Protocol summary

Study aim
To determine The effect of counseling with skill training approach on postpartum maternal functioning
Design
Randomized controlled trial with two parallel arms
Settings and conduct
This study will be conducted on women who are referred to Tabriz health centers, so that the researcher will attend in the health centers and will select women with first and second birth, based on their records and invite them to participate in the study through phone contact. In the face to face meeting, the Barkin Maternity Functioning Questionnaire will be completed, and women who receive a score of under 80 will be included in the study and will receive written consent. Participants will be assigned to two groups of counseling and control. Four counseling sessions will be held for intervention group. Two weeks after the last session, post-test questionnaires including maternal functioning, infant care behavior and maternal self-efficacy will be completed by the participants in both counseling and control groups.
Participants/Inclusion and exclusion criteria
Participants with first and second birth and with maternal functioning score below 80 and postpartum depression score above 12
Intervention groups
For the intervention group, four counseling sessions will be provided from the fourth week after delivery at intervals of one week. The duration of each session will be 60 to 90 minutes. The control group will receive routine care.
Main outcome variables
Maternal functioning at 10 weeks after childbirth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120718010324N49
Registration date: 2019-01-18, 1397/10/28
Registration timing: prospective

Last update: 2019-01-18, 1397/10/28
Update count: 0
Registration date
2019-01-18, 1397/10/28
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-06-19, 1398/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling with skill training approach on postpartum maternal functioning: a randomized controlled clinical trial
Public title
The effect of counseling with skill training approach on postpartum maternal functioning: a randomized controlled clinical trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Woman with First and second birth Maternal functioning score below 80 Mother's ability to take care of the baby Healthy term baby The desire to attend in counseling sessions Not having neonatal anomalies (including diagnosed physical and mental abnormalities) Having at least a secondary or higher education The normal postpartum period until time to enter the study Age between 15 to 49 years
Exclusion criteria:
Uncertainty about being able to attend all consultation sessions Change location to another city Having cardiovascular diseases, high blood pressure, liver disease and other chronic diseases, according to the participant's statement Hospitalization of the child Unsolvable lactation problem Obtaining postpartum depression score higher than 12 Neuropsychiatric diseases and recent disasters according to mother expression
Age
From 14 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be conducted using the website www.random.org and through blocking with block sizes of four and six and an allocation ratio of 1: 1 to the two groups of counseling and control.
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 Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
513894797
Approval date
2019-01-08, 1397/10/18
Ethics committee reference number
IR.TBZMED.REC.1397.789

Health conditions studied

1

Description of health condition studied
Postpartum maternal functioning
ICD-10 code
Z39.0
ICD-10 code description
Encounter for care and examination of mother immediately after delivery

Primary outcomes

1

Description
Maternal functioning
Timepoint
Before the intervention and 2 weeks after the end of intervention (four weeks after childbirth)
Method of measurement
Maternal Functioning Barkin Index (MFBI)

Secondary outcomes

1

Description
Infant care behavior
Timepoint
Before the intervention and 2 weeks after the end of the intervention (four weeks after childbirth)
Method of measurement
Infant Care Behavior Questionnaire

2

Description
maternal self-efficacy
Timepoint
Before the intervention and 2 weeks after the end of the intervention (four weeks after childbirth)
Method of measurement
Maternal Self-Efficacy Questionnaire (MSQ)

Intervention groups

1

Description
Intervention group: For intervention group, four 60-90 minutes counseling sessions with a skill-based approach will be provided.
Category
Behavior

2

Description
Control group: The control group will received routine care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers of Tabriz city
Full name of responsible person
Fatemeh Karami
Street address
South Shariati
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6969
Email
fatemeh.karami1995@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6969
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Karami
Position
MSc student of conseling in Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 31 5224 1540
Email
fatemeh.karami1995@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
51745-347
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
mirghafourvandm@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing & midwifery faculty, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
Mirghafourvandm@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.i

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Data of participants are privacy.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of clinical study will be published as article.
When the data will become available and for how long
Immediately after publishing the results.
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article
From where data/document is obtainable
Email: mirghafourvandm@tbzmed.ac.ir
What processes are involved for a request to access data/document
Maximum one week after the communication by email.
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