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Comparison of the Effectiveness of Education by Telephone follow-up and Social messaging follow-up on Mothers' self-efficacy and Social support during Lactation and continued Exclusive Breastfeeding

Protocol summary

Study aim
The Effect of two-way Telephone follow-up and Social Messaging on Mothers' continued Breastfeeding, self-efficacy, and Social Support during Lactation
Design
The present Study is a randomized Clinical trial with a Control Group and Two intervention Groups that will be performed on 261 Patients|(87 people in each group). We do not have blindness. Eligible women will be selected by the available method and will be assigned to two intervention groups and one Control Group using a random block of 6.
Settings and conduct
Samples will be examined in Two Groups of Telephone and Virtual intervention and a Control Group in Asali Hospital in Khorramabad. In the Telephone Group, The Researcher will be contacted by the Group Members and on average each Member will be given 20 minutes to provide Educational Material about breastfeeding The Virtual Intervention Group will consist of Mothers who join a Post-delivery Group in one of the Social messengers (Telegram, WhatsApp, etc.) and receive Educational MaterialsVirtually. The Control Group will include Mothers who receive Routine Training by the Nursing Officer and Other Nurses.
Participants/Inclusion and exclusion criteria
Primiparous Mother by natural Delivery Method, with Smart phone with Social messaging capability Mothers with literacy Education Absence of a Medical or Midwifery Problem before, during, and after Childbirth The baby's fetal Age is 38 to 42 Weeks and Birth weight is Between 2500 and 4500 gr Absence of Contraindications for Mother and Baby Lack of a History of Depression and well-known Anxiety Disorders and Depression Medications Exclusion Criteria: Primiparous mother by Cesarean section Prohibition of breastfeeding, Having a mental illness
Intervention groups
1-Intervention Group by Telephone 2-Virtual Intervention Group 3-Control Group
Main outcome variables
Breastfeeding self-efficacy, Social support of breastfeeding mothers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191213045720N1
Registration date: 2020-11-15, 1399/08/25
Registration timing: prospective

Last update: 2020-11-15, 1399/08/25
Update count: 0
Registration date
2020-11-15, 1399/08/25
Registrant information
Name
Mitra Fathi chegeny
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0138
Email address
mitrafathi6969@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-18, 1399/08/28
Expected recruitment end date
2021-01-18, 1399/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Education by Telephone follow-up and Social messaging follow-up on Mothers' self-efficacy and Social support during Lactation and continued Exclusive Breastfeeding
Public title
The effect of Education on Self-efficacy and Social Support and Breastfeeding continuity in Lactating Mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous mothers by natural delivery method, with smart phone with social messaging capability Mothers have minimum Literacy Absence of a Medical or Midwifery Problem before, during, and after Childbirth • The baby's Fetal Age is 38 to 42 Weeks and Birth Weight is between 2500 and 4500 gr Absence of Contraindications for Mother and Baby • Lack of a History of Depression and well-known Anxiety Disorders and Depression Medications •Being in the Range of Depression, Anxiety and Mild to Moderate Stress based on the DASS-21 Scale
Exclusion criteria:
Primiparous mother by cesarean section Existence of medical or obstetric problems of the mother before, during and after delivery There are contraindications to breastfeeding for mother and baby Having a history of known depression and anxiety disorders and taking antidepressants
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 261
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization The present study will be a randomized controlled trial.Samples will be examined in two intervention groups and one control group.In this study, the samples will be included in the study according to the inclusion criteria of the non-probability method.The samples will then be assigned to study groups by block random allocation method.In block randomization method, 6 blocks are used.We have three groups A, B and C. In these blocks we arrange different possible states with A, B and C.For example, the first patient will be assigned to group A, the second patient to group A, the third patient to group B, the fourth patient to group B, the fifth patient to group C, the sixth patient to group C.When the first block is finished, we go to the second block.In the second block, the first patient is assigned to group A, the second patient to group B, the third patient to group A, the fourth patient to group B, and the sixth and fifth patients to group C.According to the arrangement, we proceed so that all patients are divided into three groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of University of Medical Sciences of Lorestan
Street address
6814993165, Lorestan University of Medical Sciences, km 4 of Khorramabad Borujerd Highway, Khorramabad, Lorestan Province,Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Approval date
2019-07-20, 1398/04/29
Ethics committee reference number
IR.LUMS.REC.1398.128

Health conditions studied

1

Description of health condition studied
Exclusive Breastfeeding
ICD-10 code
P92.5
ICD-10 code description
Neonatal difficulty in feeding at breast

Primary outcomes

1

Description
Mothers' awareness of Breastfeeding
Timepoint
Before Intervention, 4 Months after Delivery
Method of measurement
Demographic Questionnaire, Denis Short Self-efficacy Questionnaire, which can Measure Mothers' knowledge through a Self-efficacy Questionnaire where it is based.

Secondary outcomes

1

Description
Breastfeeding Self-efficacy
Timepoint
Once before the Intervention and then 10 Days, 1 Month and 4 Months after Delivery
Method of measurement
Dennis Short Self-efficacy Questionnaire

2

Description
Social Support
Timepoint
Once before the Intervention and then 10 Days, 1 Month and 4 Months after Delivery
Method of measurement
Perceived Social Support Questionnaire

3

Description
Breastfeeding Continuity
Timepoint
Birth time, 4 Months after Delivery
Method of measurement
Lactation Checklist

Intervention groups

1

Description
Intervention group 1: Telephone One of the intervention groups is the telephone group, which will include mothers who received educational materials in the form of files, video booklets and educational videos, and on the first, third, fifth and seventh days after discharge by phone with Questions and answers will be discussed. The researcher will contact the members of the group and each member will be given an average of 20 minutes to present educational materials.
Category
Behavior

2

Description
Intervention group 2: Virtual The virtual group will include mothers who, after giving birth, are members of a group created in one of the social messengers (Telegram, Whats App, etc.) and educational materials in the form of files, video booklets and educational videos in the first days. , Third, fifth and seventh will be sent to their personal page after discharge and will be shared and discussed in the created group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Maternity Hospital Asali
Full name of responsible person
Roza Soltani
Street address
681785454, Asali Maternity, Koye felestin, Khorramabad, Lorestan Province, Iran
City
Khorramabad
Province
Lorestan
Postal code
681785454
Phone
+98 66 3340 6099
Fax
Email
asali.hospital@lums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Ebrahim Flahi
Street address
6814993165, Lorestan University of Medical Sciences, km 4 of Khorramabad Borujerd Highway, Khorramabad, Lorestan Province,Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3340 9974
Email
falahi.e@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fatemeh Valizadeh
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
6814993165, Lorestan University of Medical Sciences, km 4 of Khorramabad Borujerd Highway, Khorramabad, Lorestan Province,Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0155
Email
Valizadeh.f@lums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fatemeh Valizadeh
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
6814993165, Lorestan University of Medical Sciences, km 4 of Khorramabad Borujerd Highway, Khorramabad, Lorestan Province,Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0155
Email
Valizadeh.f@lums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fatemeh Vlizadeh
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
6814993165, Lorestan University of Medical Sciences, km 4 of Khorramabad Borujerd Highway, Khorramabad, Lorestan Province,Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0155
Email
Valizadeh@lums.ac.ir

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
Due to the confidentiality and dissatisfaction of the participants
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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