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Designing, Implementing and Evaluating the Effect of Educational Intervention Program Using Combination of Health Belief Model and Theory of Planned Behavioral on Mammography in Women Referring to Khorramabad Health Centers

Protocol summary

Study aim
Design, implementation and evaluation of the effect of educational intervention program based on health belief model and theory of planned behavior on performing mammography in women referring to Khorram Abad health centers
Design
Clinical trials with randomized control group, with parallel group, randomized
Settings and conduct
The present study was an Interventional and experimental study. A randomized sampling method was performed on 140 women aged 50-70 years who referred to Khorramabad health centers in two groups of control and control.
Participants/Inclusion and exclusion criteria
inclusion criteria: Being in the age group of 50 to 70 years; Having no history of breast cancer in one person or first-degree relatives (sister, mother, daughter) - Not having a history of mammography over the past year Exclusion criteria: Unwillingness to cooperate; No participation in training sessions more than two sessions; No participation in post-test
Intervention groups
In the intervention group, the sessions were lecture, group discussion and question and answer sessions, based on the results of the pre-test and not presented in control group
Main outcome variables
Performing Mammography,perceived sensinvity, perceived severity,perceived barriers, perceived benefits,self-efficacy, motivationfor health, cues to action, attittude,normative belief, perceived behavior control, intention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190407043188N1
Registration date: 2019-06-19, 1398/03/29
Registration timing: retrospective

Last update: 2019-06-19, 1398/03/29
Update count: 0
Registration date
2019-06-19, 1398/03/29
Registrant information
Name
zahra khazir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9114
Email address
zahrakhazir@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2018-12-01, 1397/09/10
Actual recruitment start date
2018-06-20, 1397/03/30
Actual recruitment end date
2019-03-06, 1397/12/15
Trial completion date
2019-03-06, 1397/12/15
Scientific title
Designing, Implementing and Evaluating the Effect of Educational Intervention Program Using Combination of Health Belief Model and Theory of Planned Behavioral on Mammography in Women Referring to Khorramabad Health Centers
Public title
The effect of educational intervention program on performing mammography in women referring to health centers
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
Having ages 50 to 70 years old Not having a mammogram history over the past year Not having a history of breast cancer in one person or first-degree relatives (sister, mother, daughter)
Exclusion criteria:
Unwillingness to cooperate No participation in training sessions more than two sessions No participation in training sessions more than two sessions No participation in post-test
Age
From 50 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
Actual sample size reached: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Cluster sampling was done on 140 women who referred to health centers in two groups of control and control. Therefore,Four centers were randomly selected and 35 of them each randomly entered the study
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
Ethic committee of Shahid Sadoughi University of Medical Sciences
Street address
Yazd University of Medical Sciences,Safayee St,Alem Square,
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2017-01-25, 1395/11/06
Ethics committee reference number
IR.SSU.SPH.REC.1395.134

Health conditions studied

1

Description of health condition studied
The effect of educational intervention program using combination of health belief model and theory of planned behavior on performing mammography in women referring to health centers
ICD-10 code
Z12.3
ICD-10 code description
Special screening examination for neoplasm of breast

Primary outcomes

1

Description
perform of mammography
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
Questionnaire

2

Description
perceived Sensitivity and severity
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
Questionnaire

3

Description
perceived Benefits
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
Questionnaire

4

Description
perceived Barriers
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
Questionnaire

5

Description
perceived Self-efficacy
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
Questionnaire

6

Description
Cues to action
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
Questionnaire

7

Description
Attitude
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
Questionnaire

8

Description
Normative beliefs
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
Questionnaire

9

Description
Perceived behavioral control
Timepoint
Before the intervention and 3 months after the end of the intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Using the results of the pre-test, the training classes were considered for this group
Category
Early detection

2

Description
Control group: There was no intervention for this group. After the collection of post-test information, they were given pamphlets and educational booklet
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center of Army Alley
Full name of responsible person
Zahra Hasanvand
Street address
Golestan Saadi Avenue 10, Health Center of Army Alley
City
Khorramabad
Province
Lorestan
Postal code
6816959436
Phone
+98 66 3320 9115
Email
zahrakhazir@gmail.com

2

Recruitment center
Name of recruitment center
Health Center of Farzanegan Alley
Full name of responsible person
Khatoon Paknejad
Street address
Sajjad YA60 meter high street, Shahid Nademi Blvd, 1th Farzanegan Alley
City
Khorramabad
Province
Lorestan
Postal code
6819863133
Phone
+98 66 3323 3894
Email
Zahrakhazir@gmail.com

3

Recruitment center
Name of recruitment center
Somaye Health Center
Full name of responsible person
Hoda Delavar
Street address
Shaghayegh Avenue, kazemian Alley
City
Khorramabad
Province
Lorestan
Postal code
6814639519
Phone
+98 66 3343 1089
Email
Zahrakhazir@gmail.com

4

Recruitment center
Name of recruitment center
Hosseinabad Poshteh Health Center
Full name of responsible person
Shahla Beyranvandi
Street address
Tayeb Avenue, 3th Pakdasht Alley
City
Khorramabad
Province
Lorestan
Postal code
6818916546
Phone
+98 66 3340 0790
Email
ZahraKhazir@Gmail.Com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Masood Mirzaie
Street address
Yazd University of Medical Sciences, Alem Square, Safayee St.,
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9114
Email
zahrakhazir@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Zahra khazir
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Yazd University of Medical Sciences, Safayee St.,Alem Square
City
Khorramabad
Province
Lorestan
Postal code
8915173160
Phone
+98 35 3820 9114
Email
zahrakhazir@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
zahra khazir
Position
Ph.D. student health education and promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Yazd University of Medical Sciences., safaieh Ave., Alem Square
City
khorramabad
Province
Lorestan
Postal code
8915173160
Phone
+98 35 3820 9100
Email
zahrakhazir@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
zahra khazir
Position
Ph.D. student health education and promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Yazd University of Medical Sciences., Safaieh Ave., Alem Square
City
Khorramabad
Province
Lorestan
Postal code
8915173160
Phone
+98 35 3820 9100
Email
zahrakhazir@gmail.com

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
Not applicable
Title and more details about the data/document
All data, including data before intervention and after intervention
When the data will become available and for how long
Start the access period 3 months after printing the results
To whom data/document is available
Researchers and people working in health centers
Under which criteria data/document could be used
Any use subject to the mention of the source is authorized
From where data/document is obtainable
email
What processes are involved for a request to access data/document
It is sent about 21 days after requesting data
Comments
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