Determining the effect of family-centered counseling on breastfeeding continuity in women with media technology distractions
Design
Phase III of a randomized controlled trial, with the parallel group, will be conducted on 120 lactating women. We do not have blinding. Eligible women will be selected in the convenience method during regular postpartum care visits, and then will be allocated into two groups using the random block with the size of 4 blocks. The random blocks will be selected using the randomizer software.
Settings and conduct
Lactating women who refer to Zanjan Comprehensive Health Center within the first 42 days after delivery will be randomly assigned into two groups. We do not have blinding. The intervention will be family-oriented counselling in three face-to-face meetings with the participation of at least one family member.
Participants/Inclusion and exclusion criteria
Inclusion criteria Lactating mothers who are two weeks to 42 days postpartum, living with a partner, exclusive breastfeeding or combination feeding, having at least one case of media-induced distraction based on the mother distraction questionnaire.
Exclusion criteria are bottle feeding and Prohibition of breastfeeding
Intervention groups
The intervention group will receive family-centred counselling in three face-to-face sessions with the participation of at least one family member, preferably her spouse. The duration of the sessions is between 45 to 60 minutes and the intervals of one week. Content of sessions includes breastfeeding training based on national guidelines, lifestyle changes, and strategies to reduce distractions during baby care and breastfeeding.
The control group will receive routine care including breastfeeding education based on national guidelines.
Main outcome variables
Continuity of breastfeeding, Technology distraction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150731023423N21
Registration date:2022-08-09, 1401/05/18
Registration timing:prospective
Last update:2022-08-09, 1401/05/18
Update count:0
Registration date
2022-08-09, 1401/05/18
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
2022-08-24, 1401/06/02
Expected recruitment end date
2023-01-30, 1401/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-oriented counseling on breastfeeding continuity in women with distractions caused by media technologies
Public title
The effect of family-oriented counseling on breastfeeding continuity in women with distractions caused by media technologies
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least one case of media-induced distraction based on the mother distraction questionnaire
Breastfeeding mothers who are two weeks to 42 days postpartum.
Living with a spouse
Exclusive breastfeeding or combination feeding
Exclusion criteria:
Bottle feeding
Contraindications to breastfeeding
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
One hundred and twenty eligible women were selected during routine postpartum care visits using the convenience sampling method and then they will be assigned to two groups using a random blocking method with block sizes of four. In this way, six blocks will be assigned to group A (intervention) and group B (control). Then, the number of blocks will be selected using Random Number Table.
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
Ethics committee of Zanajn University of Medical Sciences
Street address
Zanjan University of Medical Sciences Headquarters, the beginning of the Islamic Republic Blvd, Azadi Square, Zanjan. Iran
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۵۶۱۳۱۹۱
Approval date
2022-06-21, 1401/03/31
Ethics committee reference number
IR.ZUMS.REC.1401.136
Health conditions studied
1
Description of health condition studied
Breastfeeding continuation
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Distraction media technologies
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Breastfeeding continuation
Timepoint
Before intervention, Every month up to 4 months after the intervention
Method of measurement
Nutrition Classification System of the World Health Organization to assess the continuity of breastfeeding
2
Description
Media technology distraction
Timepoint
Before intervention, Every month up to 4 months after the intervention
Method of measurement
Maternal Distraction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will be received family-oriented counselling in three face-to-face sessions with the participation of at least one family member, preferably their spouse. The duration of the meetings is between 45 and 60 minutes and the holding intervals are considered to be one week. The content of the sessions includes breastfeeding education based on national guidelines, lifestyle changes and strategies to reduce distractions during baby care and breastfeeding. Including making a list of distractions during breastfeeding, practising mind management strategies to reduce distractions while breastfeeding or taking care of the child, practising not using mobile phones and other media technologies, and a financial agreement as a fine. For a more accurate assessment, daily notebooks will be provided to mothers to record breastfeeding patterns and counselling assignments.
Category
Lifestyle
2
Description
The control group will be received routine care including breastfeeding education based on national guidelines.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
The comprehensive health centers of Zanjan.
Full name of responsible person
Elaheh Arezi Tekantapeh
Street address
Zanjan Health Centers
City
Zanjan
Province
Zanjan
Postal code
5991769164
Phone
+98 44 4552 6622
Email
arezi.eli@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Samad Nadri
Street address
Zanjan University of Medical Sciences, Islamic Republic Street, Azadi Boulevard, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3524 2075
Email
Research@zums.ac.ir
Grant name
Grant code / Reference number
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
Elahe Arezi Takantappe
Position
Master student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 44 4552 6622
Email
arezi.eli@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Maleki Azam
Position
PhD in Maternal and Child Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+9824334206519
Email
Malekia@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Maleki Azam
Position
PhD in Maternal and Child Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+9824334206519
Email
Malekia@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