The aim of this study is to determine the effect of massage versus no massage on pain responses of infants during blood sampling. Design: This is a single-blind randomized controlled clinical trial. This study was conducted on 136 infants within 3 days of birth; affected with hyperbilirubinemia (icter); without congenital anomalies and chromosomal diseases; hospitalized in Mostafa Khomeini hospital affiliated to Shahed University. Infants were randomly studied once as experiment and once as control by using random number tables (68 infants in groups). Researcher assessed the pain responses caused by blood sampling in infants. Physiological (Blood pressure; Respiratory rate; Pulse rate; Oxygen saturation) and behavioral responses of pain (Scale NIPS) were assessed. We assessed pulse rate ؛ blood pressure ؛ respiratory rate؛and oxygen saturation level as physiological responses and we assessed facial expressions (which were measured by neonatal facial coding system) as behavioral responses. In the intervention group massage was used from 1 minute before blood sampling. At any time (experience or control) recording was done two minutes before sampling, after blood sampling and 5 minutes after sampling. Researchers who measure the outcomes of the study subjects are not aware of what the intervention has received by each participant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412127529N7
Registration date:2015-01-11, 1393/10/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-11, 1393/10/21
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University Vice chancellor for research
Expected recruitment start date
2014-10-07, 1393/07/15
Expected recruitment end date
2015-02-04, 1393/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of massage versus no massage on pain responses of blood sampling in infant: a randomized clinical trial
Public title
Effect of massage on pain responses of blood sampling in infant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: gestational age infant between 37-42 weeks; birth weight between 2500 - 4000 gr ; Apgar score above 7 at 5 minutes; within 3 days of birth; ; affected with hyperbilirubinemia ( icter );without congenital anomalies and chromosomal diseases ; neurological diseases; cardiologic or respiratory impairments, infection diseases, and metabolic diseases; any other painful intervention such as circumcision and injection.
Exclusion criteria: Now the bad baby such as undergoing of mechanical ventilation or need to sedative;, the first needling for blood sampling was not successful; receiving sedatives or analgesics for 24 hours before the procedure; addicted mothers; drugs and antidepressants during pregnancy ; With experience endotracheal intubation and CPR; unwillingness the parents for complete the study;
Age
From 3 days old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Infants were randomly studied once as experiment and once as control by using random number tables .
Researchers who measure the outcomes of the study subjects are not aware of what the intervention has received by each participant.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran, Iran
City
Tehran
Postal code
Approval date
2014-11-22, 1393/09/01
Ethics committee reference number
41/215588
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
two minutes prior to sampling, after inserting needle and five minutes after removing the need
Method of measurement
Neonatal Infant Pain Scale( NIPS)
2
Description
Blood pressure
Timepoint
two minutes prior to sampling, after inserting needle and five minuet after removing the need
Method of measurement
phygmomanometer
3
Description
Respiratory rate
Timepoint
two minutes prior to sampling, after inserting needle and five minuet after removing the need
Method of measurement
Checklist
4
Description
Pulse rate
Timepoint
two minutes prior to sampling, after inserting needle and five minuet after removing the need
Method of measurement
Checklist
5
Description
Oxygen saturation
Timepoint
two minutes prior to sampling, after inserting needle and five minuet after removing the need
Method of measurement
pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, massage is done 1 minutes before vein puncture in antecubital local
Category
Other
2
Description
In Control group: no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mostafa Khomini Hospital in Tehran
Full name of responsible person
Dr. Shiva Rafati
Street address
Mostafa Khomini Hospital; Italia street; Tehran; Iran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University Vice chancellor for research
Full name of responsible person
Dr. Zahra Kiasalari
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran Tehran Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University Vice chancellor for research
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
Shahed University
Full name of responsible person
Dr. Shiva Rafati
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran, Iran
City
Tehran
Postal code
Phone
00
Fax
Email
nrejeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran, Iran
City
Tehran
Postal code
Phone
+98 212151210
Fax
Email
nrejeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way , Tehran ,Iran
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)