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Impact of counseling on motivational interviewing approach on exclusive breastfeeding in nulliparous women

Protocol summary

Study aim
Determining the effect of counseling on motivational interviewing approach on exclusive breastfeeding in nulliparous women in Mashhad health centers in 1397
Design
Clinical trials ,Without blindness , randomized.
Settings and conduct
At first, five centers of health centers in Mashhad, Center No. 1 and No. 3 were selected randomly. Then, based on the population coverage and having the right place for consultation, four urban bases were selected. Random assignment of groups using closed envelopes. To prevent the publication or imitation of interventions, 4 urban bases will be placed in two different groups (2 urban bases in the intervention group and 2 in the control group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to participate in the study, No hearing and speech problems, age 18-35 years, gestational age between 34 weeks and 36 weeks,Be single, no pregnancy, no history of surgery or anatomical impairment of breast,Be nulliparous , no specific drug use, no specific disease. Exclusion criteria: a newborn baby is transferred to the intensive care unit, the baby is infected due to problems leading to impairment of breastfeeding, absenteeism More than one meeting in counseling sessions, failure to complete a daily infant feeding report for 11 days in the follow-up period, The baby's birth weight is below 2500.
Intervention groups
The intervention consists of four group counseling sessions for 75 minutes based on the motivational interview structure. The control group receives the routine care from the health center.
Main outcome variables
Average score for exclusive breastfeeding in the neonatal period

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180731040651N1
Registration date: 2019-07-11, 1398/04/20
Registration timing: retrospective

Last update: 2019-07-11, 1398/04/20
Update count: 0
Registration date
2019-07-11, 1398/04/20
Registrant information
Name
Faeze Aliasghary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7624 2196
Email address
aliasgharif951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of counseling on motivational interviewing approach on exclusive breastfeeding in nulliparous women
Public title
Effect of training on breastfeeding in primipara mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian race Residence in Mashhad Access to phone Minimal fifth degree of elementary education Staff not employed in the hospital No smoking and alcohol There are no audible and verbal problems that prevent communication with the researcher Age between 18 and 35 years old Gestational age between 34 weeks 36 weeks In the last 6 months have not had severe mental problems singleton No high risk pregnancy There is no history of breast surgery or anatomical defects in the breast The absence of known embryonic anomalies in ultrasound The maternal BMI is between 19/8 and 26 Be nulliparous. Desire to cooperate No specific drug intake No specific disease
Exclusion criteria:
The next baby is transferred to the intensive care unit Occurrence of postpartum disaster Occurrence of postpartum medical problems The baby is infected with problems that lead to impairment in breastfeeding A visit has not been done in the first week or the fourth week Missing more than one meeting in counseling sessions Mother suffered from postpartum depression Failure to complete the daily infant feeding report for 11 days during the follow-up period The baby's birth weight is under 2500 The age at birth is below 37 weeks The Apgar score is below 7
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization.By lottery
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
Ethics Committee of Mashhad University of Medical Sciences and Health Services
Street address
Deputy of Research and Technology University, Mashhad University of Medical Sciences, Opposite University Street 18,University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
05138430249
Approval date
2018-07-03, 1397/04/12
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.001

Health conditions studied

1

Description of health condition studied
Exclusive Breastfeeding during neonatal period
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The rate of exclusive breastfeeding in the neonatal period
Timepoint
Determine the amount of exclusive breastfeeding at the end of a 4 week infant
Method of measurement
Daily Feeder Checklist

Secondary outcomes

1

Description
Attitude towards exclusive breastfeeding
Timepoint
Before intervention, four weeks after childbirth
Method of measurement
The score of the questionnaire of Attitude towards exclusive breastfeeding

2

Description
The frequency of exclusive breastfeeding plan
Timepoint
Before intervention, four weeks after childbirth
Method of measurement
The score obtained from the exclusive breastfeeding questionnaire intention

3

Description
Self-efficacy of exclusive breastfeeding
Timepoint
Four weeks after childbirth
Method of measurement
Breastfeeding self-efficacy questionnaire.

Intervention groups

1

Description
Intervention group: Four groups of motivational interviewing counseling sessions will be held in the 35,36,37,38 weeks of pregnancy for 75 minutes per session based on the structure developed by the researcher and approved by a professor of psychology.
Category
Behavior

2

Description
Control group: The routine consultation on exclusive breastfeeding will be provided by midwives at health centers.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center No. 3 of Mashhad
Full name of responsible person
Brattali Arab Nejad
Street address
in front of the payam 6, Khayyam Boulevard, 8 Ershad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185837715
Phone
+98 51 3763 4007
Email
presidentoffice@mums.ac.ir

2

Recruitment center
Name of recruitment center
Health Center Number one
Full name of responsible person
Dr. Naser Amini
Street address
Health center number one in Mashhad city, between Vakil Abad 66 and 68, Vakil Abad Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9179793945
Phone
+98 51 3501 8011
Email
presidentoffice@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Darabi Mahbub
Street address
Presidential Building of Khorasan Razavi University of Medical Sciences and Health Services, Quraishi Building, University of Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
91357-345
Phone
+98 51 3007 3841
Email
presidentoffice@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Faeze Aliasghari
Position
Masters student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery of Mashhad, Doctora Crossroads, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Aliasgharif951@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
sedighe yusefzade
Position
Academic staff of Mashhad University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery of Mashhad, Doctora Crossroads, University Street
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
yousefzadehs@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
sedighe yusefzade
Position
Academic staff of Mashhad University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery of Mashhad, Doctora Crossroads, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
yousefzadehs@mums.ac.ir

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
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data can be shared with the original outcome
When the data will become available and for how long
6 months after registering the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
All lactating women
From where data/document is obtainable
Email faliasghary@gmail.com and the library of the Mashhad Nursing and Midwifery Faculty to the University of Mashhad address.
What processes are involved for a request to access data/document
First, an email is requested and can be submitted to the Nursing Faculty Library of Mashhad in case of non-response within a maximum of one week.
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