Effectiveness of Board Game on Improving Elementary School Students' Infection Control

May 2, 2024 updated by: HU, HUEY-LAN

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:

  1. Exploring the factors influencing children's behavioral intentions of infection control through theory of planned behavior?
  2. 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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
310

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • National Yang Ming University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: gamified instruction
Other: gamified instruction
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.
Other: conventional lesson lecture
Other: conventional lesson lecture
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, the day receiving the intervention, a one-month delay after the intervention.
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.
baseline, the day receiving the intervention, a one-month delay after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HU, HUEY-LAN

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Science and Technology Council

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: HUEY-LAN HU, professor, National Yang Ming University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NYCU112151AEF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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