Internet Gaming DisorderNCT04631523
Investigation of the Relationship Between Internet Gaming Disorder and Sensorimotor Functions in Adolescents
An observational study of Internet Gaming Disorder, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Using computer for long have been shown to cause vision problems, musculoskeletal pain particularly in neck, postural deviations, obesity and physical inactivity in several studies. Read more about this study
- Who is it for?
- Ages 10 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Internet Gaming Disorder
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2021to 15 Jan 2023
- 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 10 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: This study will include 60 male adolescents diagnosed with Internet Gaming Disorder by the psychiatrist in Basaksehir Cam and Sakura City Hospital Child and Adolescent Psychiatry, Istanbul. The individuals who volunteers and meets the inclusion criteria will be included in the study.
Who may be able to join
- For healthy group as follows:
- being male in age between 10-18 years old
- having accepted the research on a voluntary basis and signed the informed consent.
- For the experimental group, being diagnosed with IGD according to DSM-5 is an additional criterion.
Who cannot join
- being diagnosed with psychotic, bipolar, or autism spectrum disorder
- the presence of mental retardation in the child or family that prevents answering the questions and following the instructions properly in clinical assessment
- Use of psychotropic drugs.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul University-Cerrahpaşa
Istanbul, 34500
About this study
Official title: Investigation of the Relationship Between Internet Gaming Disorder and Reaction Time, Motor Dexterity, Neck Posture and Proprioception in Adolescents
Using computer for long have been shown to cause vision problems, musculoskeletal pain particularly in neck, postural deviations, obesity and physical inactivity in several studies. The relation between obesity and physical activity, neck pain and postural deviations with altered sensorimotor function has been also shown with many studies. However, there were not enough study that assess sensorimotor congruence such as proprioception and reaction time in adolescents diagnosed with Internet Gaming Disorder (IGD). This study aimed to evaluate the proprioception and reaction time and investigate its relation with the relationship with neck pain, proprioception and reaction time in adolescents with IGD.
Read the detailed description
The aim of this study is to evaluate reaction time, motor dexterity, cervical posture and proprioception and its relationship with Internet Gaming Disorder (IGD) in adolescents. It's anticipated that 60 adolescents aged between 10-18 years will be included to this study (30 healthy adolescent; 30 adolescent with IGD. After recording sociodemografic data of participants, age of starting to use the internet, the age of starting to play games on the internet, the time spent on the internet, the name and type of the game played will be questioned. The presence of musculoskeletal pain and its localization, if any, will be recorded. The severity of internet addiction will be assessed with Internet Addiction Scale, motor dexterity will be assessed with The 9 Hole Peg Test, reaction time of upper extremity will be assessed with Ruler Drop Method, the severity of forward head posture will be assessed with Cervical Range of Motion (CROM) device, and lastly, proprioception of cervical region will be assessed with Joint Position Error which will be evaluated CROM device. All parameters will be compared between healthy adolescents and adolescents with IGD.
- Conditions
- Internet Gaming Disorder
- Keywords
- internet gaming disorder, fine motor skills, adolescent, sensorimotor function
- Medical subject headings
- Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IGD Group | The eligibility criteria were for IGD group as follows: being male in age between 10-18 years old; having accepted the research on a voluntary basis and signed the informed consent and being diagnosed with IGD according to DSM-5. Healthy adolescents in this study will be referred from a child and adolescent psychiatrist. All the following assessments will be applied this group for one time; Internet Addiction Scale, 9 Hole Peg Test, Ruler Drop Method, assessment of Forward Head Posture, evaluation of Joint Position Error of cervical region. | |
| Healthy Group | The eligibility criteria were for healthy group as follows: being male in age between 10-18 years old and having accepted the research on a voluntary basis and signed the informed consent. The adolescents with IGD in this study will be referred from a child and adolescent psychiatrist. All the following assessments will be applied this group for one time; Internet Addiction Scale, 9 Hole Peg Test, Ruler Drop Method, assessment of Forward Head Posture, evaluation of Joint Position Error of cervical region. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internet Addiction Scale
It is a 20-itemed Likert type scale whose items are grading "Rarely", "Occasionally", "Often", "Most of the time" or "Always" with points of 1,2,3,4,5, respectively. The lowest score that can be obtained from the test is 20 and the highest score is 100. A score of 80 and above is an indicator of significant impairment in functionality and this group was defined as "internet addicted". Scores of "49 points and below" were defined as the "average internet user" who does not have any problems related to internet use in his life.
Measured: baseline
Secondary outcomes (4)
9 Hole Peg Test
The pegboard will be placed on table at midline of the body. The height of the table will be same at the participants' chest level. The participants will be asked to place the nine sticks into nine holes as quickly as possible and remove them immediately after finishing. The time will be begin on the first contact with the first stick and stopped last stick dropped.
Measured: baseline
Ruler Drop Method
Ruler Drop Method will be used to assess reaction time. Participants will be made to sit with their dominant arm on table, elbow will be flexed at 90º and forearm will be mid-pronated. The ruler will be stabilized vertically by the examiner while the participants hold at the 5 cm with his/her web space (i.e. thumb and index finger). The participants will be asked to catch the ruler as fast as possible, after the ruler released from examiner's hand. The distance the ruler travelled from the starting point will be recorded as cm. This distance will be converted into time (sec) by using following formula "t =√(2d / g)".
Measured: baseline
Forward Head Posture
The severity of forward heaad posture will assessed with CROM device according to CROM Procedure Manual. Participants will instructed to sit erect posture with spine away from the chair and feet flat on the floor. The horizontal bar with measured will be placed on the head, the vertical bar, whose lower end will be positioned over the spinal process of the 7th cervical vertebra (C7). After the resting point, where the vertical bar will be on, will be noted, the participants will be instructed to retract their heads as possible. The displacement in the sagittal plane will be recorded in cm.
