Knowledge of Infection ControlNCT06402227
Effectiveness of Board Game on Improving Elementary School Students' Infection Control
A study testing gamified instruction and conventional lesson lecture in people with Knowledge of Infection Control and Attitude of Infection Control, run by HU, HUEY-LAN at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to learn if board game can improve elementary school students' infection control intentions. The investigators use the theory of planned behavior (TPB), which includes three main factors: attitude, subjective norm, and perceived behavioral control. Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Knowledge of Infection Control, Attitude of Infection Control, Behavioral Intentions of Infection Control
- What is being tested?
- gamified instruction and conventional lesson lecture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2023to 30 Mar 2024
- Phase
- Interventional
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students in fifth to sixth grade of the elementary school (10 to 13 years old) and their legal representatives must fill in the informed consent form.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Board Game on Improving Knowledge, Attitudes and Behavioral Intentions of Infection Control for Senior Elementary School Students: a Randomized Controlled Trial
The goal of this clinical trial is to learn if board game can improve elementary school students' infection control intentions. The investigators use the theory of planned behavior (TPB), which includes three main factors: attitude, subjective norm, and perceived behavioral control. The main questions it aims to answer are:
- Exploring the factors influencing children's behavioral intentions of infection control through theory of planned behavior?
- The effectiveness of board game on improving children's knowledge and behavioral intentions of infection control?
Read more
Researchers will compare gamified instruction to conventional lesson lecture to see if the former has better results.
Students who participated in filled out the questionnaire three times, each time taking about 15 to 20 minutes: before the intervention, after the intervention, and after a one-month delay. The students' legal representatives filled out a basic demographic questionnaire before intervention, which took about 5 minutes.
After a one-month delay, two groups of students were asked to filled out the post-test questionnaire again. Then, students in the control group were invited to participate in a board game and asked which teaching method they preferred (gamified instruction or conventional lesson lecture).
- Conditions
- Knowledge of Infection Control, Attitude of Infection Control, Behavioral Intentions of Infection Control
- Being tested
- gamified instruction, conventional lesson lecture
- Keywords
- Gamification, Child, Communicable Diseases, Theory of Planned Behavior
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gamified instructionOther
At the beginning, the speaker played the role of a laboratory rescue team, narrated the background story of the board game, and led the children into the game situation. Then, the speaker explained four types of pathogens, which the investigators defined them according to different types of transmission, including droplets, airborne, blood or body fluids, and fecal-oral. The speaker explained their characteristics and key points, representative diseases in real life, corresponding prevention methods and so on. The lecture lasted for 15 minutes, then the children were divided into different groups to play the board game for about 20 minutes. During the game, students were required to collect "Prevention Method Cards" made by the research team. Students must perform the correct behavior of infection control or answer questions related to the class content in order to obtain the card and win.
conventional lesson lectureOther
The lecture was about 35 minutes. At the beginning, the speaker explained the terms to children, including infectious diseases, symptoms and pathogens. Next, the speaker introduced the components of the infection chain and how to make infection control behaviors for different parts of it. Then the speaker focused on the four types of transmission, including droplets, airborne, blood or body fluids, and fecal-oral. The speaker illustrated their characteristics and key points, representative diseases in real life, and corresponding prevention methods. In the end, the speaker led the students to practice infection control behaviors, such as the seven correct steps of washing hands, the right steps for wearing and taking off masks, and exercises that can be done to increase immunity.
| Study group | Role | What they receive |
|---|---|---|
| gamified instruction | Experimental | Not described Receives: Other: gamified instruction |
| conventional lesson lecture | Other | Not described Receives: Other: conventional lesson lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
intention to infection control behavior
Theory of planned behavior guided questionnaire (S-CVI/UA=0.962, S-CVI/Ave=0.992) was developed to exam students' attitude, subjective norm, and perceived behavioral control toward infection control behavior over time (pre-intervention, post-intervention, and 4 weeks after intervention). A Likert 5-point scale was used in the TPB questionnaire, the higher the score, the higher the intention for infection control behavior.
Measured: baseline, the day receiving the intervention, a one-month delay after the intervention.
knowledge of infection control
A self-developed knowledge questionnaire (S-CVI/UA=0.8, S-CVI/Ave=0.96) which has fifteen multiple choices questions was used to evaluate students' infection control knowledge over time (pre-intervention, post-intervention, and 4 weeks after intervention). The higher the score, the more positive the outcome.
