- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05253885
Smartphone Addiction in Relation to Trunk Position Sense, Fatigue and Insomnia in Adolescences
February 14, 2022 updated by: Shaimaa Shawky Muhammad, October 6 University
The aim of the study is to evaluate the relationship between smartphone addiction and trunk position sense, insomnia and fatigue in adolescents.
Sample size will be determined after a pilot study conducted on a small sample of adolescents.
Digital goniometer will be used to evaluate trunk position sense, insomnia severity index will be used to evaluate insomnia severity and fatigue will be measured by fatigue severity scale.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed M ElMeligie, Ph.D
- Phone Number: +2 01064442032
- Email: mohamed.magdy.pt@o6u.edu.eg
Study Locations
-
-
Giza
-
Al Ḩayy Ath Thāmin, Giza, Egypt, 12533
- Recruiting
- October 6 university hospital
-
Contact:
- Mohamed M ElMeligie, Ph.D
- Phone Number: +2 01064442032
- Email: mohamed.magdy.pt@o6u.edu.eg
-
-
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
17 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
- Adolescents with age between 17 and 18 years old with Smartphone addiction scale (short version) higher than 33
Description
Inclusion Criteria:
- Adolescents with age between 17 and 18 years old.
- BMI between 16.4 and 24.8 kg/m2
- Smartphone addiction scale (short version) higher than 33
- Smartphone users of 4-5 inches screen size smartphones, weighing 140-160 grams and dimensions less than 159*79*9 mm.
Exclusion Criteria:
- Visual or hearing defects.
- Congenital abnormalities.
- Neurological abnormalities
- Musculoskeletal abnormalities
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Smartphone addiction group
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk position sense
Time Frame: Single measurement (instant measure)
|
Digital goniometer will be used to determine trunk position sense.
Procedure will be performed with open-closed eye positions with a trunk flexion and trunk lateral bending right/left without any verbal feedback from the examiner.
It will be measured in terms of repositioning error angle (the difference between reached and targeted angles).
|
Single measurement (instant measure)
|
|
Insomnia severity index
Time Frame: Single measurement (instant measure)
|
Insomnia severity will be assessed by insomnia severity index.
It contains 7 items and each participant will read each statement and check a number from 0 to 4. respondents use five point LIKERT scale to rate each item (example: 0= no problem, 4= very severe problems).
|
Single measurement (instant measure)
|
|
Fatigue severity scale
Time Frame: Single measurement (instant measure)
|
Arabic version of fatigue severity scale will be used to determine fatigue level.
It contains 9 items as each participant will be asked to read each statement and circle a number from 1(completely disagree) to 7 "completely agree"/
|
Single measurement (instant measure)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Elham E Salem, Professor of Physical Therapy, Cairo University
- Study Director: Walaa A Abdelnabie, Professor of Physical Therapy, Cairo University
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 (Anticipated)
February 25, 2022
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
July 15, 2022
Study Registration Dates
First Submitted
February 14, 2022
First Submitted That Met QC Criteria
February 14, 2022
First Posted (Actual)
February 24, 2022
Study Record Updates
Last Update Posted (Actual)
February 24, 2022
Last Update Submitted That Met QC Criteria
February 14, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- smartphone003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.