Comparing the effect of breast-Milk and leg massage on neonate’s pain intensity during Heel-blood sampling among hospitalized neonates in neonatal intensive care unit
This study is a randomized crossover clinical trial aimed at comparing the effect of breast milk and leg massage on the pain intensity of 30 healthy neonates during a 2-phase heel-blood sampling in Neonatal Care Unit of Fayazbakhsh Hospital, Iran in 2016. This study is designed in such a way that each neonate included in the study will receive both interventions (leg massage and breast milk) with a 12-hour wash-out period between each of these interventions during which the baby does not receive any intervention. The neonates, based on randomly number schedule, are divided into two groups (leg massage and breast milk). In other words, each neonate undergoes two times of heel lance (left and right heel). Babies are placed in the supine position and heel lance is done by the researcher and intensity pain is determined based on the NIPS scale.
The program of breastfeed group: Three ml of the breast milk taken 5 minutes before heel stick is poured in the baby’s mouth slowly in drop by drop for 30 seconds. Then, the heel stick is done by the researcher and proceeded to determine the baby's pain during blood sampling and it goes through the NIPS scale for 2 minutes.
Afterward, not any intervention is performed on neonate for 12 hours. Then, after breast milk program, the process of renewed heel lance on the other neonate heel is accomplished.
The program of leg massage: Five minutes before the heel stick, the investigator slowly massages the outer aspect of the chosen leg for the heel stick from toes to mid thigh for 3 minutes by using a firm but gentle pressure with fingers and thumbs. After massage, the heel stick is done by the researcher.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062928696N1
Registration date:2016-10-12, 1395/07/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-12, 1395/07/21
Registrant information
Name
Afsane Afkhami
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
afkhami@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of breast-Milk and leg massage on neonate’s pain intensity during Heel-blood sampling among hospitalized neonates in neonatal intensive care unit
Public title
The effect of breast milk and leg massage on pain control in preterm neonates hospitalized in neonatal intensive care unit
Purpose
Other
Inclusion/Exclusion criteria
Inclusion: Premature baby with gestational age between 34-37 week, breast feeding, birth weight of 2kg and more, no respiratory distress, no surgery, One and five minutes Apgar score between 7-10, no congenital heart and enteric disease; healthy skin, no sepsis and intelligent neonate.
Exclusion criteria: Unstable infant, those with head and skull deformities, congenital heart disease, cleft palate, cleft lip, and those who had received an analgesic in the 24 hours prior to sampling.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Randomization is done using random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences.
Street address
Central building of Shahid Sadoughi University of Medical Sciences, Bahonar square
City
Yazd
Postal code
8916978477
Approval date
2016-06-08, 1395/03/19
Ethics committee reference number
IR.SSU.REC.1395.43
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Pain intensity
Timepoint
before, at the moment and after intervention
Method of measurement
NIPS scale
Secondary outcomes
empty
Intervention groups
1
Description
The program of breastfeed group: Three ml of the breast milk taken 5 minutes before heel stick is poured in the baby’s mouth slowly in drop by drop for 30 seconds. Then, the heel stick is done by the researcher and proceeded to determine the baby's pain during blood sampling and it goes through the NIPS scale for 2 minutes.
Afterward, not any intervention is performed on neonate for 12 hours. Then, after breast milk program, the process of renewed heel lance on the other neonate heel is accomplished.
Category
Other
2
Description
The program of leg massage: Five minutes before the heel stick, the investigator slowly massages the outer aspect of the chosen leg for the heel stick from toes to mid thigh for 3 minutes by using a firm but gentle pressure with fingers and thumbs. After massage, the heel stick is done by the researcher.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid fayaz bakhsh hospital
Full name of responsible person
Dr.Mohammad Hossein Gholizadeh
Street address
Khalije Fars street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahid Sadoughi University of Medical Sciences.
Full name of responsible person
Tahere Salimi
Street address
Nursing and Midwifing Faculty, Bou ali street, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Tahere Salimi
Position
MSC, The member of faculty
Other areas of specialty/work
Street address
Nursing and Midwifing Faculty, Bou Ali street
City
Yazd
Postal code
8916978477
Phone
+98 35538241751
Fax
+98 82 49705
Email
Salimi_tahere@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Tahere Salimi
Position
MSC, the member of faculty
Other areas of specialty/work
Street address
Nursing and Midwifing Faculty, Bou Ali street, Yazd
City
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Fax
+98 82 49705
Email
Salimi_Tahere@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Social security organization
Full name of responsible person
Afsane Afkhami
Position
MSC student
Other areas of specialty/work
Street address
Number 57 - Mehrdad bulding - Golha Ave - 1st bime street
City
Tehran
Postal code
1391936481
Phone
+98 21 4466 6890
Fax
+98 66270060
Email
afkhami@ssu.ac.ir; 49afkham@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)