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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05483361
Other study ID # P.T.REC/012/003600
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date January 1, 2023

Study information

Verified date July 2022
Source Cairo University
Contact yasmine eletreby
Phone +201554984342
Email yeletreby@horus.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Statement of the problem: Are there relations between smartphone addiction, neck posture, pulmonary functions and functional capacity in children? Null hypothesis It will be assumed that: - There will be no effect of smart phone addiction on head posture, pulmonary function and functional capacity in children. - There will be no relation between smartphone addiction, head posture, pulmonary function and functional capacity in children.


Description:

Subjects: Sample size estimation will be carried out to determine the recruited number of children selected randomly from both governmental and private primary and preparatory schools at El Mansoura educational administration, Dakahlia Governorate and Damietta governorate to participate in this study. The survey targets the normal students from both sexes. They will be selected based on the following: Inclusion criteria: - All children will be age ranges from 10 to 12 years - The BMI <95th percentile (WHO, 2007) - Smartphone addiction scale short version will be used to categorize the children to addicted group (score > 32) (Kwon et al., 2013) . - They will be cooperative and followed the instructions. Exclusive criteria: Children will be excluded from the study if they have: - Neurological diseases. - Respiratory disorders. - Congenital deformities. - Vision disorders not corrected by glasses. - Children who participate in competitive sports. - Obesity.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 12 Years
Eligibility Inclusion Criteria: - All children will be age ranges from 10 to 12 years - The BMI <95th percentile (WHO, 2007) - Smartphone addiction scale short version will be used to categorize the children to addicted group (score > 32) (Kwon et al., 2013) . - They will be cooperative and followed the instructions. Exclusion Criteria: - • Neurological diseases. - Respiratory disorders. - Congenital deformities. - Vision disorders not corrected by glasses. - Children who participate in competitive sports. - Obesity.

Study Design


Locations

Country Name City State
Egypt Governmental and Private Primary and Preparatory Schools Damietta

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other evaluation craniovertebral angle By Kinovea computer program A free 2D motion analysis software baseline only
Primary evaluation of pulmonary functions Computerized spirometer is the most frequently used measure of lung function and is a measure of volume against time. It is a simple and quick procedure to perform baseline only
Secondary evaluation of functional capacity By 3 minutes step test It is based on the principles that your heart rate will return to normal quickly the fitter you are the value of post- exercise heart is considered to be an indicator to cardiovascular fitness baseline only
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