Measured: baseline
Proprioception
Joint position error (JPE) was measured to assess neck reposition sense of participants. For this test, the participants will be seated in chair with an erect posture, the examiner will stabilize the CROM device with the Velcro strap on participants head. They will be asked to focus a point on the wall as a feedback for neutral position. After the device will be calibrated to neutral position, the participants will perform an active left and right cervical rotation with eyes opened. This test will be repeated with eyes closed. The difference between reading values on the CROM device each side of rotation starting position and final position of the head (JPE) will be recorded as degree.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start5 Nov 2021
- Primary completion1 Sep 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internet Gaming DisorderStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aybike Senel, Istanbul University - Cerrahpasa
- Investigators
- Ebru KAYA MUTLU, PT, Assoc, Prof, Study director, İstanbul University-Cerrahpaşa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631523
- Sponsor's protocol ID
- 120
- Status last verified
- Mar 2024
- First submitted
- 2 Nov 2020
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Internet Gaming Disorder and Reaction Time, Motor Dexterity, Neck Posture and Proprioception in Adolescents
- ClinicalTrials.gov ID
- NCT04631523
- Acronym / sponsor ID
- 120
- Conditions
- Internet Gaming Disorder
- Keywords
- internet gaming disorder, fine motor skills, adolescent, sensorimotor function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 17 Nov 2020 (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.
Using computer for long have been shown to cause vision problems, musculoskeletal pain particularly in neck, postural deviations, obesity and physical inactivity in several studies. The relation between obesity and physical activity, neck pain and postural deviations with altered sensorimotor function has been also shown with many studies. However, there were not enough study that assess sensorimotor congruence such as proprioception and reaction time in adolescents diagnosed with Internet Gaming Disorder (IGD). This study aimed to evaluate the proprioception and reaction time and investigate its relation with the relationship with neck pain, proprioception and reaction time in adolescents with IGD.
Detailed description
The aim of this study is to evaluate reaction time, motor dexterity, cervical posture and proprioception and its relationship with Internet Gaming Disorder (IGD) in adolescents. It's anticipated that 60 adolescents aged between 10-18 years will be included to this study (30 healthy adolescent; 30 adolescent with IGD. After recording sociodemografic data of participants, age of starting to use the internet, the age of starting to play games on the internet, the time spent on the internet, the name and type of the game played will be questioned. The presence of musculoskeletal pain and its localization, if any, will be recorded. The severity of internet addiction will be assessed with Internet Addiction Scale, motor dexterity will be assessed with The 9 Hole Peg Test, reaction time of upper extremity will be assessed with Ruler Drop Method, the severity of forward head posture will be assessed with Cervical Range of Motion (CROM) device, and lastly, proprioception of cervical region will be assessed with Joint Position Error which will be evaluated CROM device. All parameters will be compared between healthy adolescents and adolescents with IGD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGD Group | – | –The eligibility criteria were for IGD group as follows: being male in age between 10-18 years old; having accepted the research on a voluntary basis and signed the informed consent and being diagnosed with IGD according to DSM-5. Healthy adolescents in this study will be referred from a child and adolescent psychiatrist. All the following assessments will be applied this group for one time; Internet Addiction Scale, 9 Hole Peg Test, Ruler Drop Method, assessment of Forward Head Posture, evaluation of Joint Position Error of cervical region. |
| Healthy Group | – | –The eligibility criteria were for healthy group as follows: being male in age between 10-18 years old and having accepted the research on a voluntary basis and signed the informed consent. The adolescents with IGD in this study will be referred from a child and adolescent psychiatrist. All the following assessments will be applied this group for one time; Internet Addiction Scale, 9 Hole Peg Test, Ruler Drop Method, assessment of Forward Head Posture, evaluation of Joint Position Error of cervical region. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This study will include 60 male adolescents diagnosed with Internet Gaming Disorder by the psychiatrist in Basaksehir Cam and Sakura City Hospital Child and Adolescent Psychiatry, Istanbul. The individuals who volunteers and meets the inclusion criteria will be included in the study.
Key inclusion criteria (4 listed)
- being male in age between 10-18 years old
- having accepted the research on a voluntary basis and signed the informed consent.
- For the experimental group, being diagnosed with IGD according to DSM-5 is an additional criterion.
Key exclusion criteria (3 listed)
- being diagnosed with psychotic, bipolar, or autism spectrum disorder
- the presence of mental retardation in the child or family that prevents answering the questions and following the instructions properly in clinical assessment
- Use of psychotropic drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Internet Addiction Scale
Time frame: baseline
It is a 20-itemed Likert type scale whose items are grading "Rarely", "Occasionally", "Often", "Most of the time" or "Always" with points of 1,2,3,4,5, respectively. The lowest score that can be obtained from the test is 20 and the highest score is 100. A score of 80 and above is an indicator of significant impairment in functionality and this group was defined as "internet addicted". Scores of "49 points and below" were defined as the "average internet user" who does not have any problems related to internet use in his life.
4 secondary outcomes
9 Hole Peg Test
Time frame: baseline
Ruler Drop Method
Time frame: baseline
Forward Head Posture
Time frame: baseline
Proprioception
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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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.
Ebru KAYA MUTLU, PT, Assoc, Prof study director
İstanbul University-Cerrahpaşa
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 Internet Gaming Disorder, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 15 Mar 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internet Addiction Scale (time frame: baseline). 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 15 Mar 2024.