Condition category
Not Applicable
Date applied
26/10/2019
Date assigned
29/10/2019
Last edited
08/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Anti-microbial resistance has reached alarming levels and considered to be a worldwide public health problem. One of the main significant contributing factors of AMR is the lack of sufficient knowledge of using antibiotics. Antibiotics are being used frequently in dentistry. Recent studies found games (such as board game) to have a promising way to improve knowledge in health and can be used to improve knowledge about anti-microbial resistance among people. This study tries to assess the effect of using a board game on anti-microbial resistance knowledge among the public in Saudi Arabia.

Who can participate?
In this study, female volunteers member from the department of Friends Association Charitable Society (FACS) in Makkah, Saudi Arabia, who speak Arabic, older than 18 years old, and agree to participate in the study and answer all the questionnaires

What does the study involve?
The intervention will test the board game and its effect on people’s knowledge of antimicrobial resistance. Volunteers were involved and were divided into two groups in a random way. The first group received information about AMR by playing a board game, while the second group received the same information given in a conventional lecture. The participants were evaluated three times: before the playing/ getting the lecture, immediately after that, and after one month.

What are the possible benefits and risks of participating?
A participant went to random prize draw to (50 Saudi Riyal) from a famous book store. No risks.

Where is the study run from?
Friends Association Charitable Society (FACS) in Makkah, Saudi Arabia

When is the study starting and how long is it expected to run for?
February 219 to April 2019

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Khalid Aboalshamat
ktaboalshsmat@uqu.edu.sa

Trial website

Contact information

Type

Scientific

Primary contact

Dr Khalid Aboalshamat

ORCID ID

http://orcid.org/0000-0001-5957-8681

Contact details

Umm Al-Qura University
Makkah
24352
Saudi Arabia
+966 (0)543536468
ktaboalshsmat@uqu.edu.sa

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

UQUDENT 120-19

Study information

Scientific title

The effect of gamification on antimicrobial resistance knowledge and its relation to dentistry in Saudi Arabia: RCT

Acronym

Study hypothesis

What is the effect of gamification as health promotion method on awareness level and information retention of anti-microbial resistance and its relation to dentistry in compared to conventional educational lecture method?

Ethics approval

Approved 20/01/2019, Umm Al-qura University, Faculty of dentistry IRB (Umm Al-Qura University, Makkah, 24352, Saudi Arabia; +966125270000; irb.uqudent@uqu.edu.sa), ref: 120-19

Study design

Randomized controlled trial single blind with active control group

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Other

Patient information sheet

See additional files

Condition

Knowledge of antimicrobial resistance

Intervention

Intervention group:
Participants in the study played (The Chancellor) board game, which is a custom-made educational board game. The game went to three rounds of pilot to tests until the final version to be used in the study. The game is between two players who try to finish ten steps in the gameboard before the opponent. The game composed of one board game, two piles of flashcards, two different pawns for each player, and a dice to decide who play first. At each turn, a player tries to move one step forward and the opponent tries to stop her to move by drawing a flashcard that contains a question about AMR, extra information about AMR, and/or funny challenge. The funny challenge is a request to do a specific task in each card such as saying the same information about AMR in a different accent or saying the information while the player holding his nose. If the player wins the challenge, she can move forward, otherwise, she stays at her place waiting for another turn. Each game takes around 20-30 minutes. Participants played the games in multiple sets of two players at the same time. For more detail about the game, you can contact the study authors. During the intervention, the game was supervised by the research team to explain and facilitate playing.

Control group:
The control group received a lecture titled “Antimicrobial resistance”. Composed of powerpoint presentation delivered by one of the research team in the Arabic Language. The content was the same as the intervention. The lecture was given in 20 minutes.

Randomization:
Randomization was conducted using simple randomization process of previously shuffled sealed envelopes by equal allocation ratio, using pieces of paper in a bowl, so each participant picked a piece randomly so she could be allocated with 50% chance into two comparative groups. To fulfil concealment of allocation, the sealed envelopes were opaque and numbered sequentially. This resulted in allocating participants into SG and CG. the To ensure blindness, the participants informed that the study aimed to compare between two methods of delivery to improve AMR knowledge. None of the participants was aware that gamification was the main aim of the study. Thus, the study was single-blind.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Total knowledge score of antimicrobial resistance at baseline, post-intervention, and one month

Secondary outcome measures

Participants opinion about the gamification as a method to improve awareness measured using a bespoke questionnaire after participation

Overall trial start date

26/09/2018

Overall trial end date

04/04/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Arabic speakers
2. Older than 18 years
3. Agree to participant in the intervention and answer all the questionnaires. All participants who did not agree to sign the consent form were excluded from the study

Participant type

Other

Age group

Adult

Gender

Female

Target number of participants

112

Participant exclusion criteria

Does not meet and fulfill inclusion criteria, or did not sign the study conset form.

Recruitment start date

01/02/2019

Recruitment end date

02/02/2019

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

Friends Association Charitable Society (FACS) in Makkah, Saudi Arabia
Alzaidi
Makkah
21955
Saudi Arabia

Sponsor information

Organisation

Umm Al-Qura University

Sponsor details

Al Abdeyah
Makkah
21955
Saudi Arabia
+966125501000
ktaboalshamat@uqu.edi.sa

Sponsor type

University/education

Website

http://www.uqu.edu.sa

Funders

Funder type

Other

Funder name

investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

The protocol has been uploaded as an additional file (not peer reviewed).

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Dr. Khalid Aboalshamat, Umm Al-Qura University, Faculty of Dentistry, Saudi Arabia.
SPSS file (unidentified)
The data will be available upon request for two years.
Data can be accessed by the journal to which we will submit our article, any Saudi Governmental authority, researchers after careful consideration of their scientific intention to use.
All data are anonymous with no identification

Intention to publish date

24/12/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/11/2019: The participant information sheet has been uploaded. Uploaded protocol 29 October 2019 (not peer reviewed). 29/10/2019: Trial’s existence confirmed by Umm Al-qura University, Faculty of dentistry IRB