Comparison of the effect of face-to-face and social network-based education based on the health belief model on model structures and breast self-examination behavior of women
Comparison of the effect of face-to-face and social network-based education based on the health belief model on model structures and breast self-examination behavior
Design
Clinical trial with a control group; two intervention groups, parallel groups; double-blind; randomized by random allocation method and permutation blocks in 9 blocks of 18
Settings and conduct
Comprehensive health centers of Shiraz; intervention with face-to-face and virtual training; double blinding of the participants in the study and data analyst
Participants/Inclusion and exclusion criteria
participants; all women referring to the selected comprehensive health centers of Shiraz; Entry criteria; Women aged 18 to 50 years; Having literacy and the ability to work with a smart phone and informed consent to participate in the research; Absence of breast diseases in the past and present; Not having a history of participating in a training class on breast screening; Exit criteria; Moving people's residences; Absence of more than one meeting in the face-to-face group; Not seeing the messages uploaded by people in the social network-based group and not sending a confirmation message; Failure to answer more than 20% of the questions in each of the questionnaires before and after the intervention
Intervention groups
Education about breast cancer and prevention methods is based on the health belief model in the intervention group based on social networks in a virtual form and in the face-to-face education group. After teaching each part based on the structure of the model, the questions related to it are provided to the people. The control group will also receive common services from comprehensive health centers.
Main outcome variables
perceived sensitivity and severity of breast cancer; perceived benefits and barriers of breast self-examination; Efficacy; health motivation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160404027216N11
Registration date:2024-02-15, 1402/11/26
Registration timing:prospective
Last update:2024-02-15, 1402/11/26
Update count:0
Registration date
2024-02-15, 1402/11/26
Registrant information
Name
Fatemeh Vizeshfar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4258
Email address
vizeshfarf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-05-04, 1403/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of face-to-face and social network-based education based on the health belief model on model structures and breast self-examination behavior of women
Public title
Comparison of the effect of face-to-face and social network-based education based on the health belief model on model structures and breast self-examination behavior of women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with a minimum age of 18 and a maximum age of 50 years
Having literacy and the ability to work with a smart phone
Having informed consent to participate in the research
Absence of breast diseases in the past and present
Not having a history of participating in a training class on breast screening
Exclusion criteria:
Moving people's place of residence
Absence of more than one session of people present in the face-to-face training intervention group
Failure to see the messages uploaded by the people in the social network-based intervention group and failure to send confirmation messages by them
Failure to answer more than 20% of the questions in each of the questionnaires before and after the intervention
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
159
Randomization (investigator's opinion)
Randomized
Randomization description
3 comprehensive health centers were selected by a simple random method from among 32 comprehensive health centers in Shiraz city, and after referring and coordinating with the relevant officials of the centers, women with entry criteria will be determined based on active cases in the Sib system, and then the samples will be contacted by phone. . The conditions of the research have been explained to the subjects and if they have consent, they will be entered into each of the intervention and control groups by random allocation method and permutation block method in 9 blocks of 18; Otherwise, according to the table of random numbers, the sample will be added to complete the number of 53 people in each center.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants will be contacted separately and will enter the study, and the people of each group will be unaware of the existence of the other two groups.