Measured: baseline, the day receiving the intervention, a one-month delay after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Nov 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Knowledge of Infection ControlStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators randomly divided students' classes into the experimental group and the control group. The former received gamified instruction, while the latter received conventional lesson lecture. After a one-month delay, students in the control group were invited to participate in the board game.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- HU, HUEY-LAN
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council
- Responsible party
- Sponsor-investigator, HU, HUEY-LAN, National Yang Ming Chiao Tung University
- Investigators
- HUEY-LAN HU, professor, Study chair, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402227
- Sponsor's protocol ID
- NYCU112151AEF
- Status last verified
- May 2024
- First submitted
- 6 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baker RE, Mahmud AS, Miller IF, Rajeev M, Rasambainarivo F, Rice BL, Takahashi S, Tatem AJ, Wagner CE, Wang LF, Wesolowski A, Metcalf CJE. Infectious disease in an era of global change. Nat Rev Microbiol. 2022 Apr;20(4):193-205. doi: 10.1038/s41579-021-00639-z. Epub 2021 Oct 13.
PubMed 34646006Wang X, Wang S, Wang J, Rong L. A Multiscale Model of COVID-19 Dynamics. Bull Math Biol. 2022 Aug 9;84(9):99. doi: 10.1007/s11538-022-01058-8.
PubMed 35943625Li DJ, Ko NY, Chang YP, Yen CF, Chen YL. Mediating Effects of Risk Perception on Association between Social Support and Coping with COVID-19: An Online Survey. Int J Environ Res Public Health. 2021 Feb 6;18(4):1550. doi: 10.3390/ijerph18041550.
PubMed 33561974Cheng HC, Chang YJ, Liao SR, Siewchaisakul P, Chen SL. The impact of COVID-19 on knowledge, attitude, and infection control behaviors among dentists. BMC Oral Health. 2021 Nov 19;21(1):584. doi: 10.1186/s12903-021-01946-w.
PubMed 34798843Ajzen I. The theory of planned behavior. Organizational Behavior and Human Decision Processes. 1991; 50 (2): 179-211.
Luxi N, Giovanazzi A, Capuano A, Crisafulli S, Cutroneo PM, Fantini MP, Ferrajolo C, Moretti U, Poluzzi E, Raschi E, Ravaldi C, Reno C, Tuccori M, Vannacci A, Zanoni G, Trifiro G; Ilmiovaccino COVID19 collaborating group. COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety. Drug Saf. 2021 Dec;44(12):1247-1269. doi: 10.1007/s40264-021-01131-6. Epub 2021 Nov 5.
PubMed 34739716Frenck RW Jr, Klein NP, Kitchin N, Gurtman A, Absalon J, Lockhart S, Perez JL, Walter EB, Senders S, Bailey R, Swanson KA, Ma H, Xu X, Koury K, Kalina WV, Cooper D, Jennings T, Brandon DM, Thomas SJ, Tureci O, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. N Engl J Med. 2021 Jul 15;385(3):239-250. doi: 10.1056/NEJMoa2107456. Epub 2021 May 27.
PubMed 34043894Wang M, Han X, Fang H, Xu C, Lin X, Xia S, Yu W, He J, Jiang S, Tao H. Impact of Health Education on Knowledge and Behaviors toward Infectious Diseases among Students in Gansu Province, China. Biomed Res Int. 2018 Mar 7;2018:6397340. doi: 10.1155/2018/6397340. eCollection 2018.
PubMed 29707573Silva MT, Galvao TF, Chapman E, da Silva EN, Barreto JOM. Dissemination interventions to improve healthcare workers' adherence with infection prevention and control guidelines: a systematic review and meta-analysis. Implement Sci. 2021 Oct 24;16(1):92. doi: 10.1186/s13012-021-01164-6.
PubMed 34689810Alhumaid S, Al Mutair A, Al Alawi Z, Alsuliman M, Ahmed GY, Rabaan AA, Al-Tawfiq JA, Al-Omari A. Knowledge of infection prevention and control among healthcare workers and factors influencing compliance: a systematic review. Antimicrob Resist Infect Control. 2021 Jun 3;10(1):86. doi: 10.1186/s13756-021-00957-0.
PubMed 34082822McCoy L, Lewis JH, Dalton D. Gamification and Multimedia for Medical Education: A Landscape Review. J Am Osteopath Assoc. 2016 Jan;116(1):22-34. doi: 10.7556/jaoa.2016.003.
PubMed 26745561Sardi L, Idri A, Fernandez-Aleman JL. A systematic review of gamification in e-Health. J Biomed Inform. 2017 Jul;71:31-48. doi: 10.1016/j.jbi.2017.05.011. Epub 2017 May 20.
PubMed 28536062Guan X, Sun C, Hwang G, Xue K, Wang Z. Applying game-based learning in primary education: a systematic review of journal publications from 2010 to 2020. Interactive Learning Environments. 2022; null 1-23.
de Graaf M, Beck R, Caccio SM, Duim B, Fraaij P, Le Guyader FS, Lecuit M, Le Pendu J, de Wit E, Schultsz C. Sustained fecal-oral human-to-human transmission following a zoonotic event. Curr Opin Virol. 2017 Feb;22:1-6. doi: 10.1016/j.coviro.2016.11.001. Epub 2016 Nov 23.
