Protocol summary

Summary
This study was conducted to determine the effects of Kangaroo care on postpartum blues. In this study was conducted in a clinical trial ,148 pregnant women between 37-42 weeks of their gestation referring to obstetric clinic of Hedayat Hospital were selected via purposive sampling method. Inclusion criteria: 18-35 year old women with singleton and requested pregnancies; literate; no history of mental disorders and stress; no traumatic event happened to them during the past 6 months; no history of two or more miscarriages, stillbirth and infertility; no adverse pregnancy outcomes; Exclusion criteria: Birth weight below 2500 gr; mother or baby admitted in hospital; no exclusive breastfeeding; lack of skin to skin contact immediately after birth. The subjects were divided into 2 groups: intervention and control in terms of their delivery date. Intervening variables were matched in the groups. In the experimental group, Kangaroo care was provided daily at several times (or at least 1 time), each lasted 20-30 minutes for 10 days. Stin's postpartum blues questionnaire was also completed in the first, third, fifth, and tenth day after delivery in both groups. Finally, discussion and analysis was performed on 96 subjects. key words: Skin to skin contact, Postpartum Blues, Kangaroo Mother Care

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201101265698N1
Registration date: 2011-10-13, 1390/07/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-10-13, 1390/07/21
Registrant information
Name
Mahbobeh Ahmadi
Name of organization / entity
Shahid Beheshti University of Medical & Health Service
Country
Iran (Islamic Republic of)
Phone
+98 21 7747 5651
Email address
mah.ahmadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
International Branch of Shahid Beheshti Medical University
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2010-12-09, 1389/09/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Kangaroo Mother Care on Postpartum Blues in women referring to hedayat hospital of Tehran in 2011
Public title
The effect of Kangaroo Mother Care on Postpartum Blues in women referring to hedayat hospital of Tehran in 2011
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 18-35 year old women with singleton and requested pregnancies; Gestational age greater than 37 and less than 42 completed weeks, (the date of last menstrual period or first trimester ultrasound; literate; no history of mental disorders and stress; no traumatic event happened to them during the past 6 months; no history of two or more miscarriages, stillbirth and infertility; no adverse pregnancy outcomes; Exclusion criteria: Birth weight below 2500 gr; mother or baby admitted in hospital; no exclusive breastfeeding; lack of skin to skin contact immediately after birth.
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: 96
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
the international Branch of Shahid Beheshti University of Medical & Health Service
Street address
No 19, Shahid Abaspoor St, Next to Hemat Bridge, Valiasr Ave, Tehran, Iran
City
Tehran
Postal code
3693-14155
Approval date
2010-08-22, 1389/05/31
Ethics committee reference number
1768/116

Health conditions studied

1

Description of health condition studied
Postpartum Blues
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified

Primary outcomes

1

Description
Postparum blues
Timepoint
with intervention, On the days of first, third, fifth and tenth postnatal
Method of measurement
Stein's Postpartum blues questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
in this study the intervention was conducted as kangaroo mother care. kangaroo mother care the condition that the newborn in the shortest time befor delivery (c/s or nvd)was kept betwen mother's brests While only a hat, socks and covered his genitals and which was kept warm. with the cover that was on her lung, her lung. This trend was provided daily for 10 days, several times a day depending on the tolerance of the mother and baby (at least once) and each was at least 30-20 minutes.
Category
Behavior

2

Description
In the control group don't intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
hedayat hospital
Full name of responsible person
Fatemeh Abaseian Azar
Street address
Hedayat St. Yakhjal St. Shariati Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
International Branch of Shahid Beheshti Medical Univercity
Full name of responsible person
Fatemeh Abaseian Azar
Street address
The International Branch of Shahid Beheshti Medical Univercity of Medical & Health Service
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
International Branch of Shahid Beheshti Medical Univercity
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
Shahid Beheshti University of Medical & Health Service
Full name of responsible person
Mahbobeh Ahmadi
Position
m.a.obstetric/
Other areas of specialty/work
Street address
Nursing & Midwfery college of Shahid Beheshti University- Valiasr Ave. erly of Neayesh Hih way
City
tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
mah1372@yahoo.commah.ahmadi@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
The International Brench of Shahid Beheshti University 0f Medical & Health Service
Full name of responsible person
Fatemeh Abaseian Azar
Position
M.A. OF Obstetric/ student
Other areas of specialty/work
Street address
No 19, Shahid Abaspoor St, Next to Hemat Bridge, Valiasr Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 26 1221 3168
Fax
Email
ab.mds142@yahoo.comnarges142@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Fatemeh Abaseian Azar
Position
M.A. OF Obstetric
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
ab.mds142@yahoo.comnarges142@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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