Protocol summary

Summary
The present study is a randomized clinical trial on 100 women who give birth to a child in Imam Khomeini hospitals in 2014 and its aim is to determine the effect of kangaroo care on the general health status of mothers after delivery. Inclusion criteria: natural child birth, term pregnancy, 1stpregnancy and a healthy baby and mother's age between 18 to 35 years. Exclusion criteria: Mother's infection, diagnosed mental illness, baby hospitalization. Data collection tools are demographic characteristics questionnaire and Goldenberg general health questionnaire which items are physical health, anxiety, social functioning, and depression. With reference to the postpartum ward, the general heath questionnaire is completed by the women who spend the first day of the delivery. If they score over 23 they are chosen as research samples and are placed in two groups, case and control, randomly. Kangaroo care case group takes place, two times per day and each time half an hour for two months. The educational pamphlet and also KMC CD and its benefits are given to mothers. GHQ will be completed by researcher at the end of the first week, first month, second month through telephone. The control group gets necessary training and education on the benefits of routine care of the newborn baby and mother and baby & mother skin contact and the Questionnaire is completed by the end of the first week, first month, second month. Health scores of the two groups are compared, and the results will be announced

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014052117787N1
Registration date: 2014-11-22, 1393/09/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-22, 1393/09/01
Registrant information
Name
Najme Palizvan
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8621
Email address
palizvan.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-04-28, 1393/02/08
Expected recruitment end date
2014-05-10, 1393/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of kangaroo mother care on maternal general health
Public title
The Effect of Kangaroo Mother Care on Maternal General Health
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: natural child birth, Term pregnancy, first pregnancy, mother's age between 18 to 35 years, healthy baby Exclusion criteria:Mother's infection; diagnosed mental illness; baby hospitalization
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
If score achieved is more than 23, research samples will be selected and they will be numbered from 1 to 100, then randomly samples having even numbers will be placed in case group and those having odd numbers in control group.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Jundishapur University of Medical Sciences, Ahvaz, Iran
Street address
Golestan Street, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Approval date
2014-04-27, 1393/02/07
Ethics committee reference number
rec.1393.20.agums

Health conditions studied

1

Description of health condition studied
General health status after childbirth
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Promotion of Maternal General Health
Timepoint
First day, End of First week, End of First month, End of Second month
Method of measurement
By Goldenberg's General Health Questionnaire

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Intervention group: A researcher teaches attentive samples into group and some of the mothers individual.Kangaroo care brochures and C.D s are given to mothers
Category
Other

2

Description
control group: .Essential training for usual care of newborn baby is given
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahwaz
Full name of responsible person
Najme Paliznan
Street address
Azadegan Street, Imam Khomeini Hospital, Ahvaz, Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Full name of responsible person
Mostafa Feghhi
Street address
Golestan street, Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Najme Palizvan
Position
Student of Master of Science (M.S.) in midwifery
Other areas of specialty/work
Street address
Golestan Street, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1373 8331
Fax
+98 61 1373 8333
Email
palizvan.najme1200@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Najme Palizvan
Position
Student of Master of Science (M.S.) in midwifery
Other areas of specialty/work
Street address
Golestan street, Ahvaz Jundishapur University of Medical sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1373 8331
Fax
+98 61 1373 8333
Email
palizvan.najme1200@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Jundishapur University of Medical Sciences
Full name of responsible person
Najme Palizvan
Position
Student of Master of Science (M.S.) in midwifery
Other areas of specialty/work
Street address
Golestan Street, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1373 8331
Fax
+98 61 1373 8333
Email
palizvan.najme1200@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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