PubMed 27888698Wolfe ND, Dunavan CP, Diamond J. Origins of major human infectious diseases. Nature. 2007 May 17;447(7142):279-83. doi: 10.1038/nature05775.
PubMed 17507975
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Board Game on Improving Knowledge, Attitudes and Behavioral Intentions of Infection Control for Senior Elementary School Students: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06402227
- Acronym / sponsor ID
- NYCU112151AEF
- Conditions
- Knowledge of Infection Control, Attitude of Infection Control, Behavioral Intentions of Infection Control
- Keywords
- Gamification, Child, Communicable Diseases, Theory of Planned Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- HU, HUEY-LANUniversity, hospital or other
- Collaborators
- National Science and Technology Council
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 7 May 2024 (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 goal of this clinical trial is to learn if board game can improve elementary school students' infection control intentions. The investigators use the theory of planned behavior (TPB), which includes three main factors: attitude, subjective norm, and perceived behavioral control. The main questions it aims to answer are:
- Exploring the factors influencing children's behavioral intentions of infection control through theory of planned behavior?
- The effectiveness of board game on improving children's knowledge and behavioral intentions of infection control?
Researchers will compare gamified instruction to conventional lesson lecture to see if the former has better results.
Students who participated in filled out the questionnaire three times, each time taking about 15 to 20 minutes: before the intervention, after the intervention, and after a one-month delay. The students' legal representatives filled out a basic demographic questionnaire before intervention, which took about 5 minutes.
After a one-month delay, two groups of students were asked to filled out the post-test questionnaire again. Then, students in the control group were invited to participate in a board game and asked which teaching method they preferred (gamified instruction or conventional lesson lecture).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The investigators randomly divided students' classes into the experimental group and the control group. The former received gamified instruction, while the latter received conventional lesson lecture. After a one-month delay, students in the control group were invited to participate in the board game.
| Arm | Type | Receives |
|---|---|---|
| gamified instruction | Experimental | Other: gamified instruction |
| conventional lesson lecture | Other | Other: conventional lesson lecture |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students in fifth to sixth grade of the elementary school (10 to 13 years old) and their legal representatives must fill in the informed consent form.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| gamified instructionAt the beginning, the speaker played the role of a laboratory rescue team, narrated the background story of the board game, and led the children into the game situation. Then, the speaker explained four types of pathogens, which the investigators defined them according to different types of transmission, including droplets, airborne, blood or body fluids, and fecal-oral. The speaker explained their characteristics and key points, representative diseases in real life, corresponding prevention methods and so on. The lecture lasted for 15 minutes, then the children were divided into different groups to play the board game for about 20 minutes. During the game, students were required to collect "Prevention Method Cards" made by the research team. Students must perform the correct behavior of infection control or answer questions related to the class content in order to obtain the card and win. | Other | gamified instruction |
| conventional lesson lectureThe lecture was about 35 minutes. At the beginning, the speaker explained the terms to children, including infectious diseases, symptoms and pathogens. Next, the speaker introduced the components of the infection chain and how to make infection control behaviors for different parts of it. Then the speaker focused on the four types of transmission, including droplets, airborne, blood or body fluids, and fecal-oral. The speaker illustrated their characteristics and key points, representative diseases in real life, and corresponding prevention methods. In the end, the speaker led the students to practice infection control behaviors, such as the seven correct steps of washing hands, the right steps for wearing and taking off masks, and exercises that can be done to increase immunity. | Other | conventional lesson lecture |
Primary outcome
intention to infection control behavior
Time frame: baseline, the day receiving the intervention, a one-month delay after the intervention.
Theory of planned behavior guided questionnaire (S-CVI/UA=0.962, S-CVI/Ave=0.992) was developed to exam students' attitude, subjective norm, and perceived behavioral control toward infection control behavior over time (pre-intervention, post-intervention, and 4 weeks after intervention). A Likert 5-point scale was used in the TPB questionnaire, the higher the score, the higher the intention for infection control behavior.
knowledge of infection control
Time frame: baseline, the day receiving the intervention, a one-month delay after the intervention.
A self-developed knowledge questionnaire (S-CVI/UA=0.8, S-CVI/Ave=0.96) which has fifteen multiple choices questions was used to evaluate students' infection control knowledge over time (pre-intervention, post-intervention, and 4 weeks after intervention). The higher the score, the more positive the outcome.
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 7 May 2024.
