The effect of Kangaroo Mother Care postpartum depression in mothers with premature infants
Design
randomized clinical trial with community-based with parallel groups (pragmatic control group).
Settings and conduct
At the NICU (Neonatal intensive care unit) in hospitals affiliated to Zanjan University of Medical Sciences and on mothers with premature infants. Kangaroo Mother Care was performed practically and mother was requested to place her naked neonate on her bare chest for half an hour three times a day. It will continue for ten days.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Singleton pregnancy, preterm infants between 36-36 weeks of gestation, mothers with reading and writing skills.
Exclusion Criteria:
The baby needs nutritional supplements, the mother has a known mental illness.
baby with a serious illness or congenital or genetic abnormalities, the mother has physical illnesses such as hale syndrome, eclampsia or preeclampsia, hysterectomy, severe bleeding, etc., caused by delivery, requiring special care and treatment. .
Intervention groups
In the 45-person intervention group, mothers with preterm infants, in addition to routine care, were trained the Kangaroo Mother Care method, in which a naked infant was placed on the mother's bosom for ten days. In the control group of 45 people, only regular care was provided. Before and 10 days after the end of the intervention, the Edinburgh Depression List were completed by both groups.
Main outcome variables
Postpartum depression in mothers with preterm infants
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171230038142N6
Registration date:2019-02-16, 1397/11/27
Registration timing:registered_while_recruiting
Last update:2019-02-16, 1397/11/27
Update count:0
Registration date
2019-02-16, 1397/11/27
Registrant information
Name
Khosro Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9134
Email address
tavakol@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of postpartum Kangaroo Mother Care on depression in mothers with premature infants
Public title
The effect of postpartum Kangaroo Mother Care on depression in mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Singleton pregnancy
Premature infants between 32-36 weeks of gestation
Mother has reading and writing skills.
Exclusion criteria:
The baby needs nutritional supplements.
The mother has a known mental illness.
The baby has a serious illness or congenital or genetic abnormalities.
Mother suffers from physical illnesses such as Hell's syndrome, eclampsia or pre-eclampsia, hysterectomy, severe bleeding, etc., caused by delivery, requiring special care and attention.
Age
No age limit
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The selection of mothers was by convenience and then simple random method. In this way, 90 questionnaires were prepared, on the top, number one was written on 45 of them and number two on other 45 questionnaires. Then mothers were asked to complete a questionnaire. Number 1 was for control and number 2 was for intervention groups.
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
Deputy of Research of Islamic Azad University of Medical Sciences of Tehran
Street address
Islamic Azad University, Tehran Medical Sciences Branch, Khaghani St., Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
IR.IAU.TMU.REC.1397.269
Health conditions studied
1
Description of health condition studied
Postpartum Depression
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes
Primary outcomes
1
Description
Postpartum Depression
Timepoint
Before the intervention, 24-48 hours after birth and 20 days after the first intervention
Method of measurement
Postpartum Depression Inventory 10th Anniversary of Edinburgh
Secondary outcomes
empty
Intervention groups
1
Description
The group, in addition to the usual care of premature baby, 24 - 48 hours after delivery, performed the method of Kangaroo Mother Care by placing the naked baby on the mother's bare chest for ten days, three times a day , below a linen cover.
Category
Treatment - Other
2
Description
Control group: only received recommendations for the care of preterm infants.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital Zanjan Social Security
Full name of responsible person
Mehran Dukht Nakavand
Street address
Imam Hossein Zanjan Hospital, near Koy Farhang
City
Zanjan
Province
Zanjan
Postal code
٨٦٩١١-٤٥١٩٧
Phone
+98 24 3356 2001
Email
hos.emam.zanjan@tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehran Dukht Nakavand
Street address
Islamic Azad University, Tehran Medical Sciences Branch, Khaghani St., Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
mnakavand@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mehran Dukht Nakavand
Position
Assistant Professor & Research Deputy
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Tehran Medical Sciences Branch, Khaghani St., Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
mnakavand@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehran Dukht Nakavand
Position
Assistant Professor & Research Deputy
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Tehran Medical Sciences Branch, Khaghani St., Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
mnakavand@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehran Dukht Nakavand
Position
Assistant Professor & Research Deputy
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Tehran Medical Sciences Branch, Khaghani St., Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
mnakavand@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The information can be shared with the coordination of Tehran University of Medical Sciences's research vice after being unidentifiable.
When the data will become available and for how long
Starting the access period two years after the publication of the article.
To whom data/document is available
Students, professors and researchers in nursing, psychology and psychiatric groups.
Under which criteria data/document could be used
To compare the information and the results with a similar clinical approach or psychology or other psychological testing.
From where data/document is obtainable
Firstly, by sending an email to mnakavand@hotmail.com, you will be asked to speak clearly, and then, with the coordination of the research and student affiliation of Tehran University of Medical Sciences, the documentation can be obtained.
What processes are involved for a request to access data/document
Send the request to mnakavand@hotmail.com and then coordinate the research and student affiliation of Tehran University of Medical Sciences.