NCT05253885

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 14, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

February 25, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

February 14, 2022

Last Update Submit

February 14, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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)

Study Arms (1)

Smartphone addiction group

Device: Smartphone use

Interventions

* 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.

Smartphone addiction group

Eligibility Criteria

Age17 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

\- Adolescents with age between 17 and 18 years old with Smartphone addiction scale (short version) higher than 33

You may qualify if:

  • 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.

You may not qualify if:

  • Visual or hearing defects.
  • Congenital abnormalities.
  • Neurological abnormalities
  • Musculoskeletal abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University hospital

Al Ḩayy Ath Thāmin, Giza Governorate, 12533, Egypt

RECRUITING

MeSH Terms

Conditions

Adolescent BehaviorInternet Addiction Disorder

Condition Hierarchy (Ancestors)

BehaviorTechnology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive Behavior

Study Officials

  • Elham E Salem, Professor of Physical Therapy

    Cairo University

    STUDY CHAIR
  • Walaa A Abdelnabie, Professor of Physical Therapy

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Mohamed M ElMeligie, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 14, 2022

First Posted

February 24, 2022

Study Start

February 25, 2022

Primary Completion

July 1, 2022

Study Completion

July 15, 2022

Last Updated

February 24, 2022

Record last verified: 2022-02

Locations