COVID-19NCT05377931
Ocular and Cardiac Effects of Battle Ground
An observational study of COVID-19 and Accommodation Spasm, run by Benha University at 1 site in Egypt.
Trial summary
Mobile battle ground games are widely used in various age groups, there are ocular and cardiac affection that may affect users of this type of action games. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- COVID-19, Accommodation Spasm, Tachycardia
- What is being tested?
- Changes in heart pulse rate and Changes in eye strain
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2022to 20 Feb 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 18 to 40 years
- All sexes
- Adult
Study population: Subjects that are using action mobile games during their leisure and are members of faculty of medicine, Banha university and are seeking to participate in this study.
Who may be able to join
- Normal subjects that are playing or not playing action mobile battle ground games will be included.
- Post COVID-19 subjects with average 6 months of infection and are playing mobile battle. Ground games will be included.
Who cannot join
- Subjects that refuse to enter the study.
- Users of mobile battle ground games with other diseases that may affect ocular and cardiac assessment as diabetic eye disease, cardiac congenital anomalies or recent cardiac or ocular surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abdelshafy
Banhā, QA, 13511
Ahmed Abdelshafy, MD, 01222328766, ahmad4lg@gmail.com
Marwa Abdelshafy, MD, 01222328766, ahmad4lg@gmail.com
About this study
Official title: Ocular and Cardiac Effects of Mobile Battle Ground Games
Mobile battle ground games are widely used in various age groups, there are ocular and cardiac affection that may affect users of this type of action games.
Read the detailed description
The aim of this study is to assess the possible ocular and cardiac changes that may affect users of this type of mobile games in real life among various age groups and especially in adults with history of recent corona virus (COVID-19) disease. There is no medical recommendations about the time and the hazards of using this games for longer periods in real practice.
- Conditions
- COVID-19, Accommodation Spasm, Tachycardia, Stress Reaction, Cardiac Arrhythmia
- Being tested
- Changes in heart pulse rate, Changes in eye strain
- Keywords
- Battle ground games, Accommodation, Spasm, Eye strain, Pulse disorder, Tachycardia
- Medical subject headings
- COVID-19, Spasm, Tachycardia, Fractures, Stress, Arrhythmias, Cardiac, Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changes in heart pulse rateDiagnostic test
Also called Pulse oximeter changes
Measuring heart pulse rate using a wrest smart watch.
Changes in eye strainDiagnostic test
Changes in Accommodation measured by auto refractometer before and after mobile battle ground gaming.
| Study group | Role | What they receive |
|---|---|---|
| Normal subjects users of battle ground games (Group 1) | Subjects with no history of any medical diseases that are using mobile battle ground games for average 2 hours per day. Receives: Diagnostic Test: Changes in heart pulse rate; Diagnostic Test: Changes in eye strain | |
| Post COVID-19 users of battle ground games (Group 2) | Adults with a recent history of COVID-19 (average of 6 months after onset of the disease) that returned to their normal life style and are using mobile battle ground games. Receives: Diagnostic Test: Changes in heart pulse rate; Diagnostic Test: Changes in eye strain | |
| Normal subjects not playing mobile games (Groups 3) | Normal subjects that are not using any action mobile games. Receives: Diagnostic Test: Changes in heart pulse rate; Diagnostic Test: Changes in eye strain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in heart pulse rate
Changes in pulse in each group members measured by smart wrest watch in pulse beat/per minute.
Measured: During playing mobile battle ground games
Secondary outcomes (1)
Changes in accommodation
Changes in eye accommodation measured by auto refractometer in diopter (D).
Measured: Before and immediately after mobile battle ground games
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start10 May 2022
- Primary completion10 Feb 2023 (estimated)
- Study completion20 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Benha UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Mohamed A Abdelshafy, MD, Study chair, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377931
- Sponsor's protocol ID
- RC 10-22
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular and Cardiac Effects of Mobile Battle Ground Games
- ClinicalTrials.gov ID
- NCT05377931
- Acronym / sponsor ID
- RC 10-22
- Conditions
- COVID-19, Accommodation Spasm, Tachycardia, Stress Reaction, Cardiac Arrhythmia
- Keywords
- Battle ground games, Accommodation, Spasm, Eye strain, Pulse disorder, Tachycardia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 10 Feb 2023 (estimated)
- Study completion
- 20 Feb 2023 (estimated)
- First posted
- 17 May 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.
Mobile battle ground games are widely used in various age groups, there are ocular and cardiac affection that may affect users of this type of action games.
Detailed description
The aim of this study is to assess the possible ocular and cardiac changes that may affect users of this type of mobile games in real life among various age groups and especially in adults with history of recent corona virus (COVID-19) disease. There is no medical recommendations about the time and the hazards of using this games for longer periods in real practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal subjects users of battle ground games (Group 1) | – | Diagnostic Test: Changes in heart pulse rate, Diagnostic Test: Changes in eye strainSubjects with no history of any medical diseases that are using mobile battle ground games for average 2 hours per day. |
| Post COVID-19 users of battle ground games (Group 2) | – | Diagnostic Test: Changes in heart pulse rate, Diagnostic Test: Changes in eye strainAdults with a recent history of COVID-19 (average of 6 months after onset of the disease) that returned to their normal life style and are using mobile battle ground games. |
| Normal subjects not playing mobile games (Groups 3) | – | Diagnostic Test: Changes in heart pulse rate, Diagnostic Test: Changes in eye strainNormal subjects that are not using any action mobile games. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- Subjects that are using action mobile games during their leisure and are members of faculty of medicine, Banha university and are seeking to participate in this study.
Key inclusion criteria (2 listed)
- Normal subjects that are playing or not playing action mobile battle ground games will be included.
- Post COVID-19 subjects with average 6 months of infection and are playing mobile battle. Ground games will be included.
Key exclusion criteria (2 listed)
- Subjects that refuse to enter the study.
- Users of mobile battle ground games with other diseases that may affect ocular and cardiac assessment as diabetic eye disease, cardiac congenital anomalies or recent cardiac or ocular surgery.
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 |
|---|---|---|
| Changes in heart pulse rateAlso: Pulse oximeter changesMeasuring heart pulse rate using a wrest smart watch. | Diagnostic test | Normal subjects not playing mobile games (Groups 3), Normal subjects users of battle ground games (Group 1), Post COVID-19 users of battle ground games (Group 2) |
| Changes in eye strainChanges in Accommodation measured by auto refractometer before and after mobile battle ground gaming. | Diagnostic test | Normal subjects not playing mobile games (Groups 3), Normal subjects users of battle ground games (Group 1), Post COVID-19 users of battle ground games (Group 2) |
Primary outcome
Changes in heart pulse rate
Time frame: During playing mobile battle ground games
Changes in pulse in each group members measured by smart wrest watch in pulse beat/per minute.
1 secondary outcome
Changes in accommodation
Time frame: Before and immediately after mobile battle ground games
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 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.
Mohamed A Abdelshafy, MD study chair
Benha 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 COVID-19 and Accommodation Spasm, run by Benha 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 2 inclusion and 2 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 17 May 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 Ahmed Abdelshafy, MD (01222328766, ahmad4lg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in heart pulse rate (time frame: During playing mobile battle ground games). 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 17 May 2022.