Effect of facilitated tucking with the nurse and a simulated hand on physiological pain index during vein puncture on premature infants in neonatal intensive care unit.
The goal of the study is to determine the effect of position of fetal in the hand of the nurse or the cloned glove on the physiological indicator during setting the IV for preterm babies with the gestational age of 28- 37 weeks in NICU. The babies are chosen according to the inclusion criteria and are randomly put in one of the three groups of intervention with the nurse’s hand, Intervention with the cloned hand or the control group. There are 33 samples in each group. In the population questionnaire for each baby these factors are determined: gestational age, gender, Birth weight and body temperature. Thirty minutes after putting the baby in the rest position the responsible nurse checks the heart rate, number of breathes and oxygen saturation. These factors are checked again after inserting cannula and five minutes after fixing the intra venous line. To be more exact, monitor’s Trend option can be used. For the intervention group with hands, researcher nurse should wash her hands and put the baby in the fetal position with warm hands by putting one hand on the baby’s head and without any pressure with another hand pushing the legs inside of abdomen. In the group with the cloned hand this position is given to the baby with ergonomic gloves of Zaky. In the control group as the routine no pacifying action is done for the baby.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060128205N1
Registration date:2016-06-27, 1395/04/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-27, 1395/04/07
Registrant information
Name
Zohre Karjoo
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 3724 0171
Email address
n.salmani@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid sadoghi University of Medical Sciences
Expected recruitment start date
2016-06-03, 1395/03/14
Expected recruitment end date
2016-10-05, 1395/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of facilitated tucking with the nurse and a simulated hand on physiological pain index during vein puncture on premature infants in neonatal intensive care unit.
Public title
The effect of fetal positions on pain management in preterm infants Neonatal Intensive Care Unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: premature baby with gestational age between 28 till 37 weeks; no opioid and pain killing drugs and withdrawal syndrome; no Hypothermia; Hypoglycemia and hyperglycemia; no mechanical ventilation; no surgery; five minutes Apgar score more than seven.
Exclusion criteria: All cases are inconsistent with the inclusion criteria
Age
From 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
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
Shahid Sadoughi University of Medical Sciences and Health Services
Street address
central office of university, Bahonar square
City
Yazd
Postal code
8916978477
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.SSU..REC.1394.22
Health conditions studied
1
Description of health condition studied
Comparison effect of facilitated tucking with the nurse and a simulated hand on physiological pain index during vein puncture on premature infants in neonatal intensive care unit.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pian
Timepoint
Before intervention, moment of intervention, five minute after intervention
Method of measurement
Physiologic indicator
Secondary outcomes
1
Description
Average heart rate
Timepoint
Before intervention, moment of intervention, 5 minute after intervention
Method of measurement
Physiologic indicator
2
Description
The average arterial oxygen saturation
Timepoint
Before intervention, moment of intervention, five minute after intervention
Method of measurement
Physiologic indicator
3
Description
The average number of breathing
Timepoint
Before intervention, moment of intervention, five minute after intervention
Method of measurement
Physiologic indicator
Intervention groups
1
Description
For the intervention group with hands, researcher nurse should wash her hands and put the baby in the fetal position with warm hands by putting one hand on the baby’s head and without any pressure with another hand pushing the legs inside of abdomen
Category
Other
2
Description
Zaky gloves used for fetal positions
Category
Other
3
Description
According to the routine will not do nothing to control the pain
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin Hospitsl
Full name of responsible person
Scientific Officer
Street address
Amin Hospital
City
Isfahan
2
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Scientific Officer
Street address
Shahid Beheshti Street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University
Full name of responsible person
Naiire Salmani
Street address
Building number 2, Bahonar square, Shahid Sadoughi University, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University
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 Sadoughi University
Full name of responsible person
NaiireSalmani
Position
Nursing phD
Other areas of specialty/work
Street address
Nursing and Midwifing Faculty, Bou Ali street, Yazd
City
Yazd
Postal code
Phone
+98 35 3824 1751
Fax
Email
n.salmani@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University
Full name of responsible person
Naiire Salmani
Position
Nursing phD
Other areas of specialty/work
Street address
Nursing and Midwifing Faculty, Bou Ali street, Yazd
City
Yazd
Postal code
Phone
+98 35 3824 1752
Fax
Email
n.salmani@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University
Full name of responsible person
Naiire Salmani
Position
Nursing PHD
Other areas of specialty/work
Street address
Yazd
City
Yazd
Postal code
Phone
+98 35 3824 1752
Fax
Email
n.salmani@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)