- Background: PubMed 34646006Baker RE, Mahmud AS, Miller IF, Rajeev M, Rasambainarivo F, Rice BL, Takahashi S, Tatem AJ, Wagner CE, Wang LF, Wesolowski A, Metcalf CJE. Infectious disease in an era of global change. Nat Rev Microbiol. 2022 Apr;20(4):193-205. doi: 10.1038/s41579-021-00639-z. Epub 2021 Oct 13.
- Background: PubMed 35943625Wang X, Wang S, Wang J, Rong L. A Multiscale Model of COVID-19 Dynamics. Bull Math Biol. 2022 Aug 9;84(9):99. doi: 10.1007/s11538-022-01058-8.
- Background: PubMed 33561974Li DJ, Ko NY, Chang YP, Yen CF, Chen YL. Mediating Effects of Risk Perception on Association between Social Support and Coping with COVID-19: An Online Survey. Int J Environ Res Public Health. 2021 Feb 6;18(4):1550. doi: 10.3390/ijerph18041550.
- Background: PubMed 34798843Cheng HC, Chang YJ, Liao SR, Siewchaisakul P, Chen SL. The impact of COVID-19 on knowledge, attitude, and infection control behaviors among dentists. BMC Oral Health. 2021 Nov 19;21(1):584. doi: 10.1186/s12903-021-01946-w.
- BackgroundAjzen I. The theory of planned behavior. Organizational Behavior and Human Decision Processes. 1991; 50 (2): 179-211.
- Background: PubMed 34739716Luxi N, Giovanazzi A, Capuano A, Crisafulli S, Cutroneo PM, Fantini MP, Ferrajolo C, Moretti U, Poluzzi E, Raschi E, Ravaldi C, Reno C, Tuccori M, Vannacci A, Zanoni G, Trifiro G; Ilmiovaccino COVID19 collaborating group. COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety. Drug Saf. 2021 Dec;44(12):1247-1269. doi: 10.1007/s40264-021-01131-6. Epub 2021 Nov 5.
- Background: PubMed 34043894Frenck RW Jr, Klein NP, Kitchin N, Gurtman A, Absalon J, Lockhart S, Perez JL, Walter EB, Senders S, Bailey R, Swanson KA, Ma H, Xu X, Koury K, Kalina WV, Cooper D, Jennings T, Brandon DM, Thomas SJ, Tureci O, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. N Engl J Med. 2021 Jul 15;385(3):239-250. doi: 10.1056/NEJMoa2107456. Epub 2021 May 27.
- Background: PubMed 29707573Wang M, Han X, Fang H, Xu C, Lin X, Xia S, Yu W, He J, Jiang S, Tao H. Impact of Health Education on Knowledge and Behaviors toward Infectious Diseases among Students in Gansu Province, China. Biomed Res Int. 2018 Mar 7;2018:6397340. doi: 10.1155/2018/6397340. eCollection 2018.
- Background: PubMed 34689810Silva MT, Galvao TF, Chapman E, da Silva EN, Barreto JOM. Dissemination interventions to improve healthcare workers' adherence with infection prevention and control guidelines: a systematic review and meta-analysis. Implement Sci. 2021 Oct 24;16(1):92. doi: 10.1186/s13012-021-01164-6.
- Background: PubMed 34082822Alhumaid S, Al Mutair A, Al Alawi Z, Alsuliman M, Ahmed GY, Rabaan AA, Al-Tawfiq JA, Al-Omari A. Knowledge of infection prevention and control among healthcare workers and factors influencing compliance: a systematic review. Antimicrob Resist Infect Control. 2021 Jun 3;10(1):86. doi: 10.1186/s13756-021-00957-0.
- Background: PubMed 26745561McCoy L, Lewis JH, Dalton D. Gamification and Multimedia for Medical Education: A Landscape Review. J Am Osteopath Assoc. 2016 Jan;116(1):22-34. doi: 10.7556/jaoa.2016.003.
- Background: PubMed 28536062Sardi L, Idri A, Fernandez-Aleman JL. A systematic review of gamification in e-Health. J Biomed Inform. 2017 Jul;71:31-48. doi: 10.1016/j.jbi.2017.05.011. Epub 2017 May 20.
- Introduction to the chain of infectionLink provided by the sponsor.
- Introduction to the Theory of Planed BehaviorLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
HUEY-LAN HU, professor study chair
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gamified instruction and conventional lesson lecture in people with Knowledge of Infection Control and Attitude of Infection Control, run by HU, HUEY-LAN at 1 site in Taiwan.
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 1 inclusion and 1 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 7 May 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 Taiwan. 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?
intention to infection control behavior (time frame: baseline, the day receiving the intervention, a one-month delay after the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06402227, which also lists 31 linked publications.
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 7 May 2024.