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IRCT2016042513691N6 IRCT 2016-07-25 Tabriz University of Medical Sciences The effects of blood sampling place on pain and Physiological indices of premature infants 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 2016-04-01 anticipated 40 Complete https://irct.ir/trial/13481 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive. N/A Condition 1: pain. Condition 2: Blood-sampling. Intervention 1: 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. Intervention 2: 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.
public
scientific Arshadi Bostanabad Mohammad
South Sharyati Ave-Nursing and Midwifery Faculty
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 arshadi@tbzmed.ac.irarshadi-m@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 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. 4 days 8 days Both M79.8 Y84.9 Other specified soft tissue disorders Medical procedure, unspecified Other Other 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. 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. Pain. Timepoint: from 2 minutes to 6 minutes after blood sampling, Every 2 minutes. Method of measurement: Astrid Lindgren Children’s Hospital Pain Scale. 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. Tabriz University of Medical Sciences Approved 2016-05-09 Tabriz University of Medical Sciences South Sharyati Ave.-Nursing and Midwifery Faculty Tabriz Iran (Islamic Republic of)