- Designing a learning smartphone application
- Evaluating the effect of gamified features in effectiveness of training mothers about child oral health care
Design
Experimental trial or pretest-posttest control experimental group، single blind، randomized
Settings and conduct
A smartphone app for improving oral health in mothers and their children is compared with an enriched app with gamified features. The study will be conducted in the special clinic of the Faculty of Dentistry, Tehran University of medical science. Mothers will be assigned randomly, to either a simple app group or an enriched app with gamified features.Before receiving the app, mothers in both groups would fill up the knowledge of oral health and self-report practice questionnaire on oral health of the mother and the child. The modified microbial plaque index will be also examined and recorded on their children's teeth. After a month, the previous questionnaire will be filled out again by mothers.The plaque index will be evaluated. One researcher gives pre-test and post-test questionnaires to mothers and a second researcher performs statistical analysis.
Both researchers are blind to the allocation of participants to groups.
Participants/Inclusion and exclusion criteria
Inclusion: Mothers and their children under the age of 6 years
Inclusion:Mothers with smartphones, children under 6 tears old
Exclusion:Children who have systemic diseases.
Intervention groups
Control group:Mothers who receive a simple application
Case group:Mothers who receive an enriched app with gamified features
Main outcome variables
Change in knowledge, attitude and practice of mothers
Change in plaque index of baby
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131102015238N2
Registration date:2019-02-24, 1397/12/05
Registration timing:registered_while_recruiting
Last update:2019-02-24, 1397/12/05
Update count:0
Registration date
2019-02-24, 1397/12/05
Registrant information
Name
Simin Z. Mohebbi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5960
Email address
smohebbi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of gamified features in effectiveness of training mothers about child oral health care by smartphone application
Public title
Evaluating the effect of a mobile smartphone software in child oral health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers who have smart phone.
Children aged less than 6 years
Exclusion criteria:
Children who have systemic diseases
Age
From 1 year old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomisation method, using an Excel spreadsheet:
In the Excel spreadsheet the leftmost column shows the total number of participants, which in the current study will be 116.
The next column indicates the group to which participants belong, with the top half in Group A and the bottom half in Group B.
For the next column is filled using the" Rand() "function; this function generates random numbers for all individuals.
Finally, we arrange the random numbers in ascending order, so the individuals will be randomly ordered within each of the two groups.
Random unit: individual
Randomization Tool: Software
Blinding (investigator's opinion)
Single blinded
Blinding description
A person who gives pre-test and post-test questionnaires to mothers and the researcher who performs assessment and statistical analysis is blind to the allocation of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Number 2, Dolatshahi alley, Naderi street, Keshavarz Boulvar, Virtual faculty
City
Tehran
Province
Tehran
Postal code
1417614418
Approval date
2019-01-27, 1397/11/07
Ethics committee reference number
IR.TUMS.VCR.REC.1397.855
Health conditions studied
1
Description of health condition studied
Knowledge, attitude and practice of mothers regarding oral health
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Microbial plaque
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mother's score in knowledge, attitude, and practice questionnaire
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Knowledge, attitude and practice questionnaire on oral health
2
Description
Microbial Plaque
Timepoint
Before the intervention, one month after the intervention
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Mothers will receive an enriched app with gamified features for improving the oral health of mothers and their children. Participants will be followed-up one month after the first intervention.
Category
Lifestyle
2
Description
Control group: Mothers who receive a simple application.Participants will be follow upped one month after intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Simin Z. Mohebbi
Street address
End of North Kargar Street, Adjacent to the Atomic Energy Organization, High School of Dentistry, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
smohebbi@tums.ac.ir
Web page address
http://dentistry.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Keshavarz Blvd, Ghods St, Central Organization of the University, Sixth Department of Research and Technology
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir
Grant name
Tehran University of Medical Sciences, Research Deputy
Grant code / Reference number
40116
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Simin Z. Mohebbi
Position
Head of Community Oral Health Dept
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
End of Karger street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Fax
+98 21 8801 5961
Email
smohebbi@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Simin Z. Mohebbi
Position
Head of Community oral health Dept
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
End of Kargar Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Email
smohebbi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Simin Z. Mohebbi
Position
Head of Community Oral Health Dept
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
End of Kargar street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Email
smohebbi@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
We are going to publish a paper from the study findings and all above mentioned may be included in appendix or sent to journal for public view
When the data will become available and for how long
We are going to publish a paper from the study findings and all above mentioned may be included in appendix or sent to journal for public view
To whom data/document is available
We are going to publish a paper from the study findings and all above mentioned may be included in appendix or sent to journal for public view
Under which criteria data/document could be used
We are going to publish a paper from the study findings and all above mentioned may be included in appendix or sent to journal for public view.
From where data/document is obtainable
We are going to publish a paper from the study findings and all above mentioned may be included in appendix or sent to journal for public view
What processes are involved for a request to access data/document
We are going to publish a paper from the study findings and all above mentioned may be included in appendix or sent to journal for public view
Comments
We are going to publish a paper from the study findings and all above mentioned may be included in appendix or sent to journal for public view.