of 20 or 100 points.
The higher the score shows the higher the quality of life level.
|
1 day (Instant single measure)
|
Smartphone addiction level
Time Frame: 1 day (Instant single measure)
|
In determining the smartphone addiction levels of the participants, Smartphone Addiction Scale-Short Version will be utilized.
It is a self-assessment tool questioning smartphone usage, constituted by Kwon et al in 2013.
The validity and reliability study of its Turkish version was made by Noyan et al. in 2015.
The cut-off score for Turkish population was detected both for male and female students in 2017 by Şata and Karip.
The lowest score of the scale is 10, while the highest score is 60.
As the score obtained from the scale increases, the severity of smartphone addiction increases.
|
1 day (Instant single measure)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Rasmi Muammer, Professor, Yeditepe University, Department of Physiotherapy and Rehabilitation
- Principal Investigator: Sıla Yılmaz, PT, Yeditepe University, Department of Physiotherapy and Rehabilitation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2020
Primary Completion (Actual)
May 15, 2020
Study Completion (Actual)
June 15, 2020
Study Registration Dates
First Submitted
February 3, 2020
First Submitted That Met QC Criteria
February 4, 2020
First Posted (Actual)
February 5, 2020
Study Record Updates
Last Update Posted (Actual)
July 1, 2020
Last Update Submitted That Met QC Criteria
June 30, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YU1682
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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