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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05253885
Other study ID # smartphone003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 25, 2022
Est. completion date July 15, 2022

Study information

Verified date February 2022
Source October 6 University
Contact Mohamed M ElMeligie, Ph.D
Phone 01064442032
Email mohamed.magdy.pt@o6u.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date July 15, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 17 Years to 18 Years
Eligibility 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 Design


Intervention

Device:
Smartphone use
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.

Locations

Country Name City State
Egypt October 6 University hospital Al ?ayy Ath Thamin Giza

Sponsors (1)

Lead Sponsor Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Trunk position sense 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)
Primary Insomnia severity index 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)
Primary Fatigue severity scale 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)
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