Protocol summary

Summary
Objectives: To determine the effect of problem solving skills training on self-efficacy and exclusive breastfeeding in primipara women. Design: Study a trial in the field with the control group. How to do: A total of 80 first pregnant women aged 18-35 years old, who were covered with Kashmar health centers during the 36-32 weeks of gestation, were randomly assigned into two groups (test and control). Setting and conduct: Six sessions of problem solving skills training were held that the first session of familiarization and completion of lactation self-efficacy, social problem solving, demographic and later education sessions on breast feeding, common problems, problem and problem solving methods, problem solving and application stages Problem solving was done in breastfeeding. The control group did not receive any intervention. Entry requirements for research: first and second stage pregnancy; having at least elementary education; lack of prediction of lactation; lack of effective lactation; satisfaction to participate in the study; not subject to social psychosocial stress. Main outcomes: low birth weight and preterm delivery; infant being affected by conditions that cause lacrimation disorders such as cleft palate and ...; fattening eaters or mothers; preventing mother from lactation-preventing diseases; using the Effective drugs on breastfeeding; Breastfeeding from the mother during the study; Stressful events during the study; Breast feeding disorders; Breastfeeding; One and more absences; Exit tendency. Interventions: Problem solving skills training was held in 6 sessions in the test group. The main outcome variables are lactation self-efficacy

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017070334872N1
Registration date: 2017-08-01, 1396/05/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-01, 1396/05/10
Registrant information
Name
Atefeh Abbaszadeh
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
a.abbaszadeh@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Gonabad University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of problem solving training on self- efficacy and Exclusive breastfeeding in nulliparous women
Public title
Problem Solving Problems in Breastfeeding
Purpose
Other
Inclusion/Exclusion criteria
Major entry into the study: first and secondarily pregnancy; having at least elementary education; lack of prediction of lactation premature delivery; Not having known known problems affecting breastfeeding for mother and fetus; having satisfaction to participate in a study; being exposed to psychological social stress ((serious illness or spouse, one's relatives' death, immigration, acute economic conditions, marital divorce and Accident)); Main departure conditions: Low birth weight and preterm labor; having a baby in conditions that cause lacrimation disorders such as cleft palate, lacrimal gastric ulcer and etc; fetal death or mother during the intervention; mother's being infected with known diseases The physical and mental impairment of lactation; the use of certain medications that are effective in breastfeeding (bromocriptine, primidone, doxorubicin, marbroate and other drugs that are contraindicated in breastfeeding); admission of breastfeeding in hospital or separation from mother during study; accidents Harsh and stressful (serious illness or spouse, one's close relatives, immigration, acute economic conditions, big differences in women Overshoot and accident) during the study; Breast problems in the breach of breastfeeding, absenteeism and more mother; desire to leave the study.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
N/A
Randomization description
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
"Ethnical Committee of Gonabad University of Medical Sciences"
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
Approval date
2016-07-24, 1395/05/03
Ethics committee reference number
ir.gmu.rec.1395.49

Health conditions studied

1

Description of health condition studied
breastfeeding
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
breastfeeding self- efficacy
Timepoint
Before the intervention immediately after the intervention and 3 months later
Method of measurement
breastfeeding self-efficacy questionnaire

Secondary outcomes

1

Description
Exclusive breastfeeding
Timepoint
Before, immediately after intervention, one and three months later, delivery
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention in the test group of problem solving skills by lecture method in six sessions of the first session. Familiarization and completion of demographic questionnaires, lactation, lactation self-efficacy and social problem solving, and five sessions of education about breast feeding, common problems, problem and problem-solving method, Problem solving and problem solving problem in lactation and lactation questionnaires, lactation self-efficacy and problem solving were immediately followed by education, and three months later, delivery was completed in two groups.
Category
Lifestyle

2

Description
In this study, the control group does not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center of Javdallahme Society
Full name of responsible person
Atefeh Abbaszadeh
Street address
center of Jawad Al-Aimeh, Street Qa'im
City
Kashmar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Gonabad University of Medical Sciences
Full name of responsible person
Doctor Ali Mohammadpour
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Gonabad Medical Sciences
Full name of responsible person
Atefeh Abbazaadeh
Position
Masters of Community Health
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 51 5722 3028
Fax
Email
atefehabaszadeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Shahla Khosrowan
Position
phd
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
Phone
+98 51 5722 3028
Fax
Email
khosravan@gmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Atefeh Abbaszadeh
Position
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
Phone
+98 557223028
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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