Protocol summary

Study aim
Determining the effectiveness of face-to-face and virtual training based on the theory of planned behavior on breast self-examination
Design
In this randomized controlled clinical trial, 240 women were randomly assigned to three groups of 80 people in face-to-face, virtual, and control groups. The random sequence of people in the intervention or control groups was done through block building with a ratio of 1:1.
Settings and conduct
Women aged 30-55 referring to comprehensive urban and rural health centers of Babol University of Medical Sciences are selected as available, then their knowledge and practice are measured with a knowledge questionnaire and a practice observation form. Each of the women whose knowledge and practice scores are weak are included in the study. Women who meet the criteria for entering the study are randomly assigned to three groups: face-to-face intervention, virtual intervention, and control.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 30-55 years At least fifth-grade education Iranian race Poor knowledge and practice score A resident of Babol city Willingness to participate in the study Exclusion criteria: Average and strong knowledge and practice score Pregnancy and breastfeeding at the time of study History of benign and malignant breast cancer in the individual and in first-degree relatives Health care workers People with health-related education Migration
Intervention groups
Breast self-examination training based on the theory of planned behavior was held in groups in four consecutive 50-minute weekly sessions for face-to-face and virtual training groups (three theory sessions and one practical training session). The control group did not receive any intervention.
Main outcome variables
Attitude, Normative, Perceived behavioral control, Behavioral intention, Behavior, knowledge, Practice

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230130057274N4
Registration date: 2024-04-29, 1403/02/10
Registration timing: retrospective

Last update: 2024-04-29, 1403/02/10
Update count: 0
Registration date
2024-04-29, 1403/02/10
Registrant information
Name
Hajar Adib-Rad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
adibrad2015@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
2020-06-21, 1399/04/01
Actual recruitment end date
2022-03-20, 1400/12/29
Trial completion date
2022-03-20, 1400/12/29
Scientific title
The effectiveness of of face-to-face and virtual education on the theory of planned behavior on breast self-examination: A randomized clinical trial study
Public title
The effectiveness of face-to-face and virtual education on the theory of planned behavior on breast self-examination
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30-55 years At least fifth grade education Iranian race Poor knowledge and practice score A resident of Babol city Willingness to participate in the study
Exclusion criteria:
Average and strong knowledge and practice score Pregnancy and breastfeeding at the time of study History of benign and malignant breast cancer in the individual and in first degree relatives Health care workers People with health related education Migration
Age
From 30 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 240
Actual sample size reached: 240
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects are randomly divided into three groups after applying the entry and exit criteria in the form of random allocation using the alternative block method. The size of the blocks is six, and six blocks will be produced 40 times using the statistical software. Considering that sampling is done in eight centers, a sample list of 240 items will be produced. Using this randomly generated list, the participants are assigned to three groups of 80 people in face-to-face, virtual, and control groups. The random sequence of people in the intervention or control groups is done through block building with a ratio of 1:1, and the researcher cannot predict the placement of the next person in any of the two groups.
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
Health Research Institute - Babol University of Medical Sciences (Research Ethics Committee)
Street address
Ganj Afrooz St., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2020-05-31, 1399/03/11
Ethics committee reference number
IR.MUBABOL.HRI.REC.1399.208

Health conditions studied

1

Description of health condition studied
-
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Attitude structure
Timepoint
Before the intervention, one and three months after the end of the intervention
Method of measurement
Breast self-examination questionnaire based on the theory of planned behavior (attitude)

2

Description
Normative structure
Timepoint
Before the intervention, one and three months after the end of the intervention
Method of measurement
Breast self-examination questionnaire based on the theory of planned behavior (normative)

3

Description
The construct of perceived behavioral control
Timepoint
Before the intervention, one and three months after the end of the intervention
Method of measurement
Breast self-examination questionnaire based on the theory of planned behavior ( perceived behavioral control)

4

Description
The construct of behavioral intention
Timepoint
Before the intervention, one and three months after the end of the intervention
Method of measurement
Breast self-examination questionnaire based on the theory of planned behavior ( behavioral intention)

5

Description
Behavior structure
Timepoint
Before the intervention, one and three months after the end of the intervention
Method of measurement
Breast self-examination questionnaire based on the theory of planned behavior ( behavioral )

Secondary outcomes

1

Description
Women's knowledge about breast self-examination
Timepoint
Before the intervention, one and three months after the end of the intervention
Method of measurement
Researcher-made knowledge questionnaire about breast self-examination

2

Description
Women's practice about breast self-examination
Timepoint
Before the intervention, one and three months after the end of the intervention
Method of measurement
Breast self-examination practice observation form

Intervention groups

1

Description
Intervention group: Breast self-examination training based on the theory of planned behavior was held in groups in four consecutive 50-minute weekly sessions for face-to-face training groups (three theory sessions and one practical training session). The contents of the sessions include: the first session: based on the attitude structure, the second session: based on the mental norm structure, the third session: based on the perceived behavior control structure, the fourth session: based on the behavioral intention structure and breast self-examination behavior
Category
Behavior

2

Description
Intervention group: Breast self-examination training based on the theory of planned behavior was held in groups in four consecutive weekly sessions of 50 minutes for virtual training groups (three theory sessions and one practical training session). The contents of the sessions include: the first session: based on the attitude structure, the second session: based on the mental norm structure, the third session: based on the perceived behavior control structure, the fourth session: based on the behavioral intention structure and breast self-examination behavior
Category
Behavior

3

Description
Control group: This group of women does not receive the intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive urban and rural health centers of the University of Medical Sciences
Full name of responsible person
Hajar Adib-Rad
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
Adibrad2015@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajab Nia
Street address
Vice-Chancellor's Office for Research, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4720
Email
ramazan69@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
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
Babol University of Medical Sciences
Full name of responsible person
Hajar Adib-Rad
Position
Faculty member - Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
Adibrad2015@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hajar Adib-Rad
Position
Faculty member - Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
Adibrad2015@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hajar Adib-Rad
Position
Faculty member - Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
Adibrad2015@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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