A Comparative study between the effect of Motivational Interviewing and common dental health education for mothers on the oral hygiene of under 6-year-old leukemic children
Comparison between the effect of Motivational Interviewing and common dental health education for mothers on the oral hygiene of under 6-year-old leukemic children
Design
randomized, blinded, controlled clinical trial with a parallel group design of 56 patients
Settings and conduct
Motivational Interviewing Method compares with common oral health teaching methods. The study is conducted in the MAHAK Pediatric Cancer Treatment & Research Center. Mothers are assigned randomly, to either common teaching methods group or Motivational Interviewing group. Before receiving the teaching method, with the help of the mothers of both groups, the knowledge, the attitude and practice questionnaire are completed. The microbial plaque index is also examined and recorded on children's teeth. After three months, the previous questionnaire is filled out again by mothers. The plaque index is 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 criteria:
Children under 6 years old;
Children on the primary stage of cancer and treated by chemotherapy;
Have consent for participation;
Mothers with minimum ability to read and write;
Mothers who are the main caregiver of the child in the family.
Exclusion criteria:
Children who have systemic diseases and intellectual disability;
children with acute Leukemia.
Intervention groups
Control group: Mothers who receive common teaching methods. Intervention group: Mothers who receive motivational interviewing protocol about child oral health.
Main outcome variables
Change in knowledge, attitude and practice of mothers. Change in plaque index of child.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131102015238N5
Registration date:2021-03-11, 1399/12/21
Registration timing:prospective
Last update:2021-03-11, 1399/12/21
Update count:0
Registration date
2021-03-11, 1399/12/21
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
2021-04-09, 1400/01/20
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative study between the effect of Motivational Interviewing and common dental health education for mothers on the oral hygiene of under 6-year-old leukemic children
Public title
Evaluating the effect of Motivational Interviewing in children with cancer oral hygiene and comparing with common teaching methods
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children under 6 years old.
Children on the primary stage of cancer and treated by chemotherapy
Have consent for participation
Mothers with minimum ability to read and write
Mothers who are the main caregiver of the child in the family.
Exclusion criteria:
Children who have systemic diseases and intellectual disability
Children with acute Leukemia
Age
To 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization 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 56. First we arrange the random numbers then in ascending order. 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, so the individuals will be randomly ordered within each of the two groups. At the end they enter the study according to the order of referral and allocate a code to them.
Random unit: individual Randomization Tool: Software
Blinding (investigator's opinion)
Double blinded
Blinding description
The information about the assignment of each participant to the study groups is coded and through this, the research facilitators, evaluators of the results and statistical analysts are blind to it.
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
2021-01-30, 1399/11/11
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1399.208
Health conditions studied
1
Description of health condition studied
oral hygiene of leukemic children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mother's score in knowledge, attitude, and practice questionnaire
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Knowledge, attitude and practice questionnaire on oral health
2
Description
Microbial Plaque
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mothers who receive motivational interviewing protocol about child oral health that Includes 5 stage and Dental Health Menu including information about oral health which mothers can choose any number of them. two phone call follow up appointment should be done two weeks and one month after intervention for answering questions.
Category
Lifestyle
2
Description
Control group: Mothers who receive common teaching method Including a pamphlet about oral health and a brief verbal explanation.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
MAHAK Pediatric Cancer Treatment & Research Center
Full name of responsible person
Simin Z. Mohebbi
Street address
MAHAK Pediatric Cancer Treatment & Research Center, MAHAK Blvd., Prof. Parvaneh Vossough St., Shahid Majdi Blvd., Artesh Freeway, Tehran – Iran
City
Tehran
Province
Tehran
Postal code
۱۹۵۶۹۹۳۴۶۱
Phone
+98 21 2350 1000
Email
smohebbi@tums.ac.ir
Web page address
https://mahak-charity.org/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Simin Z. Mohebbi
Street address
End of kargar Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5960
Email
smohebbi@tums.ac.ir
Web page address
Grant name
Grant code / Reference number
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
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
End of kargar Street
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+218 8015960
Fax
+98 21 8801 5961
Email
smohebbi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Simin Z. Mohebbi
Position
Faculty member
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
Fax
+98 21 8801 5961
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
Faculty member
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
Fax
+98 21 8801 5961
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
All the study findings will be shared after identifying people for public view in Tehran University of Medical Sciences program, Mahak hospital, and other cancer centers in Iran.
When the data will become available and for how long
The start of the data access period is 6 months after the results are published.
To whom data/document is available
All the study findings will be shared for public view in Tehran University of Medical Sciences program, Mahak hospital, and other cancer centers in Iran.
Under which criteria data/document could be used
.All the study findings could be used for improving children's oral health status in all cancer centers in Iran.
From where data/document is obtainable
Correspondent: Simin Z. Mohebbi
Email: smohebbi@tums.ac.ir
Phone: +218 8015960
What processes are involved for a request to access data/document