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Evaluation of educational program based on PRECEDE-PROCEED model on professional skills of midwives and promotion of breast cancer control behavior in women

Protocol summary

Study aim
the effect of educational program based on the PRECEDE / PROCEED model on professional skills of midwives and promotion of breast cancer control behavior in women in Kabul city.
Design
This protocol is a clinical trial with a single-blind control group and runs in two steps. To randomly allocate midwives to randomized quadrilateral blocks, interventional and control groups are used. For each intervention and control group, 45 people were recruited. In the women's group, 200 are in the intervention group and 200 in the control group.
Settings and conduct
Implementation of training program for midwives: ‬‬‬‬ Designed training programs will be implemented through workshops with 15 participants in 3 groups for 3 days. Training sessions for midwives participating in the intervention group will be held at the Women's Health Center. Women's Training Stage: This section will be conducted by trained midwives from the first stage. Study of a blinded (female participants)
Participants/Inclusion and exclusion criteria
Including criteria for first stage (Midwives): 1. Employed at one of the private and public hospitals in Kabul city. 2. Have not completed the course before, according to the research unit. 3. Have a tendency to participate in the project. Including criteria for second stage (Women): 1. Be Between the ages of 20-64. 2. Strong tendency to attend a classroom. 3. Be residents of Kabul. 4. Do not have breast cancer. Exclusion criteria: having one of the types of existing cancers or having pathologic specimens suspected of breast cancer as documented during the study.
Intervention groups
Midwives and women in Kabul city community
Main outcome variables
Promoting the professional development of midwifery professionals through the development of an educational program will help in the form of a workshop for midwives, and if progress is made, it will be conducted throughout Afghanistan.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151228025743N2
Registration date: 2020-04-23, 1399/02/04
Registration timing: retrospective

Last update: 2020-04-23, 1399/02/04
Update count: 0
Registration date
2020-04-23, 1399/02/04
Registrant information
Name
Nesa Mohammadi
Name of organization / entity
Tarbiat Modares Univercity
Country
Iran (Islamic Republic of)
Phone
+98 21 7637 4667
Email address
n-mohammadi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of educational program based on PRECEDE-PROCEED model on professional skills of midwives and promotion of breast cancer control behavior in women
Public title
Evaluation of educational program based on PRECEDE-PROCEED model on professional skills of midwives and promotion of breast cancer control behavior in women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Including criteria for first stage (Midwives):1. Employed at one of the private and public hospitals in Kabul city. 2. Have not completed the course before, according to the research unit. 3. Have a tendency to participate in the project.Including criteria for second stage (Women): 1. Be Between the ages of 20-64. 2. Strong tendency to attend a classroom. 3. Be residents of Kabul. 4. Do not have breast cancer.
Exclusion criteria:
Exclusion criteria: having one of the types of existing cancers or having pathologic specimens suspected of breast cancer as documented during the study.
Age
From 20 years old to 64 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly allocate midwives to randomized quadrilateral blocks, interventional and control groups are used. Thus, blocks AABB, ABAA, ABBA, BABA, BBAA, BAAB are written on 6 cards and since the sample size of 90 midwives is estimated, 23 times randomly extracted from a card of one card and replaced by a replacement method Repeating. The extracted words are followed by a written statement and placed in 90 closed envelopes. Then the midwives are numbered from 1 to 90, and the first envelope, the second envelope, and the second, are divided into individuals. To randomly assign women to Kabul urban community, randomly assigned quadrilateral blocks are used to intervene and control groups. Thus, blocks AABB, ABAA, ABBA, BABA, BBAA, BAAB are written on 6 cards, and since the sample size is 400 women, 100 times randomly extracted from a card of one card and replaced by a repeat replacement method we do. The letters extracted are followed by a single letter and enclosed in 400 closed envelopes. Then the women are numbered from 1 to 400, and the first envelope, the second envelope, and the second, are divided into individuals.
Blinding (investigator's opinion)
Single blinded
Blinding description
just the participant will be informed about how the people will be placed in the intervention and control group
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University of Medical Sciences
Street address
Tehran, Jalal Al Ahmad highway, Beside to Shariati Hospital, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
3976171664
Approval date
2017-09-19, 1396/06/28
Ethics committee reference number
IR.TMU.REC.1396.618

