1-Determining the effectiveness of mindfulness-based intervention on breastfeeding self-efficacy and mother-infant attachment in primiparous women
Design
Clinical trials with control group at 3-5 days after giving birth: Randomized
Settings and conduct
The study will be done on 46 primiparous women with a score of their self-efficacy less than 49 who were referred to Ahwaz Medical Center No. 1. The study will be a randomized controlled trial with two intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:First time pregnancy; breast feeding: lactating self-efficacy less than 49
Exclusion criteria: : Use of prohibited drugs on breastfeeding; and having neonate with galactosomia
Intervention groups
Intervention group will receive mindfulness-based education weekly during 8 weeks by researcher:while control group will receive only routine care.(No intervention)
Main outcome variables
Mother's attachment: Lactation self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181031041516N1
Registration date:2019-01-17, 1397/10/27
Registration timing:retrospective
Last update:2019-01-17, 1397/10/27
Update count:0
Registration date
2019-01-17, 1397/10/27
Registrant information
Name
Shahin Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3447 0164
Email address
moradi_sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-21, 1397/08/30
Expected recruitment end date
2018-12-08, 1397/09/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of mindfulness-based intervention on breastfeeding self-efficacy and mother-infant attachment in primiparous women
Public title
The Effect of Mindfulness on the Breastfeeding self-efficacy and Mother's Attachment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
First time pregnancy
Literacy at least third of middle
The age range of the mother is between 18-35 years old
Normal delivery
Just breastfeed
singleton neonate
Agree to take part in the study
Lactation self-efficacy score is less than 49
Exclusion criteria:
Use of prohibited drugs on breastfeeding
Newborn with Galactosomia
Maternal addiction to alcohol
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Qualified mothers were randomly divided into two groups of intervention and control group with the using four-way blocks and a one-to-one assignment ratio.
To avoid bias Twenty-three of the four-digit paired numbers were selected as codes of participants in the intervention group and Twenty-three of the four-digit individuals were selected as the control group code from the random numbers table. To hide the allocation, the number of intervention and control groups were arranged in block envelopes, respectively. Eventually, The envelopes were given to the participants by an accidental crash center.
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 Ahvaz University of Medical Sciences
Street address
Golestan Ave, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-11-09, 1397/08/18
Ethics committee reference number
IR.AJUMS.REC.1397.601
Health conditions studied
1
Description of health condition studied
Breastfeeding self-efficacy and maternal-infant attachment
ICD-10 code
Z39.1
ICD-10 code description
Encounter for care and examination of lactating mother
Primary outcomes
1
Description
Breastfeeding self-efficacy
Timepoint
Measure self-efficacy before intervention and measure one month and two months after the intervention
Method of measurement
Breastfeeding self-efficacy questionnaire
Secondary outcomes
1
Description
Maternal-infant attachment
Timepoint
Before Intervention and After Intervention
Method of measurement
Avant review checklist
Intervention groups
1
Description
Intervention group:for this group 8 sessions of 120 minutes counseling of mindfulness will be held weekly.The content of sessions will be as follow: First and second session :introduction and orientation with group members: explain the relationship between the physiology of breastfeeding and mindfulness: explaining the basics of maternal attachment . Third and fourth sessions: management of attachment skills to meet the needs of the baby and breastfeeding will be taught. Fifth and sixth sessions:encouraged to Exclusive breastfeeding. Seventh and eighth sessions: principles of counseling of mindfulness will be reinforced.
Category
N/A
2
Description
Control group: For this group, control group will receive only routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Around the east of Ahwaz
Full name of responsible person
Nahid Javadifar
Street address
Shahid Rastegari Street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3221 5633
Email
Javadifar-n@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Golestanstreet Ahvaz university of medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
javadifar-n@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Shahin Moradi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan street; Ahvaz university of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
moradi_sh@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid Javadifar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan street; Ahvaz university of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
javadifar-n@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahin Moradi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan street; Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
moradi_sh@ajums.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