Protocol summary

Summary
This quasi-experimental study with two-group pre- and post-test design is conducted to determine the effects of the midwifery students' consultation and education on the referred mothers' attitudes toward delivery alternatives and the attitudes and skills of the referred women in breast self-examination in two health-care centers in Hamadan city, 2012. A center was randomly designated for experimental group sampling and another for the control ones. The study population includes all referred women/mothers to the research environments. 60 eligible primiparous women (n=30 in each experimental and control groups) and 60 non-pregnant women (n=30 in each experimental and control groups) are selected by convince sampling. in the first week of training, each group of midwifery students is prepared via the role-playing educational strategy to provide the counseling and education in the small group of mothers/women. Then, the counseling and educational intervention will be organized by these students for the small groups (maximum 6 participants) in the 2nd and 3rd weeks. All interventions will be done during two months. The research tools will be completed by interview/observation just before and after each counseling session in the experimental group and when the control ones come to clinic and before they leave it. The outcomes of this study are 1-the pregnant women's attitudes toward the delivery alternatives, 2-the women attitudes toward the BSE and 3-skills of the breast self exam.

General information

Acronym
NVD (Normal Vaginal Delivery) , SC (Cesarian section), BSE (Breast Self Exam)
IRCT registration information
IRCT registration number: IRCT201205269862N1
Registration date: 2012-07-06, 1391/04/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-07-06, 1391/04/16
Registrant information
Name
Mahnaz Khatiban
Name of organization / entity
Hamadabn University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0535
Email address
m-khatiban@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2012-04-04, 1391/01/16
Expected recruitment end date
2012-06-20, 1391/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of the midwifery students' counseling and education on the mothers' attitudes towards delivery alternatives and women's attitudes to and skill of BSE in Hamadan city's clinics 2012
Public title
The effects of the midwifery counseling on the Mothers' attitudes toward delivery alternatives and women's attitudes to and skill of BSE
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion Criteria for the first objective (to determine the effects of the education and counseling presented by midwifery students on the primipara pregnant women's attitudes toward delivery alternatives): The inclined women who are pregnant, primparous, with any physical and mental disease, in the last month of pregnancy. They have been undergoing routine prenatal care from at least 12 weeks of pregnancy. Inclusion Criteria for the 2nd and 3rd objectives (to determine the effects of the education and counseling presented by midwifery students on the women's attitudes to and skills of BSE): The inclined women who are not pregnant, with any physical and mental disease.
Age
No age limit
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
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
Hamadan University of Medical Sciences
Street address
Fahmideh Ave, Across the Mardom park
City
Hamadan
Postal code
Approval date
2012-06-11, 1391/03/22
Ethics committee reference number
1005/9/35/16/پ/د

Health conditions studied

1

Description of health condition studied
The pregnant women counselling about delivery alternatives by the midwifery students
ICD-10 code
Z71.9
ICD-10 code description
Counselling, unspecified

2

Description of health condition studied
The women counselling about self breast exam by the midwifery students
ICD-10 code
Z71.9
ICD-10 code description
Counselling, unspecified

3

Description of health condition studied
The education of the small group counseling method to the midwifery students via role-playing strategy
ICD-10 code
Z55.9
ICD-10 code description
Problem related to education and literacy, unspecified

Primary outcomes

1

Description
Women's attitudes towards BSE
Timepoint
Before and after the counseling session presented by midwifery students
Method of measurement
Questionnaire

2

Description
Pregnant women's attitudes to the delivery alternatives
Timepoint
Before and after the counseling session presented by midwifery students
Method of measurement
Questionnaire

3

Description
Women's skills in BSE
Timepoint
Before and after the counseling session presented by midwifery students
Method of measurement
Observational Checklist

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention: The midwifery students are going to be prepared to hold up the sessions of an small group counseling and education via role-playing strategy
Category
Behavior

2

Description
Intervention: the prepared midwifery students are going to present the delivery alternatives education and counseling to the primipara pregnant women in Imam Clinic./Control: the primipara pregnant women who are got routine counseling and education by personnel in the Shohada Clinic.
Category
Behavior

3

Description
Intervention: the prepared midwifery students are going to present the BSE education and counseling to the women in Imam Clinic./Control: the women who are got routine counseling and education by personnel in the Shohada Clinic.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Clinic- Hamadan University of Medical Sciences
Full name of responsible person
Mahnaz Khatiban
Street address
Sadaf St.
City
Hamadan

2

Recruitment center
Name of recruitment center
Shohada Clinic- Hamadan University of Medical Sciences
Full name of responsible person
Mahnaz Khatiban
Street address
Takhti St.
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Haydar Tavilani
Street address
Fahmideh Ave. across te Mardom Park-Hamadan Medical Sciences University, Vice-Chancellor for Research & Technology
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mahnaz Khatiban
Position
PhD
Other areas of specialty/work
Street address
Hamadan
City
Hamadan
Postal code
Phone
+98 81 1838 0150
Fax
Email
m-khatiban@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mahnaz Khatiban
Position
PhD
Other areas of specialty/work
Street address
Hamadan
City
Hamadan
Postal code
Phone
+98 81 1838 0150
Fax
Email
m-khatiban@umsha.ac.ir; mahnaz.khatiban@gmail.com; mkhnurse@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mahnaz.Khatiban
Position
PhD
Other areas of specialty/work
Street address
Hamadan
City
Hamadan
Postal code
Phone
+98 81 1838 0150
Fax
Email
m-khatiban@umsha.ac.ir; mahnaz.khatiban@gmail.com; mkhnurse@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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