Protocol summary

Study aim
To determine the effect of health promotion education based on the Pender model on breastfeeding self-efficacy and mother-infant attachment in primiparous mothers at Shohada Hospital in Behshahr city in 1403.
Design
The research sample will be selected using the available sampling method. The research unit will also be given written and verbal assurance that during the study, if they do not wish to continue participating in the study, they can withdraw from the study. It will also be explained to the mothers that they may be randomly assigned to the test or control group, and that the control group will not be deprived of education, and breastfeeding education will be provided to them according to the hospital's breastfeeding support routine. After obtaining informed consent, random allocation will be made to two control and test groups using a simple method using the website. The sample size in this study was calculated as 50 people using G power software .
Settings and conduct
This experimental study is a pre-test and post-test type with two control and test groups., the researcher introduces himself to the authorities of the Behshahr City SHohada Hospital.
Participants/Inclusion and exclusion criteria
All primiparous mothers
Intervention groups
Training sessions will be held for 6 sessions ( based on needs assessment, individually and in groups. In the group training section, 30-minute training sessions will be provided based on the Pender Health Promotion Model in proportion to the dimensions of health-promoting behaviors, including diet, physical activity, feeling responsible for personal health, attention to spiritual growth, interpersonal relationships, and stress management .
Main outcome variables
Breastfeeding-based health promotion, breastfeeding self-efficacy, mother-infant attachment

General information

Reason for update
Acronym
خودکارآمدی شیردهی
IRCT registration information
IRCT registration number: IRCT20250603066048N1
Registration date: 2025-07-31, 1404/05/09
Registration timing: retrospective

Last update: 2025-07-31, 1404/05/09
Update count: 0
Registration date
2025-07-31, 1404/05/09
Registrant information
Name
razie ezzatpanah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3453 5104
Email address
razie.ezp70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-04, 1404/03/14
Expected recruitment end date
2025-07-05, 1404/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of health promotion based on the Pender model on breastfeeding self-efficacy and mother-infant attachment in primiparous mothers of
Public title
Effect of health promotion based on the Pender model on breastfeeding self-efficacy and mother-infant attachment in primiparous mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
primiparous mothers Singleton babies
Exclusion criteria:
Having an underlying medical condition in the mother multiple mother Drug addiction
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In order to assign randomly, each of the samples was given a numbering code and the numbers will be placed in an envelope. For randomization, a random number table is used, which has 99 rows and columns, and the row and column numbers are arranged in five-digit blocks next to each other and in a separated manner. In order to use the random number table, first start by reading the table numbers, predetermined (in the row or column direction). The point selection is done by closing the eyes and placing a finger or pen tip on the table and unconsciously encountering two types of numbers. Then odd numbers are assigned to group A and even numbers to group B. The researcher places his hand on one of the numbers in the table and moves upwards and records the numbers in one of the groups A and B. depending on whether they are even or odd. Finally, one of the groups is randomly selected as the intervention group and the other as the control group.
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
Islamic Azad University, Aliabad Katul Branch
Street address
University Boulevard
City
Ali Abad katoul
Province
Golestan
Postal code
کدپستی: 49417-93451
Approval date
2025-06-01, 1404/03/11
Ethics committee reference number
IR.IAU.AK.REC.1404.006

Health conditions studied

1

Description of health condition studied
Pender Model Health Promotion
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Breastfeeding self-efficacy
Timepoint
Before and after the intervention in the experimental and control groups
Method of measurement
Breastfeeding self-efficacy questionnaire

Secondary outcomes

1

Description
Mother-infant attachment
Timepoint
Before and after the study in the experimental and control groups
Method of measurement
Mother-infant attachment questionnaire

Intervention groups

1

Description
Intervention group: Then, training sessions will be held individually and in groups for 6 sessions (three times a week) based on needs assessment. In the individual training phase, training will be given according to the mothers' individual needs and their questions will be answered based on previous experiences, education level and social status. After the intervention, the test group will complete the Dennis Breastfeeding Self-Efficacy Questionnaire and the Muller Mother-Infant Attachment Questionnaire again.
Category
Lifestyle

2

Description
Control group In the control group, they will also receive routine interventions and training from the ward and will not be released. In order to ensure faimess, educational materials will be provided to the control group after the end of the study so that they too can benefit from this intervention
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
SHohada Hospital
Full name of responsible person
Razie Ezzatpanah
Street address
Mahdie Ave.
City
Behshar
Province
Mazandaran
Postal code
4851799551
Phone
+98 11 3454 0022
Email
Razie.ezp70@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Aliabad katoul
Full name of responsible person
Azade Naeimi
Street address
Daneshgai Blvd
City
Aliabad katoul
Province
Golestan
Postal code
49417-93451
Phone
+98 11 3422 4500
Fax
+98 11 3422 5673
Email
Razie.ezp70@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Aliabad katoul
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
Islamic Azad University
Full name of responsible person
Razie Ezzatpanah
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mahdie AVE
City
Behshahr
Province
Mazandaran
Postal code
4851799551
Phone
+98 11 3454 0022
Email
Razie.ezp70@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Razie Ezzatpanah
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mahdie Ave
City
Behshar
Province
Mazandaran
Postal code
4851799551
Phone
+98 11 3454 0022
Email
Razie.ezp70@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ezzatpanah Razie
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Jomhori51
City
Behshahr
Province
Mazandaran
Postal code
4851799551
Phone
+98 11 3454 0022
Email
Razie.ezp70@gmail.com

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
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Omitting part of the data, such as information related to the main outcome
When the data will become available and for how long
Access period starts 6 months after results are published.
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Without conditions
From where data/document is obtainable
razie-ezp70@gmail.com
What processes are involved for a request to access data/document
No duration
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