Health conditions studied

1

Description of health condition studied
Evaluation of educational program based on PRECEDE-PROCEED model on professional skills of midwives and promotion of breast cancer control behavior in women of Kabul city community.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
determining the effect of educational program based on the PRECEDE / PROCEED model on professional skills of midwives and promotion of breast cancer control behavior in women in Kabul city.
Timepoint
oct 2018 - APR2019
Method of measurement
The method of data collection in all stages of the study is using the following questionnaires. Researcher-made questionnaire on demographic and fertility variables, Midwifery practical skill checklist, Chmpion standard health questionnaire, Knowledge standard questionnaire, Self-efficacy standard questionnaire, Researcher-made checklist for women self-examination self observation, Self-report self-report self-report form of breast self-examination.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Implementation of training program for midwives: ‬‬‬‬Designed training programs will be implemented through workshops with 15 participants in 3 groups for 3 days. Training sessions for midwives participating in the intervention group will be held at the Women's Health Center. Educational tools include educational slides, educational posters, moles for breast examination, and practical skills for breast examinations to improve practical skills for midwives. During the implementation of the workshop, interactive and question-and-answer training will take place. A complimentary pamphlet will be provided for them to read on their own. Before the intervention, the questionnaires and the checklist for the first stage of midwifery education will be completed in this section. After completing the training sessions again, the same questionnaires and a checklist of the midwives participating in the workshops will be evaluated.To determine the effectiveness of the Women's Health Support Center, the Focus Group will be discussed in each of the 3 groups of 15 midwives (intervention group).To determine the system efficiency, the Focus Group database will be discussed in each of the 3 groups of 15 midwives (intervention group).Women's Training Stage: This section will be conducted by trained midwives from the first stage. The midwives’ skills of breast examination will be double checked by a breast cancer specialist. Methodology: 400 women aged 20-64 years were selected and randomly assigned to intervention and control groups. In the intervention group 200 women and in the control group, 200 women will be included in the study. The method of women's education in the Focus Group and in the groups of 5 people will be taught and questioned by each trained midwife according to the curriculum. Before the intervention, the educational program of knowledge, belief, performance, health beliefs, self-efficacy and monthly self-report self-examination checklist of the breast were completed in this section (pre-test) and two months after the training again, the same questionnaires were provided to research units Placed and completed (post test). In order to encourage the participation in educational sessions for women, a researcher and midwife responsible for training the contact number and email will be provided to the intervention team for any questions.In relation to both control groups, no training is provided according to the program, and they receive only ordinary general education.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
مرکز حمایتی زنان
Full name of responsible person
نساء محمدی
Street address
The burned bridge, Kabul, Afghanistan
City
Kabul
Postal code
1001
Phone
+93 20 250 0522
Email
n-mohammadi@modares.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
دکتر مینور لمیعیان
Street address
Jalal Al-Ahmad Highway, beside to Shariati Hospital, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8822 0104
Email
n-mohammadi@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Tarbiat Modares
Proportion provided by this source
50
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
The University of Tarbiat Modares
Full name of responsible person
Minor Lamiyan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal Al-Ahmad Highway, beside to Shariati Hospital, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4673
Email
lamyianm@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Minor Lamyian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal Al-Ahmad Highway, next to Shariati Hospital, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4673
Email
lamyianm@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The university of Tarbiat Modares Medical Faculty
Full name of responsible person
nesa mohammadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Tehran, Jalal Al Ahmad highway, Beside to Shariati Hospital, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
3976171664
Phone
+98 21 7637 4534
Email
n-mohammadi@modares.ac.ir

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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