Comparing effect of neonate's massage, kangaroo mother care and routine cares on neonates' physiological symptoms of pain due to invasive procedures in neonates
This study aim to compare effect of neonate's massage, kangaroo mother care (KMC) and routine cares on hospitalized neonates' physiological symptoms of pain due to invasive procedures. This clinical trial study will conduct on 126 hospitalized term neonates in pediatric ward and NICU of Besat Hospital, Hamadan, Iran, during 2015. Inclusion criteria include lack of symptoms of severe disease or congenital abnormality that prevents neonate to exit from incubator; neonates who will born 32-37 weeks of age based on the age is recorded in the medical record and lack of intubation or connecting to ventilator in neonate. Exclusion criteria include existence or occurrence of any kind of medical or obstetric problems for the mother; neonate die during the study and any situation which do not allow to exit neonate from incubator. Subjects will divide to two intervention groups and one control group according to table of random numbers. In the first intervention group, KMC will perform for 30 minutes and in the second intervention group leg massage will do by mother for 15 minutes. In control group, while neonate is connecting to pulse oximetry in supine position will put in incubator without any touch and change in position. In both intervention groups, the physiological signs of pain in 15 minutes before invasive painful procedures (as minutes zero), during the invasive painful procedures (as minutes 15) and 15 minutes after the invasive painful procedures (as minutes 30) and in control group, in three same time as zero (15 minutes after supine position of neonate in the incubator), 15 (during a painful procedure) and 30 (15 minutes after painful procedures) will observe and record by physiological sign scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052914251N3
Registration date:2015-06-13, 1394/03/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-13, 1394/03/23
Registrant information
Name
MORTEZA NASIRI
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 2622 5292
Email address
nasiri.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic-Chancellor of Research and Technology of Hamadan University of Medical Sciences
Expected recruitment start date
2015-04-01, 1394/01/12
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of neonate's massage, kangaroo mother care and routine cares on neonates' physiological symptoms of pain due to invasive procedures in neonates
Public title
Effect of neonate's massage and kangaroo mother care on neonates' pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: lack of symptoms of severe disease or congenital abnormality that prevents neonates to exit from incubator; lack of any CNS abnormalities; lack of any obstetric or medical problems in mother; neonates who will born in 32-37 weeks of age based on the age is recorded in the medical record; lack of intubation or connecting to ventilator in neonates; approve of hemodynamic stability and allow to neonates participate in the study and exit from incubator by physician.
Exclusion criteria: existence or occurrence of any kind of medical or obstetric problems for the mother; neonate die during the study; any situation which do not allow to exit neonates from incubator.
Age
From 1 day old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
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
Hamadan University of Medical Sciences Ethics Committee
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave, Hamedan.
City
Hamadan
Postal code
Approval date
2015-03-02, 1393/12/11
Ethics committee reference number
16/35/9/6379/P
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
Pain scale and pulse oximetry
Secondary outcomes
1
Description
Heart rate
Timepoint
Before, during and after invasive procedures
Method of measurement
Pulse oximetry
2
Description
Oxygen saturation
Timepoint
Before, during and after invasive procedures
Method of measurement
Pulse oximetry
Intervention groups
1
Description
First intervention group: neonates will place on the mother's chest based on kangaroo mother method for 15 minutes before and 15 minutes after invasive procedures
Category
Prevention
2
Description
Second intervention group: neonates’ leg will massage by mother in 15 minutes before and 15 minutes after invasive procedures
Category
Prevention
3
Description
Control group: while neonate is connecting to pulse oximetry in supine position will put in incubator without any touch and change in position.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital, Hamadan
Full name of responsible person
Maryam Valimalayeri
Street address
Besat Hospital, Mazghineh avenue, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vic-Chancellor of Research and Technology of Hamadan University of Medical Sciences
Full name of responsible person
Dr. Saied Bashirian
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh avenue
City
Hamadan
Grant name
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 of 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
Department of Pediatrics, Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences
Full name of responsible person
Maryam Valimalayeri
Position
MSc student of nursing education
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences, Shaheed Fahmideh avenue
City
Hamadan
Postal code
Phone
+98 81 3833 0641
Fax
Email
valimalayeri@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Pediatrics, Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences
Full name of responsible person
Maryam Valimalayeri
Position
MSc student of nursing education
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh avenue
City
Hamadan
Postal code
Phone
+98 81 3833 0641
Fax
Email
valimalayeri@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Pediatrics, Faculty of Nursing and Midwifery, Hamadan University of Medical Sciences
Full name of responsible person
Maryam Valimalayeri
Position
MSc student of nursing education
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
valimalayeri@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)