Protocol summary

Summary
This study is an intervention with the aim of educational effects specification based on oral health behaviors in patients with type 2 diabetes. The study population; are patients with diabetes type2 under cover of diabetes clinic of Kashan's Matini Hospital. The sample content is of 120 people. The samples were selected randomly (draw) in the intervention and control groups (Each group;60 individual). Inclusion criteria: patients who are covered by clinic; 40 to 60 years old and literate; without artificial teeth and oral disease; without recent radiotherapy and dialysis; using dry mouth drugs is avoided. Exclusion Criteria: Patient's unwillingness to continue the participation in the study; absence of more than 2 session. This study was designed based on the health belief model and it'll be done by this process: Samples were selected and divided into two groups of control and intervention; Pre-test questionnaire; Educational intervention in4 sessions or more according to the needs; 60 minutes of intervention group about the anatomy of mouth and teeth; the impact of diabetes on oral health; signs and symptoms of oral disease; brushing and flossing correctly and gum massages; the impact of diet and exercise on diabetes treatment based on health belief model for intervention in a month; only the control group will receive the routine clinic training; perform post-test questionnaire 3 months after the intervention; analyzing and comparing information. The main variable outcome is the performance of diabetic patient.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050733847N1
Registration date: 2017-06-14, 1396/03/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-06-14, 1396/03/24
Registrant information
Name
Maryam MalekMahmoodi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5543 0515
Email address
m.malekmahmoudi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Supplied by Vice President Of Research; Arak University of Medical Science
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-08-06, 1396/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining educational effect based on health belief model on the improving of the oral health treatments of patients with type 2 diabetes.
Public title
Effect of education based on health belief model on the improving of the oral health
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: it will be contacted with literate patients who have the record in diabetes clinic in order to study on their patient file. Moreover; in case of satisfaction and being interested in the subject; they will be able to register for studying. Being literate; living in Kashan; aged 40 to 60 years Owning the file at station; not having oral disease including gingivitis; infections of the oral cavity or tooth damage; lack of history of radiation therapy. (During radiotherapy (radiation) In case the entered radiation to neck and head influences the salivary glands; it will lead to disorder in salivating). In addition the patients who receive hemodialysis; they will be faced with dry mouth (Xerostomia) by virtue of limitation in consuming liquids amount or taking drugs with side effects of dry mouth (such as antidepressants; antihistamines and decongestants; antidiarrheal medications; muscle relaxant; drugs for high blood pressure; urinary inconvenience; the ones for Parkinson disease; AIDS and diabetes can cause dry mouth in individuals.No artificial teeth; not being under medical supervision and patients with lack of advanced dental disease based on information contained in the file. Exclusion Criteria: patient's unwillingness to continue the participation in the study; absence of more than 2sessions.
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Basij square;Pardis Educational Complex Department of Education and Research; Arak
City
Arak
Postal code
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.ARAKMU.REC.1395.444

Health conditions studied

1

Description of health condition studied
Oral Dieaseas
ICD-10 code
k05
ICD-10 code description
Gingivitis and periodontal diseases

Primary outcomes

1

Description
Oral health behavior's promotion
Timepoint
Before and three month after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
The structural health belief model score(allergy ;intensity; benefits and barriers; cues to action and efficacy.
Timepoint
Before and three months after intervention
Method of measurement
Questionnaire

2

Description
Secondary outcomes 2 :performance score of the oral health behavior's promotion
Timepoint
Before and three months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention2: only the control group will receive the routine diabetes clinic training.
Category
Behavior

2

Description
Intervention 1: Education based on health belief model in intervention group for 4 educational sessions according to the needs; 1 hour via lecture and discussion using training manual and etc. with data collection through questionnaire or interview before and 3 months after the intervention
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Kashan's Matini Hospital
Full name of responsible person
Malekmahmoodi Maryam
Street address
Amir kabire street; Matini hospital; Kashan
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice President of Research;Arak University of Medical Science.
Full name of responsible person
Dr.Ali Anoshirvani; Vice President of Research
Street address
Basij square ; Campus Educational Complex; Deputy Education and Research
City
ََArak
Grant name
1711
Grant code / Reference number
1711
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research;Arak University of Medical Science.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mohsen Shamsi
Position
Phd in Education and Health Promotion; Faculty of Arak University of Medical Science.
Other areas of specialty/work
Street address
Mustafa Khomein Street; School of Health; Arak
City
Arak
Postal code
38181-4-6851
Phone
+98 86 3368 6443
Fax
Email
mohsen_shamsi1360@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
ِِDr. Mohsen Shamsi
Position
PHD Associate Professor
Other areas of specialty/work
Street address
Mustafa Khomeini Street; School of Health; Arak
City
Arak
Postal code
38181-4-6851
Phone
+98 86 3368 6443
Fax
Email
mohsen_shamsi1360@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Maryam Malekmahmoodi
Position
Master of Science Student.
Other areas of specialty/work
Street address
Mustafa Khomeini Street; school of Health ; Arak
City
Arak
Postal code
38181-4-6851
Phone
+98 86 3368 6443
Fax
Email
malekmahmoodi.ma@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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