Investigating The Effect of The Motivational Enhancement Therapy (MET) on The Attachment to The Infant, Breastfeeding Self-Efficacy and Desire for Cesarean Section in Mothers Following Traumatic Childbirth
Determining the effect of The Motivational Enhancement Therapy on attachment to the infant, breastfeeding self-efficacy and Desire for Cesarean Section in Mothers Following Traumatic Childbirth
Design
A clinical trial with an intervention and control group, a blind strain, block randomization with R software, on 78 mothers after traumatic childbirth.
Settings and conduct
The study was conducted on mothers hospitalized in the post-partum department at Afzali pur and Payambar Azam Hospitals in Kerman in two intervention and control groups with a size of 39 people.
The intervention is conducted in four sessions, the first in-person session 72 hours after delivery and the subsequent online sessions, one week, two weeks and three weeks after delivery, and the mother is evaluated 2 weeks after the sessions are completed.
Participants/Inclusion and exclusion criteria
Mothers within 72 hours after natural traumatic birth
The baby is a singleton and full term
No history of mental illness based on prenatal medical records
Not taking antidepressants
No death of a first degree relative within the last 6 months
Having no contraindications for breastfeeding
Absence of abnormalities, stillbirths in this pregnancy
Mothers of infants who were admitted to the neonatal intensive care unit
Diagnosis of postpartum depression by a psychiatrist or psychologist
Intervention groups
Intervention group: they receive 4 motivational Enhancement Therapy counseling sessions after delivery, check 2 weeks later after all the sessions
Control group: receives routine care and check-up 5 weeks after delivery
Main outcome variables
The effect of The Motivational Enhancement Therapy on traumatic childbirth, attachment to the infant, breastfeeding self-efficacy, desire for cesarean section
General information
Reason for update
Acronym
Motivational Enhancement Therapy
IRCT registration information
IRCT registration number:IRCT20230622058555N1
Registration date:2023-07-08, 1402/04/17
Registration timing:prospective
Last update:2023-07-08, 1402/04/17
Update count:0
Registration date
2023-07-08, 1402/04/17
Registrant information
Name
zahra kheirandish
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3216 7080
Email address
zahrakheirandish1400@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2024-03-20, 1403/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The Effect of The Motivational Enhancement Therapy (MET) on The Attachment to The Infant, Breastfeeding Self-Efficacy and Desire for Cesarean Section in Mothers Following Traumatic Childbirth
Public title
Investigating The Effect of The Motivational Enhancement Therapy (MET) on The Attachment to The Infant, Breastfeeding Self-Efficacy and Desire for Cesarean Section in Mothers Following Traumatic
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers Following Traumatic Childbirth
Ability to read and write
Ability to participate in counseling sessions
Having a mobile phone with the ability to connect to one of the Iranian media messages
The baby is a singleton and full term
Mothers within 72 hours after natural traumatic birth
Exclusion criteria:
No history of mental illness based on prenatal medical records
Not taking antidepressants
No death of a first degree relative within the last 6 months
Having no contraindications for breastfeeding
Absence of abnormalities, stillbirths in this pregnancy
Mothers of infants who were admitted to the neonatal intensive care unit
Diagnosis of postpartum depression by a psychiatrist or psychologist
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method with R software will be used to assign the sample to two control and intervention groups. The intervention group with
We show "A" and the control group with "B", using R software, the way to assign people to each of the groups is as follows.
ABBAABABAABBBBAAAABABBBAAAABBABBABBAABABA
BAABBABABABABABABABAABBABABAABAABBBABA
After extracting the data from the questionnaire, they will be analyzed using spss software version 21
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will be done for the stage of sample allocation and data analysis, block randomization method with R software will be used to allocate the sample to two control and intervention groups, and for data analysis, the information of individuals without specifying their group will be available. Statistical consultant is placed for analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Razi Faculty, University of Medical Sciences campus, At the beginning of Haft Bagh Blvd
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-06-06, 1402/03/16
Ethics committee reference number
IR.KMU.REC.1402.067
Health conditions studied
1
Description of health condition studied
Mothers following a traumatic birth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Breastfeeding Self-Efficacy
Timepoint
Measurement of Breastfeeding self-efficacy before the intervention and 2 weeks after the intervention
Measurement of The Attachment to The Infant before the intervention and 2 weeks after the intervention
Method of measurement
(Mother-to-infant Bonding Scale) MIBS
3
Description
Desire for Cesarean Section
Timepoint
Measurement of Desire for Cesarean Section before the intervention and 2 weeks after the intervention
Method of measurement
The score obtained from asking a question related to the mother's willingness to cesarean section
Secondary outcomes
1
Description
Traumatic childbirth
Timepoint
Within 72 hours after delivery
Method of measurement
At least one answer is yes
Intervention groups
1
Description
Intervention group: In the intervention group after traumatic natural childbirth, four 30-minute sessions of The Motivational Enhancement Therapy are held within 72 hours after delivery, one week, two weeks and three weeks after delivery, the mothers are evaluated before the intervention and two weeks after the completion of the sessions.
Category
Treatment - Other
2
Description
Control group: receives routine care and is evaluated within 72 hours after delivery and 5 weeks after delivery.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzali pour Hospitals
Full name of responsible person
Dr. Ahmed Anjam Shua
Street address
Imam Pardiseh Afzalipur Highway, Kerman
City
kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3322 2250
Fax
+98 34 3132 8000
Email
afzali@kmu.ac.ir
2
Recruitment center
Name of recruitment center
Payambar Azam Hospitals
Full name of responsible person
Dr. Farzin Kenya
Street address
Abu Hamid St, Kerman
City
kerman
Province
Kerman
Postal code
7614749549
Phone
+98 34 3226 0045
Fax
+98 34 3226 0041
Email
payambarazam.hos@tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
Razi Faculty, University of Medical Sciences campus, At the beginning of Haft Bagh Blvd
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
+98 34 3132 5219
Email
intdep2@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Firoozeh Mirzaee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Razi Faculty, University of Medical Sciences campus, At the beginning of Haft Bagh Blvd
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
009834313225219
Email
f_mirzaee@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Firoozeh Mirzaee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Razi Faculty, University of Medical Sciences campus, At the beginning of Haft Bagh Blvd
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
+98 34 3132 5219
Email
f_mirzaee@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Firoozeh Mirzaee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
University of Medical Sciences campus, At the beginning of Haft Bagh Blvd
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
f_mirzaee@kmu.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