]>
IRCT20200115046139N1 IRCT 2020-04-24 Faculty of Health Sciences, University of Health Sciences The Effect of Postpartum Skin to Skin Contact on the Pain of First Intramuscular Injection to Newborn Comparison of the Response To First-Intramuscular (IM) Injection Pain In Newborns With And Without Skin To Skin Contact 2020-05-01 anticipated 60 Complete https://irct.ir/trial/45386 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Randomization description: Block randomization will be used. Newborns and their mothers will be assigned to intervention and control groups through block randomization (block size of three). MedCalc program will be used to determine order of randomization, Blinding description: The mother and baby will not be informed about why skin-to-skin contact occurs. N/A Pain of First Intramuscular Injection to Newborn. Intervention 1: Experimental Group: When the baby is born, she/he shall be taken under the radiant heater at the mother’s room, the umbilical clamp shall be put, and the umbilical care shall be provided. After the mother and her baby wear a bracelet, the nappy shall be fastened, the baby cap shall be placed, the baby shall be covered with a preheated cover, and the STSC of the mother and her baby shall be provided. Before the mother takes the baby on her lap, the pulse oximeter probe shall be put on the right hand, and the cardiac apex beat and saturation shall be recorded through this method. Then, the NIPS (Neonatal Infant Pain Scale) shall be applied for pain assessment. The duration of crying, pain, cardiac apex beat and saturation shall be recorded before the STSC. when the baby is taken on her mother’s lap, the duration of crying, pain, cardiac apex beat and saturation shall be recorded after 5-minute STSC. Vitamin K support shall be given from the left leg, intramuscularly. After the Vitamin K support and additional 5-minute STSC, the duration of crying, pain, cardiac apex beat and saturation shall be recorded. After 10-minute STSC in total, the baby shall be taken under the radiant heater. After 5-minute observation under the radiant heater, the duration of crying, pain, cardiac apex beat and saturation shall be recorded, and the procedure shall be ended. Intervention 2: Control group: When the baby is born, s/he shall be taken under the radiant heater at the mother’s room, the umbilical clamp shall be put, and the umbilical care shall be provided. After the mother and her baby wear a bracelet, the nappy shall be fastened, and the baby shall stay under the radiant heater. The pulse oximeter probe shall be put on the right hand, and the cardiac apex beat and saturation shall be recorded through this method. Then, the NIPS (Neonatal Infant Pain Scale) shall be applied for pain assessment. The duration of crying, pain, cardiac apex beat and saturation shall be recorded before STSC. After 5-minutes, Vitamin K support shall be given intramuscularly from the left leg immediately after recording of pain, cardiac apex beat and saturation. 5-minutes later, the duration of crying, pain, cardiac apex beat and saturation shall be recorded. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Leyla Kaya
_38 Üsküdar; Selimiye, Tıbbiye street.
Istanbul Turkey 34668 +90 216 418 96 16 leylakaya02@gmail.com Faculty of Health Sciences, University of Health Sciences scientific Leyla Kaya
No: 38 Üsküdar; Selimiye, Tıbbiye street.
Istanbul Turkey 34668 +90 216 418 96 16 leylakaya02@gmail.com Faculty of Health Sciences, University of Health Sciences Turkey Literate mother and her newborn infant Mother aged between 18-35 years and her newborn infant Mother giving birth to between 37-41 weeks of gestation and her newborn infant Mother having no chronic disease and her newborn infant Mother delivering her baby in a cephalic position and her newborn infant Mother giving birth through vaginal delivery and her newborn infant Mother having no mental or psychological problem and her newborn infant Newborn having 1st-minute APGAR score (scoring system indicating health of newborn) of 7 or above and mother Newborn weighing 2500-4000 gr and mother 1 day 1 day Both Mother having breech delivery and her newborn infant Mother having kiwi, vacuum and forceps-assisted delivery and her newborn infant Multiparous mother and her newborn infant Newborn having an APGAR score of 7 or above after any intervention and mother Newborn needing to be observed in the intensive care unit and mother Newborn having congenital anomaly and mother Newborn receiving oxygen treatment and mother Mother rejecting skin to skin contact after birth and her newborn infant Behavior N/A Experimental Group: When the baby is born, she/he shall be taken under the radiant heater at the mother’s room, the umbilical clamp shall be put, and the umbilical care shall be provided. After the mother and her baby wear a bracelet, the nappy shall be fastened, the baby cap shall be placed, the baby shall be covered with a preheated cover, and the STSC of the mother and her baby shall be provided. Before the mother takes the baby on her lap, the pulse oximeter probe shall be put on the right hand, and the cardiac apex beat and saturation shall be recorded through this method. Then, the NIPS (Neonatal Infant Pain Scale) shall be applied for pain assessment. The duration of crying, pain, cardiac apex beat and saturation shall be recorded before the STSC. when the baby is taken on her mother’s lap, the duration of crying, pain, cardiac apex beat and saturation shall be recorded after 5-minute STSC. Vitamin K support shall be given from the left leg, intramuscularly. After the Vitamin K support and additional 5-minute STSC, the duration of crying, pain, cardiac apex beat and saturation shall be recorded. After 10-minute STSC in total, the baby shall be taken under the radiant heater. After 5-minute observation under the radiant heater, the duration of crying, pain, cardiac apex beat and saturation shall be recorded, and the procedure shall be ended. Control group: When the baby is born, s/he shall be taken under the radiant heater at the mother’s room, the umbilical clamp shall be put, and the umbilical care shall be provided. After the mother and her baby wear a bracelet, the nappy shall be fastened, and the baby shall stay under the radiant heater. The pulse oximeter probe shall be put on the right hand, and the cardiac apex beat and saturation shall be recorded through this method. Then, the NIPS (Neonatal Infant Pain Scale) shall be applied for pain assessment. The duration of crying, pain, cardiac apex beat and saturation shall be recorded before STSC. After 5-minutes, Vitamin K support shall be given intramuscularly from the left leg immediately after recording of pain, cardiac apex beat and saturation. 5-minutes later, the duration of crying, pain, cardiac apex beat and saturation shall be recorded. Pain. Timepoint: Before the procedure, the 5th minute before the procedure, the 10th minute after the procedure, and the 15th minute after the procedure. Method of measurement: Neonatal Infant Pain Scale (NIPS). Crying time. Timepoint: Before the procedure, the 5th minute before the procedure, the 10th minute after the procedure, and the 15th minute after the procedure. Method of measurement: Crying time will be evaluated by timer. Cardiac apex beat. Timepoint: Before the procedure, the 5th minute before the procedure, the 10th minute after the procedure, and the 15th minute after the procedure. Method of measurement: Cardiac apex beat and saturation shall be recorded through a pulse oximeter probe. Oxygen saturation. Timepoint: Before the procedure, the 5th minute before the procedure, the 10th minute after the procedure, and the 15th minute after the procedure. Method of measurement: Oxygen saturation shall be recorded through a pulse oximeter probe. Faculty of Health Sciences, University of Health Sciences Approved 2019-12-04 Clinical Research Ethics Committee of Zeynep Kamil Women's and Children's Diseases Training and Rese No: 10 Üsküdar; Op. Dr. Burhanettin Üstünel street Istanbul Istanbul Turkey