Adolescent BehaviorNCT05253885
Smartphone Addiction in Relation to Trunk Position Sense, Fatigue and Insomnia in Adolescences
An observational study of Adolescent Behavior and Smartphone Addiction, run by October 6 University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 17 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Smartphone Addiction
- What is being tested?
- Smartphone use
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2022to 15 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: - Adolescents with age between 17 and 18 years old with Smartphone addiction scale (short version) higher than 33
Who may be able to join
- 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.
Who cannot join
- Visual or hearing defects.
- Congenital abnormalities.
- Neurological abnormalities
- Musculoskeletal abnormalities
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
October 6 University hospital
Al Ḩayy Ath Thāmin, Giza Governorate, 12533
Mohamed M ElMeligie, Ph.D, 01064442032 ext. +2, mohamed.magdy.pt@o6u.edu.eg
About this study
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.
- Conditions
- Adolescent Behavior, Smartphone Addiction
- Being tested
- Smartphone use
- Medical subject headings
- Adolescent Behavior, Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone useDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone addiction group | Not described Receives: Device: Smartphone use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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"/
Measured: Single measurement (instant measure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start25 Feb 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shawky Muhammad, October 6 University
- Investigators
- Elham E Salem, Professor of Physical Therapy, Study chair, Cairo UniversityWalaa A Abdelnabie, Professor of Physical Therapy, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253885
- Sponsor's protocol ID
- smartphone003
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2022
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Addiction in Relation to Trunk Position Sense, Fatigue and Insomnia in Adolescences
- ClinicalTrials.gov ID
- NCT05253885
- Acronym / sponsor ID
- smartphone003
- Conditions
- Adolescent Behavior, Smartphone Addiction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 25 Feb 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smartphone addiction group | – | Device: Smartphone use |
Who may qualify
- Ages
- 17 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- - Adolescents with age between 17 and 18 years old with Smartphone addiction scale (short version) higher than 33
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Visual or hearing defects.
- Congenital abnormalities.
- Neurological abnormalities
- Musculoskeletal abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Smartphone addiction group |
Primary outcome
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).
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).
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"/
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elham E Salem, Professor of Physical Therapy study chair
Cairo University
Walaa A Abdelnabie, Professor of Physical Therapy study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Behavior and Smartphone Addiction, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.D (01064442032 ext. +2, mohamed.magdy.pt@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk position sense (time frame: Single measurement (instant measure)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.