Protocol summary

Study aim
Determine the effect of cognitive-behavioral counseling on the onset and continuation of breastfeeding in twin
Design
Clinical trial has two groups of control and intervention, with parallel, one-blind, randomized groups
Settings and conduct
Twin pregnant mothers registered with health centers and randomly divided into two groups, in which the participant does not know which group is located.
Participants/Inclusion and exclusion criteria
Twin pregnancy and literacy at reading and writing
Intervention groups
The intervention group will provide 8 cognitive-behavioral counseling sessions for lactation and the control group will receive routine care only
Main outcome variables
livelihood promotion in mothers with double-breasted milk; lactation after delivery;lactation continuation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180909040976N1
Registration date: 2019-05-05, 1398/02/15
Registration timing: retrospective

Last update: 2019-05-05, 1398/02/15
Update count: 0
Registration date
2019-05-05, 1398/02/15
Registrant information
Name
Samaneh Orak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4362 6716
Email address
samanehorak66@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-30, 1397/04/09
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
2018-06-30, 1397/04/09
Actual recruitment end date
2018-11-21, 1397/08/30
Trial completion date
2018-12-01, 1397/09/10
Scientific title
The effect of cognitive-behavioral therapy on the start and continuation of breastfeeding in twin
Public title
The effect of cognitive-behavioral therapy on the start and continuation of breastfeeding in twin
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Twin pregnancy Read and write Desire to participate in writing a written consent Gestational age 26-28 weeks Approval of gestational age based on first trimester ultrasonography or precise LMP
Exclusion criteria:
Single pregnancy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomized block with four blocks (ABAB)
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 Ahvaz University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz town
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IRAJUMS.REC.1397.287

Health conditions studied

1

Description of health condition studied
start and continuos breastfeeding
ICD-10 code
P92.5
ICD-10 code description
Neonatal difficulty in feeding at breast

Primary outcomes

1

Description
Start and continuation of breastfeeding
Timepoint
29.30.31.32.33.34 Week and 14-15 days and 4 month
Method of measurement
checklist and questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Eight cognitive-behavioral counseling sessions
Category
Behavior

2

Description
Control group: Routine care
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ize Comprehensive Health Services Center
Full name of responsible person
Samaneh Orak
Street address
Comprehensive Health Services Center, Modarres Blvd
City
Ize
Province
Khouzestan
Postal code
6391967994
Phone
+98 61 4362 9324
Email
hn-ize@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2394
Email
Hekmat1346@gmail.cim
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Samaneh Orak
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jundishapur University of Medical Sciences, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 7543
Email
Samanehorak66@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Samaneh Orak
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 7543
Email
samanehorak66@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Samaneh Orak
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 7543
Email
samanehorak66@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
I will share the main outcomes of the study to promote twin of breastfeeding
When the data will become available and for how long
9 months after printing results
To whom data/document is available
researchers
Under which criteria data/document could be used
For use in articles
From where data/document is obtainable
Responsible person
What processes are involved for a request to access data/document
After requesting a maximum of 10 days
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