The data is provided to the data analyst in the form of three groups, and he is unaware of the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Namazi Square, Faculty of Nursing and Midwifery of Hazrat Fatemeh
City
Shiraz
Province
Fars
Postal code
13119–71936
Approval date
2024-02-04, 1402/11/15
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.131
Health conditions studied
1
Description of health condition studied
Constructs of health belief model related to breast cancer (Champion's Health Belief Model)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Perceived susceptibility score of breast cancer in Champion Health Belief Model Questionnaire
Timepoint
Before the intervention, immediately after the intervention, 2 months after the intervention
Method of measurement
Champion Health Belief Model Questionnaire
2
Description
Perceived severity score of breast cancer in Champion Health Belief Model Questionnaire
Timepoint
Before the intervention, immediately after the intervention, 2 months after the intervention
Method of measurement
Champion Health Belief Model Questionnaire
3
Description
The score of the perceived benefits of breast self-examination in the Champion Health Belief Model Questionnaire
Timepoint
Before the intervention, immediately after the intervention, 2 months after the intervention
Method of measurement
Champion Health Belief Model Questionnaire
4
Description
The score of perceived barriers to breast self-examination in the Champion Health Belief Model Questionnaire
Timepoint
Before the intervention, immediately after the intervention, 2 months after the intervention
Method of measurement
Champion Health Belief Model Questionnaire
5
Description
Self-efficacy score of breast self-examination in Champion health belief model questionnaire
Timepoint
Before the intervention, immediately after the intervention, 2 months after the intervention
Method of measurement
Champion Health Belief Model Questionnaire
6
Description
Health motivation score in Champion Health Belief Model Questionnaire
Timepoint
Before the intervention, immediately after the intervention, 2 months after the intervention
Method of measurement
Champion Health Belief Model Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The participants in the study will first complete the informed consent form and the demographic information questionnaire and the Champion Health Belief Model through a virtual link sent to their mobile phone or in person.The people present in the face-to-face training group (based on the available facilities and the conditions of the face-to-face training group are divided into several smaller groups) also undergo face-to-face training about breast cancer and prevention methods based on the health belief model along with questions and answers, during six sessions - 60 30 minutes will be arranged; In this way, in the first session, after explaining the objectives and completing the questionnaire in person, the trainings related to the perceived sensitivity part and the second session of the perceived intensity will be presented and the questionnaire related to these two parts will be provided to the people. In the third session, the trainings related to the perceived benefits of self-examination, the fourth session, presentation of content and brainstorming among members about the perceived obstacles of self-examination, and finally, the fifth and sixth sessions will be presented on how and when to perform self-examination to increase self-efficacy in women. At the end of each session, people's questions are answered and the questionnaire related to the presented part is given to the women to complete. Then, two months after the intervention, the link of the aforementioned questionnaire will be sent again to the participants in the social network-based training group and the control group, and if they do not complete the questionnaire, they will be followed up through text messages and phone calls; The people present in the face-to-face group will also complete the questionnaire in person. In order to comply with the ethical codes, after completing the study, the educational content in the form of a pamphlet is provided to the control group.
Category
Other
2
Description
Intervention group: The participants in the study will first complete the informed consent form and the demographic information questionnaire and the Champion Health Belief Model through a virtual link sent to their mobile phone or in person.First, in coordination with the women of the virtual training group, one of the software agreed upon by all the groups is installed on their mobile phones and a group is formed on the social network, then the people in the training group based on social networks, after completing the questionnaires, are trained virtually for 6 stage and will be placed once every two days. For this purpose, health and educational messages are based on the health belief model, which includes statistics related to the incidence of disease, risk factors in the development of disease, prevention and screening methods, and how to perform breast self-examination in six stages, in the form of text, video and photos compiled by the researcher. And based on the materials and sources approved by the Ministry of Health, it will be sent to them, and after studying each section, they will be requested to send a message confirming the study to the researcher. A time will be set aside after each stage, with the agreement of the people in this group, to respond online to possible questions and ambiguities after each stage, and the researcher will answer them. Then the link to the questions related to that part of the model structure will be sent to them for completion. Then, two months after the intervention, the link of the aforementioned questionnaire will be sent again to the participants in the social network-based training group and the control group, and if they do not complete the questionnaire, they will be followed up through text messages and phone calls; The people present in the face-to-face group will also complete the questionnaire in person. In order to comply with the ethical codes, after completing the study, the educational content in the form of a pamphlet is provided to the control group.
Category
Other
3
Description
Control group: The participants in the study will first complete the informed consent form and the demographic information questionnaire and the Champion Health Belief Model through a virtual link sent to their mobile phone or in person.The control group will also receive common services and training from comprehensive health centers, and at the same time as they complete the questionnaire immediately after the intervention, they will also be provided with the link to complete the questionnaire.Then, two months after the intervention, the link of the aforementioned questionnaire will be sent again to the participants in the social network-based training group and the control group, and if they do not complete the questionnaire, they will be followed up through text messages and phone calls; The people present in the face-to-face group will also complete the questionnaire in person. In order to comply with the ethical codes, after completing the study, the educational content in the form of a pamphlet is provided to the control group. Then, two months after the intervention, the link of the aforementioned questionnaire will be sent again to the participants in the social network-based training group and the control group, and if they do not complete the questionnaire, they will be followed up through text messages and phone calls; The people present in the face-to-face group will also complete the questionnaire in person. In order to comply with the ethical codes, after completing the study, the educational content in the form of a pamphlet is provided to the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health centers in the city of Shiraz