Determining the effect of counseling with a positivist psychology on the self-efficacy of unsuccessful breastfeeding mothers
Design
A randomized controlled clinical trial with parallel groups will be performed on 46 patients.
Settings and conduct
The study population in the study will be selected from all pregnant mothers who failed in previous breastfeeding referring to comprehensive health centers in Zanjan.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Failure of the pregnant mother in previous breastfeeding;
Multipar mothers;
Single pregnancy;
Pregnant mothers with a self-efficacy score between 33 and 76;
Lack of anatomical problem in the breast such as nipple depression and fissure;
Willingness to participate in the study;
Tendency to breastfeed;
Literacy;
Internet access and Android phone.
Criteria for non-admission:
mother suffering from mental disorders;
Incidence of stressful events (accidents, death of a loved one, separation from a spouse, bankruptcy, severe disputes, immigration) in the last 6 months;
Complications of pregnancy or childbirth;
Congenital anomalies in the previous infant;
The previous infant was admitted to the neonatal intensive care unit.
Intervention groups
In the 32nd to 37th weeks of pregnancy, positive psychology interventions will be held in eight sessions of 70-90 minutes, virtually and individually, two days a week, and the control group will receive routine pregnancy care training.
Main outcome variables
Self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160521027994N9
Registration date:2021-09-30, 1400/07/08
Registration timing:registered_while_recruiting
Last update:2021-09-30, 1400/07/08
Update count:0
Registration date
2021-09-30, 1400/07/08
Registrant information
Name
Taraneh Emamgholi khooshehchin
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8318
Email address
khoosheh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-21, 1400/06/30
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling with a positivist approach on self-efficacy of unsuccessful breastfeeding mothers
Public title
The effect of counseling on breastfeeding self-efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Failure of the pregnant mother in previous breastfeeding
Multipar mothers
Single pregnancy
Pregnant mothers with a self-efficacy score between 33 and 76
Tendency to breastfeed the baby
Lack of anatomical problem in the breast such as nipple depression and fissure
Willingness to participate in the study
Literacy
Internet access and Android phone
Exclusion criteria:
Mother suffering from mental disorder
Incidence of stressful events (accidents, death of a loved one, separation from a spouse, bankruptcy, severe disputes, immigration) in the last 6 months
Complications of pregnancy or childbirth
Congenital anomalies in the previous infant
The previous infant was hospitalized in the neonatal intensive care unit
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, at first, the easy sampling method will be used, next individuals with inclusion criteria will be divided into two groups of intervention and control, by using random block division. In this way, in the beginning , by using four blocks, the arrangement of people next to each other in each block will be determined; Thereafter a number will be assigned to each block, and 12 blocks will be determined to provide the required number of samples. Then, the table of random numbers is going to be used, the sequence of using the blocks will be determined. The process of entry to each group in each block will be done by the arrangement of inside the block and the number of selected blocks ;The number of people in each group will be 23.
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 Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2021-07-24, 1400/05/02
Ethics committee reference number
IR.ZUMS.REC.1400.152
Health conditions studied
1
Description of health condition studied
Self-efficacy in breastfeeding
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-efficacy
Timepoint
Before the intervention, the last consultation session and two months after the end of the intervention
Method of measurement
Dennis Breastfeeding Self-Efficacy Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Counseling with a positive psychology approach for the intervention group will be held twice a week for 8 sessions of 70-90 minutes, and at the end of each session, participants will be given homework.
Category
Other
2
Description
Control group: In the control group routine care will be performed. Positive psychological counseling sessions will be held for them if they wish the participants in the control group after the intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive urban health centers
Full name of responsible person
Parvaneh - Rezaie
Street address
zanjan
City
zanjan
Province
Zanjan
Postal code
4513665758
Phone
+98 24 3344 4280
Email
parvaneh.r2020@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Doctor Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi Square, Zanjan
City
zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 4133 8138
Email
shoghli@zums.ac.ir
Grant name
Thesis
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
Parvaneh - Rezaie
Position
Senior Counselling Student In Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School Of Nursing and Midwifery, Carmandan Boulevard, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513665758
Phone
+98 24 3344 4280
Email
parvaneh.r2020@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Taraneh Emamgoli Khooshehchin
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School Of Nursing And Midwifery, Carmandan Boulevard, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 4133 8138
Email
khoosheh@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Parvaneh - Rezaie
Position
Senior Counselling Student In Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School Of Nursing And Midwifery, Carmandan Boulevard, Zanjan
City
zanjan
Province
Zanjan
Postal code
4513665758
Phone
+98 24 3344 4280
Email
parvaneh.r2020@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
The release schedule is not yet known
When the data will become available and for how long
The release schedule is not yet known
To whom data/document is available
The release schedule is not yet known
Under which criteria data/document could be used
The release schedule is not yet known
From where data/document is obtainable
The release schedule is not yet known
What processes are involved for a request to access data/document