Determining the Effect of Peer Education on Women's Self-efficacy in Breast Implantation
Design
A community-based control-controlled clinical trial with randomized, double-blind, randomized, factorial groups.
Settings and conduct
An interventional study was conducted in Dehloran city. Exit participants and evaluators were blinded.
They did not know they were compared to the other group.
Control and intervention groups were located in two different cities, and the groups were not related.
Participants/Inclusion and exclusion criteria
Entry requirements included the absence of a history of breast cancer in the participant and first-degree family members, having reading and writing skills, the absence of a disease or any disability that makes the study difficult, and the conditions for withdrawal The lack of participation in two sessions of the educational program and failure to complete the questionnaire.
Intervention groups
The intervention group was trained in breast self-examination.
The control group did not receive any training.
Main outcome variables
Breast self-examination, peer education, self-efficacy
General information
Reason for update
Acronym
.
IRCT registration information
IRCT registration number:IRCT20181001041194N1
Registration date:2018-12-23, 1397/10/02
Registration timing:retrospective
Last update:2018-12-23, 1397/10/02
Update count:0
Registration date
2018-12-23, 1397/10/02
Registrant information
Name
Kazemieh Sadeghirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3372 9535
Email address
sadeghirad.ka@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Peer Education on self-efficacy of Breast Self-Examination(BSE) in woman
Public title
The effect of Peer Education on self-efficacy of Breast Self-Examination(BSE) in woman
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The absence of a history of breast cancer in a person participating in research and first-degree family
MembersHaving reading and writing
SkillsLack of illness or any disability that makes the study difficult.
Exclusion criteria:
Not attending two sessions of the training program.
Failure to complete the questionnaire.
Age
From 25 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Using a lottery, eight centers of the two centers were selected.
From the two selected centers, using a lottery, a center was assigned for the intervention group and one center for the control group.
A random number table method was used to select individuals in each center.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants did not know that their results would be compared to one another.
The peer ladies who were responsible for assessing the outcome of the study were unaware that their results would be compared to one another.
In the random selection of centers, two centers from two different cities were selected for study.
The groups were not connected.
Placebo
Not used
Assignment
Factorial
Other design features
.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-02-25, 1396/12/06
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9311690006
Health conditions studied
1
Description of health condition studied
Effect of training on self-efficacy in BSE
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
self-efficacy
Timepoint
Before the intervention and one month after the intervention is completed.
Method of measurement
Use of self-efficacy section in "Champion questionnaire".
Secondary outcomes
1
Description
Breast self-examination
Timepoint
Before the intervention and one month after the intervention.
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Four sessions per hour (including two sessions of theoretical education and two practical training sessions) were presented to the participants during the four consecutive weeks in the form of group discussions, lectures and demonstrations.
Category
Prevention
2
Description
The Control group did not receive any intervention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dehloran Health Care Network
Full name of responsible person
Dr. Asadollah Mohajer
Street address
Dehloran Health Care Network, Jomhoori Street, Dehloran City
City
Dehloran
Province
Ilam
Postal code
6981615431
Phone
+98 84 3372 9608
Email
k.sadeghi1388@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Kazem Malakoti
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Fax
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Miss, Marhamat Frahaninia
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Valiasr St., Above the Vanak Square, Rashid Yasemi Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1806
Email
mary_f2008@yahoo.ca
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Miss Marhamat Frahaninia
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Valiasr St., Above the Vanak Square, Rashid Yasemi Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1806
Email
mary_f2008@yahoo.ca
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazmieh Sadeghirad
Position
collegian
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr St., Above the Vanak Square, Rashid Yasemi Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1806
Email
k.sadeghi1388@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD