The comparison of pain and physiological indices in two ways of blood sampling from vein hand and vein head in premature infants with gestational age 32-28 weeks
This study is a cross-over clinical trial which will conducted with the aim of comparison the pain and physiological changes in two methods of blood sampling from the vein of head and the vein of hand in healthy preterm infants with 28-30 weeks and 30-32 weeks gestational age. Forty samples in two groups would be studied. In the first group, initial blood sampling will be done through the vein of hand and the further blood sampling in the next day will be done through the vein of head. In the second group of infants, blood sampling will be done in reverse. The pain score will be measured. To assess the physiological parameters including heart rate and oxygen saturation, the monitor would be used. Recording time of interventions will be 2 minutes before to 6 minutes after blood sampling.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042513691N6
Registration date:2016-07-25, 1395/05/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-25, 1395/05/04
Registrant information
Name
Mohammad Arshadi Bostanabad
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
arshadi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences-faculty of Nursing and Midwifery
Expected recruitment start date
2016-04-01, 1395/01/13
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of pain and physiological indices in two ways of blood sampling from vein hand and vein head in premature infants with gestational age 32-28 weeks
Public title
The effects of blood sampling place on pain and Physiological indices of premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: gestational age of 28-30 weeks and 30-32 weeks and appropriate weight for gestational age; need for venous blood sampling in 4 to 8 days after birth; absence of congenital malformations and skin lesions on infants’ hands or heads; the absence of blood disorders in mother's medical history; no history of smoking, alcohol and drug consumption by mothers during pregnancy; not using of sedative from 12 hours before sampling; absence of Signs of Asphyxia; Stability of cardio-respiratory status; The intervals between two sampling times more than 24 hours; not receiving invasive interventions in the last six hours before blood sampling.
Exclusion criteria: Parents’ willing to study; multiple try for sampling; report of cerebral hemorrhage or brain abnormalities in cranial ultrasound; inappropriate quality of video to interpretation.
Age
From 4 days old to 8 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
South Sharyati Ave.-Nursing and Midwifery Faculty
City
Tabriz
Postal code
5138947977
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.TBZMED.REC.1395.136
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
M79.8
ICD-10 code description
Other specified soft tissue disorders
2
Description of health condition studied
Blood-sampling
ICD-10 code
Y84.9
ICD-10 code description
Medical procedure, unspecified
Primary outcomes
1
Description
pain
Timepoint
from 2 minutes to 6 minutes after blood sampling, Every 2 minutes
Method of measurement
Astrid Lindgren Children’s Hospital Pain Scale
Secondary outcomes
1
Description
Heart rate , Blood oxygen saturation
Timepoint
from 2 minutes to 6 minutes after blood sampling, Every 2 minutes
Method of measurement
monitor device - Massimo 1600
Intervention groups
1
Description
Eligible infants who need for venous sampling in fourth to eighth days of their birth will be entered to study with convenience sampling method and recruited into two groups randomly. In the first group, first blood sampling through the vein of hand (Cephalic and Basilic veins and dorsal venous plexus back of the hand), the next day blood sampling through the vein of head (Superficial temporal vein in the side of the head and supratrochlear vein in the frontal part of the skull) will be use. For blood sampling from the vein of head, head circumference at the upper part of the eyebrows will be closed with a soft rubber band (Coban) with 1.5 cm of diameter, and for taking blood from the vein of the back of the hand, restriction will be performed via colleague’s hand. Blood sampling will be carried out in direction of blood flow using Bio.Flon IV (No#24) with angle of 15 to 20 degrees in head vein and 25 to 45 degrees in hand vein. Trying to sampling will not be more than once. Pain score will be measured using pain scale. To investigate the physiological indices, a monitor device will be attached to the baby's foot, and heart rate and percentage of arterial oxygen saturation, will be monitored throughout the study. In this study, to record the behavioral and physiological responses to pain two recording devices will be used. One of recording devices will be fixed to monitor to record the pyisiological responses and the next recording device will be focused the baby’s face and limbs to record its behavioral responses.
Category
Other
2
Description
In Newborns of second group, blood sampling will be reversely; in which the first blood sampling will be done through the veins of head(Superficial temporal vein in the side of the head and supratrochlear vein in the frontal part of the skull), and the further blood sampling will be done through hand veins (Cephalic and Basilic veins and dorsal venous plexus back of the hand), in next day. For blood sampling from the vein of head, head circumference at the upper part of the eyebrows will be closed with a soft rubber band (Coban) with 1.5 cm of diameter, and for taking blood from the vein of the back of the hand, restriction will be performed via colleague’s hand. Blood sampling will be carried out in direction of blood flow using Bio.Flon IV (No#24) with angle of 15 to 20 degrees in head vein and 25 to 45 degrees in hand vein. Trying to sampling will not be more than once. Pain score will be measured using pain scale. To investigate the physiological indices, a monitor device will be attached to the baby's foot, and heart rate and percentage of arterial oxygen saturation, will be monitored throughout the study. In this study, to record the behavioral and physiological responses to pain two recording devices will be used. One of recording devices will be fixed to monitor to record the pyisiological responses and the next recording device will be focused the baby’s face and limbs to record its behavioral responses.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Zahra Pourashori
Street address
َSouth Artesh Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Rashidi
Street address
Daneshgah Ave. Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arshadi Bostanabad Mohammad
Position
Assistant Professor
Other areas of specialty/work
Street address
South Sharyati Ave-Nursing and Midwifery Faculty
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
arshadi@tbzmed.ac.irarshadi-m@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)