This study evaluate the effect of Kangaroo Contact (KC) on some physiological and neurobehavioral responses of the term newborns and mothers pain profile in Fatemiye hospital in Shahrood-Iran. In a randomized controlled trail, 160 mother-infant dyads will be recruited in KC and routine care (RC) groups. In intervention group, KC will be done three 60 min/day for 2 consecutive days. After cesarean section (C/S), Pain intensity will be determined by verbal numeric analogue scale (0-10 score) in all women. Temperature will be observed in four sets for each neonate. Mean of reflexes score, incidence of jaundice and urine cortizol in newborns will be compared between two groups. Before discharge, the rate of satisfaction in mothers will be gathered by a checklist. Two groups will be followed for exclusive breastfeeding until six months postpartum.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806172324N2
Registration date:2009-09-08, 1388/06/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-09-08, 1388/06/17
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1813
Email address
keshavarz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrood Universoty of medical sciences and health services
Expected recruitment start date
2007-09-28, 1386/07/06
Expected recruitment end date
2008-09-20, 1387/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Kangaroo mother care on neonates and their mothers who delivered by cesarean section
Public title
Effects of Kangaroo mother care in neonates and their mothers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : Iranian women with single and term pregnancy, 18-40 years old, with history of cesarean section delivery (only general anesthesia in current C/S); No pre-existing medical complications or obstetrics complications in current pregnancy, divorce , unwilling neonate’s sex, history of psychiatric illness or illicit drug use; also healthy neonate with no need to resuscitation or hospitalization in NICU. Exclusion criteria: unwilling to continuing of intervention, neonate admission in NICU.
Age
From 21 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrood University of medical sciences and health services
Street address
Haft tir square
City
Shahrood
Postal code
Approval date
2007-07-13, 1386/04/22
Ethics committee reference number
8605
Health conditions studied
1
Description of health condition studied
mothers and neonate in cesarean section unit- kangaroo mother care
ICD-10 code
82.8
ICD-10 code description
Other single delivery by caesarean section
Primary outcomes
1
Description
Neurobehavioral response of Term neonate
Timepoint
daily
Method of measurement
urine cortisol , check list and questionnaire
2
Description
Decrease in pain profile in mothers
Timepoint
daily
Method of measurement
visual analoge pain scale
Secondary outcomes
1
Description
Exclusive Breast Feeding
Timepoint
6 months after delivery
Method of measurement
check list
Intervention groups
1
Description
Kangaroo mother care
Category
Prevention
2
Description
Routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemiyeh hospital
Full name of responsible person
Maryam Keshavarz
Street address
Bistodo Bahman street
City
Shahrood
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrood University of medical sciences and health services
Full name of responsible person
Maryam Keshavarz
Street address
Haft Tir square
City
Shahrood
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrood University of medical sciences and health services
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
Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
MSc in midwifery - academic member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave, P.P. Box: 19395-4798
City
Tehran
Postal code
4798/19395
Phone
+98 21 8247 1406
Fax
+98 21 8879 3805
Email
m_keshir@yahoo.com , keshavarz@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
MSc in midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasami St. Valiasr Ave, P.P. Box: 19395-4798
City
Tehran
Postal code
19964
Phone
+98 21 8247 1406
Fax
+98 21 8879 3805
Email
m_keshir@yahoo.com , keshavarz@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
MSc in midwifery- academic member
Other areas of specialty/work
Street address
Rashid Yasami St. Valiasr Ave, P.P. Box: 19395-4798
City
Tehran
Postal code
Phone
Fax
Email
m_keshir@yahoo.com , keshavarz@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)