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The effect of infant care training and sharing the experiences of peer groups on infants' growth status, breastfeeding self-efficacy and quality of life of mothers

Protocol summary

Study aim
Determining the effect of infant care training program and sharing the experiences of peer group based on cyberspace on the growth rate of infant anthropometric indices, breastfeeding self-efficacy and quality of life of mothers
Design
A randomized clinical trial is performed on 114 mothers and the information is completed and collected in two groups of control and test during two stages of pre-test-post-test
Settings and conduct
After obtaining the necessary permits for sampling, the researcher will refer to the health centers in Yazd with these permits and after explaining the work process to the officials and employees of these centers with the aim of attracting their participation and cooperation, will start the sampling process.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the mother's willingness to participate in the study, nulliparous mothers, having a minimum literacy, having an infant under two years old, the child's physical health and no underlying disease, access to mobile phones or other tools to attend Cyberspace, and the ability to use cyberspace. Exclusion criteria: a history of maternal anxiety and depression disorders, use of anti-anxiety and anti-depressant medications
Intervention groups
Intervention group: two-month training program in the form of sending training packages related to breastfeeding, growth and development, vaccination, health and nutrition and other care of children under two years old, along with sharing mothers' experiences. Control group: receiving routine services.
Main outcome variables
Breastfeeding self-efficacy, quality of life, Anthropometric indices

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210913052457N1
Registration date: 2021-10-09, 1400/07/17
Registration timing: prospective

Last update: 2021-10-09, 1400/07/17
Update count: 0
Registration date
2021-10-09, 1400/07/17
Registrant information
Name
forogh okhovat ghahfarokhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3338 2219
Email address
f.okhovat@iaushk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of infant care training and sharing the experiences of peer groups on infants' growth status, breastfeeding self-efficacy and quality of life of mothers
Public title
The effect of infant care training and sharing the experiences of peer groups on infants' growth status, breastfeeding self-efficacy and quality of life of mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study Primiparous mothers having a minimum literacy having a baby under two years old the child's physical health and no underlying disease, access to mobile phones or other tools to be present in cyberspace the ability to use social media
Exclusion criteria:
A history of mothers' anxiety disorders Taking anti-anxiety and anti-depressant medications
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
Using the lottery method, mothers who will enter the study be asked to choose a card. These cards will be in the envelope, with the words control or test on them. Thus, based on the mother's choice, she will be placed in the control or intervention 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
Faculty of Health - Shahid Sadoughi University of Medical Sciences, Yazd (Research Ethics Committee)
Street address
Alam Square, Anonymous Martyrs Boulevard, Medical Sciences Campus, Faculty of Health
City
Yazd
Province
Yazd
Postal code
891517316
Approval date
2021-10-02, 1400/07/10
Ethics committee reference number
IR.SSU.SPH.REC.1400.096

Health conditions studied

1

Description of health condition studied
self-efficacy of breastfeeding mothers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Quality of life score in the quality of life questionnaire 36 questions in two groups of control and intervention
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
36-Question Quality of Life Questionnaire

2

Description
Breastfeeding self-efficacy score in the Dennis Breastfeeding Self-efficacy Questionnaire In two groups of control and intervention
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Dennis Breastfeeding Self-efficacy Questionnaire

Secondary outcomes

1

Description
Anthropometric indices of infants in control and intervention groups
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Meters and scales

Intervention groups

1

Description
Intervention group: Intervention group: All mothers in the experimental group become members of the WhatsApp virtual group, which is managed by researcher with a master's degree in pediatric nursing, PhD in health education. In addition, other members of this group in cyberspace are a midwife and a family doctor in order to answer mothers' specialized questions. Therefore, mothers will have quick access to the nurse, doctor and midwife regarding their questions. In this group, two days a week for two months, an educational program will be conducted by the researcher in the form of sending educational packages related to breastfeeding, growth and development, vaccination, health and nutrition and other care for children under two years old (educational content - Table 1). ). These packages will be sent to mothers based on the latest references in pediatric nursing books approved by the Ministry of Health and approved by the family doctor. Two days after sending the educational materials in the group for mothers, the researcher (babysitter) will teach the necessary additional explanations about the educational content for the mothers for 40 minutes and the mothers will ask their questions, to ensure the promotion of awareness and learning. Research units are evaluated at the end of the first month of mothers by answering questions designed from the educational content taught by the researcher. In addition, mothers in this group are able to share their experiences related to the growth and development of their children over a period of three months. Share each other in cyberspace
Category
N/A

2

Description
Control group: The control group receives routine care in health centers
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd city health center
Full name of responsible person
Seyed Ali Akbar Mousavi Nodoushan
Street address
Ayatollah Kashani Street next to Bahman Ghadim Hospital
City
Yazd
Province
Yazd
Postal code
۸۹۱۳۷۸۳۳۴۳
Phone
+98 35 3624 8021
Fax
+98 35 3628 7198
Email
Dr.mousavi@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Shahid Dr. Bahonar Square, Central Organization of Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Second Floor, Vice Chancellor for Research and Technology
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3726 3733
Fax
+98 35 3726 3732
Email
dvc.research@ssu.ac.ir
Web page address
https://web.ssu.ac.ir/index.aspx?lang=1&sub=21
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Islamic Azad University
Full name of responsible person
Forogh Okhovat Ghahfarokhi
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.,18, Alley10, Khayyam2 Ave. West Mirabad
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817936363
Phone
+98 38 3338 2219
Email
foroghokhovat92@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Forogh Okhovat Ghahfarokhi
Position
Faculty Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.18, Alley10, Khayyam Ave, West Mirabad
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817936363
Phone
+98 38 3338 2219
Email
foroghokhovat92@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Forogh Okhovat Ghahfarokhi
Position
Faculty Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 18, Alley 10, Khayyam2 Ave, West Mirabad
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817936363
Phone
+98 38 3338 2219
Email
foroghokhovat92@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
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