The Effectiveness of Stress Management Counseling on Self-efficacy and The Duration of Exclusive Breastfeeding in Primiparous Women
Design
In this Clinical Trial, 96 Eligible Pregnant Women will be selected Using Convenience Sampling Methode and will be randomly allocated into Two Groups of Intervention and Control using 4- Bolcked.The Outcomes of Study are Breastfeeding Self-efficacy and Duration of Exclusive Breastfeeding. Self-efficacy will be checked by Denise's Breastfeeding Self-efficacy Questionnaire in before Intervention, The First Month after delivery and then 4 Months after Delivery. The Duration of Exclusive Breastfeeding and The Level of Lactation will be done using Telephonic Follow-up after Delivery per monthly up to 4 Months after Delivery.
Settings and conduct
Individually Stress Management Counseling will be done for The Intervention Group. Totally 4 Sessions will be done 2 times per Week at 35 and 36th Week of Pregnancy. Consultation Sessions will be held at The Maternity Hospital Preparation at Ayatullah Mousavi Hospital, Imam Hossein Hospital, Health Center No. 3 Zanjan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primiparous, The Absence of Known Systemic and Psychosomatic Diseases in Recent Pregnancy (major depression), Cohen Perceived Stress Scale score higher than 18.
Exclusion criteria: Preterm Delivery, Complications of Pregnancy (Pre-eclampsia and Diabetes), Neonatal Abnormalities, Neonatal Death, The Breastfeeding Contraindication, Not Participating in Counseling Sessions more than Two Sessions
Intervention groups
IIndividually Stress Management Counseling will be done for The Intervention Group. Totally 4 Sessions will be done 2 times per Week at 35 and 36th Week of Pregnancy. Control Group will be got Rotine Care.
Main outcome variables
Breastfeeding Self-Efficacy; Duration Of Exclusive Breastfeeding; Level of lactation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150731023423N10
Registration date:2018-05-23, 1397/03/02
Registration timing:registered_while_recruiting
Last update:2018-05-23, 1397/03/02
Update count:0
Registration date
2018-05-23, 1397/03/02
Registrant information
Name
Azam Maleki
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3345 4264
Email address
malekia@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology of Zanjan University of Medical Sciences
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-08-01, 1397/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect Of Stress Management Counseling on Breastfeeding Self-Efficacy and Duration Of Exclusive Breastfeeding In Primiparous Women
Public title
The Effect Of Stress Management Counseling On Breastfeeding Self-Efficacy And Duration Of Exclusive Breastfeeding In Primiparous Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to Participate in The Study
Having Reading and Writing Skills
Primiparous Women
Wanted Pregnancy
The Gestational Age is 35-36 Weeks
The Absence of Known Systemic and Psychosomatic Diseases in Recent Pregnancy (major depression)
Higher than 18 Based on Cohen Perceived Stress Scale score
Exclusion criteria:
Preterm Delivery
Birth Weight Less than 2500 gr
Complications of Pregnancy (pre-eclampsia and diabetes)
Discontinue Participate to The Study
Fetus with Known Abnormalities
Neonatal Death
Breastfeeding Contraindication
Unexpected Events During Pregnancy Period or After Childbirth Ex. The Death of Relatives
Not Participating in Counseling Sessions more Than Two Sessions,
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible Women will be Selected Using The Convenience Sampling Method and Allocating of The Intervention and The Control Groups will be Randomized Using 4-Block.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
The Intervention Group will be Considered Counseling Sessions and The Control Group will be Received Routine Care.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
•Ethics committee of Zanjan University of Medical Sciences
Street address
Azadi Boulevard
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2017-10-17, 1396/07/25
Ethics committee reference number
ZUMS.REC.1396.165
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
F43
ICD-10 code description
Neurotic, stress-related and somatoform disorders
Primary outcomes
1
Description
Breastfeeding Self-Efficacy
Timepoint
Before Intervention, One Month after Delivery, Four Months after Delivery
Method of measurement
Dennis Breastfeeding Self-Efficacy Questionnaire
2
Description
Duration Of Exclusive Breastfeeding
Timepoint
One Month after Delivery, Two Months after Delivery, Three Months after Delivery, Four Months after Delivery
Method of measurement
Determination of Breastfeeding (at Three Levels: Exclusive Breastfeeding, Breastfeeding, and other Liquids or Formula, Feeding Bottles and Without Breast Milk) followed by the Phone
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: four sessions of stress management counseling individually and face-to-face, 2 sessions per week, each session 2 hours, at 35 and 36 weeks of pregnancy will receive.
Category
Behavior
2
Description
Control group: will receive routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Ayatollah Mousavi Hospital childbirth preparation class
Full name of responsible person
Azizi Elmira, Master of Science in Midwifery Counseling
Street address
Ayatollah Mousavi Hospital, Gavazang Road,Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
Azizielmira@yahoo.com
2
Recruitment center
Name of recruitment center
Zanjan Imam Hussein hospital childbirth preparation class
Full name of responsible person
Azizi Elmira, Msc in Midwifery Counseling
Street address
Imam Hussein hospital, The Beginning of the farhangh, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8299
Email
Azizielmira@yahoo.com
3
Recruitment center
Name of recruitment center
Comprehensive Health Center (3) Childbirth Preparation Class
Full name of responsible person
Azizi Elmira, Msc in Midwifery Counseling
Street address
Comprehensive Health Center (3), Sadi Crossroad, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8264
Email
Azizielmira@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University Of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
Zanjan University Of Medical Sciences, Azadi Boulevard, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
Azizielmira@yahoo.com
Grant name
پایان نامه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University Of Medical Sciences
Full name of responsible person
Azizi elmira
Position
Msc in Midwifery Counseling
Latest degree
Bachelor
Other areas of specialty/work
Street address
Znjan University Of Medical Sciences, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3345 7707
Fax
Email
azizielmira@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University Of Medical Sciences
Full name of responsible person
Dr. Maleki Azam
Position
Maternal & Child Health PhD
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Znjan University Of Medical Sciences, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24334206519
Fax
Email
Makekia@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University Of Medical Sciences
Full name of responsible person
Dr. Maleki Azam
Position
Mother & Child Health PHD
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Znjan University Of Medical Sciences, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24334206519
Fax
Email
Malekia@zums.ac.ir
Web page address
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