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The effect of motivational interviewing on attitude, self-efficacy and decision about type of delivery in primigravid women requesting elective cesarean section referring to comprehensive health services centers

Protocol summary

Study aim
determine the effect of motivational interview on attitude, self-efficacy and decision about type of delivery in primigravid women requesting elective cesarean section referring to comprehensive health services centers of Zahedan in 1397
Design
The samples are selected by multistage sampling method. First, health centers of Zahedan are divided into 5 groups (clusters), including north, south, east, west, and center. Then, from each of the mentioned five districts, two centers are randomly chosen according to the required sample size. Again in the second clusters, one center is chosen as the intervention and the other as the control group; subsequently, 120 subjects satisfying the inclusion criteria are chosen by drawing and assigned to the groups.
Settings and conduct
The place of study is the health centers of Zahedan. How to conduct a motivational interviewing group counseling session during four 90 minute sessions of two sessions.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:1- Normal pregnancy between 28-31weeks 2- Do not receive education prior to entering the study Exit criteria: 1-history of acute or chronic cardiovascular diseases and systemic disease 2- have indication for emergency cesarean
Intervention groups
The intervention group will provide motivational interviewing group counseling sessions in four sessions of 90 minutes a week, two sessions at the clinic and at agreed time with women in groups of 5 to 10 people. The control group will only receive routine pregnancy training.
Main outcome variables
attitude in relation to type of delivery, childbirth self-efficacy, decision-making in relation to type of delivery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150727023370N5
Registration date: 2018-12-13, 1397/09/22
Registration timing: registered_while_recruiting

Last update: 2018-12-13, 1397/09/22
Update count: 0
Registration date
2018-12-13, 1397/09/22
Registrant information
Name
Maryam Navaee
Name of organization / entity
Nursing and Midwifery Faculty
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 4510
Email address
navaee.m@zamuc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-21, 1397/08/30
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of motivational interviewing on attitude, self-efficacy and decision about type of delivery in primigravid women requesting elective cesarean section referring to comprehensive health services centers
Public title
The effect of motivational interviewing on attitude, self-efficacy and decision about type of delivery in primigravid women requesting elective cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Normal pregnancy between 28-31weeks Ages 18 to 35 Normal fetus condition and amniotic fluid volume Singleton pregnancy Maternal body mass index in the normal range (25 >BMI >18.5) At least a fifth-grade of elementry education Do not receive education prior to entering the study Cephalic presentation
Exclusion criteria:
history of infertility history of acute or chronic cardiovascular diseases and systemic disease have indication for emergency cesarean
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
First, two centers located in each of the five districts of Zahedan are randomly selected. In the second clusters, one center is chosen as the intervention and the other as control group by drawing. The names of groups are designated as A (motivational interview) and B (control group) on two sheets, and the names of centers are written on two other sheets as A and B and put in another bag. Then, one sheet is chosen from each bag by drawing, and the first selected center is thus assigned to the first group and the remaining center in each cluster is assigned to the other group.
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
Ethic's committee of Zahedan University of Medical Sciences
Street address
Dr hesabi's Square، Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Approval date
2018-10-23, 1397/08/01
Ethics committee reference number
ir.zaums.rec.1397.294

Health conditions studied

1

Description of health condition studied
attitude and self efficacy and decision-making
ICD-10 code
Z55.9
ICD-10 code description
Problems related to education and literacy, unspecified

2

Description of health condition studied
cesarean-section
ICD-10 code
P03.4
ICD-10 code description
Newborn (suspected to be) affected by Cesarean delivery

Primary outcomes

1

Description
attitude in relation to type of delivery
Timepoint
before and one month after the intervention
Method of measurement
Childbirth Attitudes Questionnaire

2

Description
childbirth self-efficacy
Timepoint
before and one month after the intervention
Method of measurement
Childbirth Self-Efficacy Questionnaire

3

Description
decision-making in relation to type of delivery
Timepoint
before and one month after the intervention
Method of measurement
using a researcher-made check list to investigate of decision-making in relation to type of delivery

Secondary outcomes

1

Description
Fear of childbirth
Timepoint
before and one month after the intervention
Method of measurement
Using a harmen childbirth attitude questionnaire

Intervention groups

1

Description
Intervention group: For the intervention group, motivational interviewing group sessions will be conducted in four sessions of 90 minutes, two sessions a week, at the clinic and at agreed time with women in groups of 4 to 9 people.
Category
Prevention

2

Description
Control group: The control group will only receive routine pregnancy training.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hadi Health Center
Full name of responsible person
Maryam Liaghat
Street address
Moalem Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
3819845672
Phone
+98 54 3341 3934
Email
zu.healthdeputy@gmail.com

2

Recruitment center
Name of recruitment center
kosar Health Center
Full name of responsible person
Malihe Bizhanpur
Street address
Sadra Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816832554
Phone
+98 54 3328 9120
Email
zu.healthdeputy@gmail.com

3

Recruitment center
Name of recruitment center
Imam javadi Health Center
Full name of responsible person
Mahbube Gholami
Street address
Razi Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9835444678
Phone
+98 54 3344 1898
Email
zu.healthdeputy@gmail.com

4

Recruitment center
Name of recruitment center
Musabne Jaafar Health Center
Full name of responsible person
هاجر عباسی
Street address
Mirzaye Shirazi Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
6826134675
Phone
+98 54 3322 1854
Email
zu.healthdeputy@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Taheri
Street address
Zahedan University of Medical Sciences, Khhalije fars Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Phone
+98 54 3329 5796
Email
taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Navaee
Position
Master degree, faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Behdasht Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816838192
Phone
+98 54 3344 4510
Email
helennavaee@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Navaee
Position
Master degree, faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Behdasht Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816838192
Phone
+98 54 3344 4510
Email
helennavaee@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Navaee
Position
Master degree, faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Behdasht Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816838192
Phone
+98 54 3344 4510
Email
helennavaee@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information about study implications
When the data will become available and for how long
Starting the access period from 2019
To whom data/document is available
academic researchers
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
by emil: helennavaee@gmail.com
What processes are involved for a request to access data/document
10 days
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