Protocol summary

Summary
Objective: To evaluate the effect of a kangaroo mother care on pain of invasive procedures in neonatal intensive care unit premature infants Hospital of Hamedan Fatemieh.Design: Quasi-experimental study. Manner: premature infants hospitalized in the neonatal intensive care unit hospital in Hamedan Fatemieh are eligible to enter the study sample will form.Inclusion criteria: infants without symptoms suggestive of severe disease or congenital abnormality that prevents him out incubator, do not,Age at birth of 32-37 weeks , according to records,no under ventilator and intubation , the export of doctor-specialist let newborn infant's hemodynamic stability for participating in the study, pulse oximetry during infant attachment studies.Exclusion criteria: existence or occurrence of any kind of medical or obstetric problem for maternal, infant death during the study, a factor which is not let the baby out of the incubator.Interventions:Kangaroo mother care method involves placing the baby in the mother's arms for 15 minutes before and after action. Primary outcome variables: the outcome of the pain that will be studied with the following methods: (a)Changes in infant pain behavior(facial pain, breathing pattern, legs, hands, level of consciousness) using NIPS pain scale for scoring. (b) Physiological changes (heart rate and arterial oxygen saturation) using pulse oximetry and a number of other physiological signs (pallor, facial flushing, sweating, palm sweating) With observing there is no in 3 stages before, during and after the offensive action will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013021212455N1
Registration date: 2013-02-25, 1391/12/07
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-02-25, 1391/12/07
Registrant information
Name
Maryam Pakseresht
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0439
Email address
m.pakseresht@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic-Chancellor of Research and Technology,Hamadan University of Medical Sciences
Expected recruitment start date
2013-03-05, 1391/12/15
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of kangaroo mother care on premature newborns’ pain due to invasive procedures
Public title
Effect of kangaroo mother care on premature newborns’ pain in neonatal intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Premature infants hospitalized in the neonatal intensive care unit of Hamedan Fatemieh Hospital the following characteristics of the sample will be: A) Infants without symptoms suggestive of severe disease or congenital abnormality that prevents him out incubator.(B) Infants born 32-37 weeks of age, so the age is recorded in the file. (C) The infant ventilator and intube no. (c) Permit the physician to participate in a study of newborn infants based on hemodynamic stability. (d) Connecting newborn pulse oximetry during the study.Babies who have any of the following conditions will be excluded: (a ) Existence or occurrence of any kind of medical or obstetric problems for the mother. (b) The baby died. (c) During the study, a factor which is not allowing the baby out of the incubator.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
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
Local Human Subject Review board
Street address
Hamadan University of Medical Sciences,Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
16/35/9/4000/پ/د

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain

Primary outcomes

1

Description
Pain
Timepoint
Before, during and after invasive procedures
Method of measurement
Scale of pain and pulse oximetry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: kangaroo mother method of placing infants on the mother's chest for 15 minutes before and 15 minutes after invasive procedures
Category
Prevention

2

Description
Control: The control is not a specific intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Fatemeh Cheraghi
Street address
Hamadan, Kermanshah Ave, Pasdaran
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vic-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Tavilani
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Grant name
از محل یک درصد بودجه پایان نامه های دانشگاه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-Chancellor of Research and Technology, Hamadan University of Medical Sciences
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
Hamadan University of Medical Sciences, Faculty of Nursing and Midwifery,Department of Pediatrics
Full name of responsible person
Dr. Fatemeh Cheraghi
Position
PhD, Assistant
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Faculty of Nursing and Midwifery, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0439
Fax
Email
f_cheraghi@umsha.ac.ir, f_cheraghi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Pediatrics
Full name of responsible person
Dr. Fatemeh Cheraghi
Position
Nursing PhD
Other areas of specialty/work
Street address
University of Medical Sciences, Faculty of Nursing and Midwifery, Department of Pediatrics
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0439
Fax
Email
f_cheraghi@umsha.ac.ir, f_cheraghi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Maryam Pakseresht
Position
Master Nursing Student, Pediatric Orientation
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0439
Fax
Email
m.pakseresht@umsha.ac.ir, paksereshtmaryam@yahoo.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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