Comparison of the effectiveness of intermittent counseling approach with the continuous counseling method in improving breastfeeding self-efficacy and continuity among women infected with covid-19
Comparison of the effectiveness of intermittent counseling approach with the continuous counseling method in improving breastfeeding self-efficacy and continuity among women infected with covid-19
Design
The study will be a quasi-experimental study with two intervention groups. The participant will be selected by the convenience sampling method. The sample size will be 46 people.
Settings and conduct
The study setting will be Ayatollah Mousavi Zanjan. The first intervention group, continues breastfeeding counseling will be received daily and the second intervention group intermittent breastfeeding counseling will be received weekly for up to four weeks by phone and Whatsapp. The self-efficacy of breastfeeding will be measured using the Dennis Short Form Questionnaire before, four weeks, and 4 months after delivery, the continuation of breastfeeding will be determined monthly up to 4 months after delivery. We do not have blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Initiation breastfeeding of the baby immediately after delivery, A positive Covid-19 PCR test and Stability of the mother's health and her baby
Exlusion criteria: Childbirth less than 34 weeks of gestation, contraindications to breastfeeding, and the Need special care in mother and her baby
Intervention groups
The first intervention group: زountinus breastfeeding counseling will be received based on an individual approach, daily for 14 days, and the second intervention group: intermittent Breastfeeding counseling will be received weekly up to four weeks by phone and WhatsApp. The first counseling session in both groups will be held by face-to-face approach. Then continued during the hospitalization period and after discharge, according to the mentioned protocols. We do not have a control group in this study.
Main outcome variables
Breastfeeding self-efficacy and continuity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150731023423N19
Registration date:2021-06-29, 1400/04/08
Registration timing:prospective
Last update:2021-06-29, 1400/04/08
Update count:0
Registration date
2021-06-29, 1400/04/08
Registrant information
Name
Azam Maleki
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3345 4264
Email address
malekia@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-01, 1400/04/10
Expected recruitment end date
2021-11-01, 1400/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of intermittent counseling approach with the continuous counseling method in improving breastfeeding self-efficacy and continuity among women infected with covid-19
Public title
Effectiveness of intermittent counseling approach on women infected with covid-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Initiation feeding of the baby immediately after delivery
A positive Covid-19 PCR test
Stability of general health of the mother and her baby
Exclusion criteria:
Childbirth less than 34 weeks of gestation
Contraindications to breastfeeding
The special care in mother and her baby
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
N/A
Randomization description
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 Zanjan University of Medical Sciences
Street address
Zanjan Azadi Blvd. Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2021-05-26, 1400/03/05
Ethics committee reference number
IR.ZUMS.REC.1400.066
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Breastfeeding Self-efficacy
Timepoint
Before intervention, four weeks and four months after delivery
Method of measurement
Dennis Breastfeeding Self-Efficacy Questionnaire
2
Description
Breastfeeding continuity
Timepoint
Monthly up to 4 months after delivery
Method of measurement
Self- report
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group, breastfeeding counseling will be received daily for two weeks individually using telephone and virtual networks (WhatsApp). The content of counseling sessions is in accordance with the latest version of the breastfeeding guidelines in women with Covid 19 that published by the Ministry of Health of Iran and Includes mother and child rooming conditions - Compliance requirements during breastfeeding - Psychological support - Common complaints related to breastfeeding
Category
Prevention
2
Description
The second Intervention group: breastfeeding counseling will be received weekly for four weeks individually using telephone and virtual networks (WhatsApp). The content of counseling sessions is in accordance with the latest version of the breastfeeding guidelines in women with Covid 19 that published by the Ministry of Health of Iran and Includes mother and child rooming conditions - Compliance requirements during breastfeeding - Psychological support - Common complaints related to breastfeeding
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital in Zanjan
Full name of responsible person
Dr.Azam Maleki
Street address
Gavazang Road, Zanjan University of Medical Sciences, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3242 0651
Email
malekia@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Alireza Shogli
Street address
Gavazang Road, Zanjan University of Medical Sciences, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
Email
maryam.karimi.6098@gmail.com
Grant name
Grant code / Reference number
A-11-344-23
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
Maryam.Karimi
Position
Master Student of Counseling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University of Medical Sciences, Zanjan,Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3341 0992
Email
maryam.karimi.6098@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Azam Maleki
Position
Associate professor in Maternal and Child Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University of Medical Sciences, Zanjan,Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0651
Email
malekia@zums.zc.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Azam Maleki
Position
Associate professor in Maternal and Child Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University of Medical Sciences, Zanjan,Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6140
Email
malkia@zums.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
Possibility of dissatisfaction of participants
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