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IRCT20230724058904N2 IRCT 2023-08-08 Ahvaz University of Medical Sciences Investigating the effect of non-nutritive feeding and olfactory stimulation with breast milk on pain and behavioral responses caused by PICC implantation in premature infants. Investigating the effect of non-nutritive feeding and olfactory stimulation with breast milk on pain and behavioral responses caused by PICC implantation in premature infants. 2023-08-23 anticipated 64 Complete https://irct.ir/trial/71662 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sample selection is done in such a way that all eligible samples are listed, then each of them is given a number that is set according to coincidence. There was no particular order in writing these numbers. In the following, the necessary number of samples will be randomly selected from among the numbers. In replacing people in the control and intervention groups, the method of randomly transformed blocks is used. In this way, the samples eligible to enter the study are selected and randomly placed in two intervention and control groups. N/A Condition 1: Pain in premature babies. Condition 2: Premature infants. Intervention 1: Intervention group: After wearing a clean gown, wash your hands and arms completely with antimicrobial cleaning materials for three minutes. Then warm your hands with a warmer to get the right temperature. The researcher must make sure that no painful procedures and other pain relieving interventions have been performed 30 minutes before the PICC insertion and the implementation of interventions to prevent bias in the conclusions. Also, the mother was present at the baby's bedside half an hour before. No nutrition has been done. PICC insertion will be done by one of the trained and experienced and licensed personnel in the department. 2 minutes before PICC insertion, a 2 x 2 cm cotton ball containing 2.5 ml of breast milk is placed 3 cm from the baby's nose. The breast milk used in the intervention group was from their own mother, milked by hand and collected before breakfast to avoid the effect of food consumption on its smell, and then frozen. And it is heated to room temperature before intervention and used. In order to perform non-nutritive sucking, a pacifier suitable for the size of the baby's mouth is used 5 minutes before the insertion of the PICC. It should be noted that premature babies admitted to the special department for babies of Imam Khomeini Hospital are continuously under heart monitoring and pulse oximetry. And with continuous measurement of vital signs and indicators such as breathing rate and breathing depth - breathing sounds and breathing patterns - pulse quality and checking for symptoms of respiratory distress including jumping of nasal fins - retraction and increased breathing rate and also according to the history of the disease And the current condition of the patient can estimate the stability of the clinical and physiological condition. Pain in these babies will be measured in three stages before, during and after the intervention using the PIPP tool. Considering that PIPP evaluates the behavioral and physiological indicators of the baby, therefore, the time required to observe the behavior of the baby is 20 seconds and the behavioral and physiological indicators are considered 30 seconds. Intervention 2: Control group: The method of doing work in the control group is that 2-3 minutes before PICC insertion, during work and 30 seconds after, pain is measured. Parallel to the intervention group, pain score and physiological and behavioral indicators will be measured in the control group using PIPP. 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 Nahid Naseri
Faculty of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan Blvd.
ahvaz Iran (Islamic Republic of) 1579 61357 +98 61 3311 0000 nahid.naseri93@gmail.com Ahvaz University of Medical Sciences scientific Nahid Naseri
Faculty of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan Blvd.
ahvaz Iran (Islamic Republic of) 15794 - 61357 +98 61 3311 0000 nahid.naseri93@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Infants admitted to the NICU and requiring intravenous (IV) therapy through a PICC The need for TPN or antibiotic therapy for at least 7 days and infants with 1 poor or difficult venous access Birth weight above 1500 grams Absence of mother's addiction and use of drugs related to epilepsy and neuropsychiatric disorders Mother's desire and consent to participate the baby in the study The stability of the clinical and physiological condition of the baby No mechanical ventilation The absence of central nervous system damage, convulsions and other cases), congenital anomalies, genetic and metabolic disorders based on the patient's file The baby has an order to fix PICC. 7 months 9 months Both Patients for whom central access has already been fixed Use of peripheral IV catheters and umbilical cord catheters or surgically implanted catheters Significant change in hemodynamic stability and restlessness G89.11 P05.0 Acute pain due to trauma Premature infants Rehabilitation Rehabilitation Intervention group: After wearing a clean gown, wash your hands and arms completely with antimicrobial cleaning materials for three minutes. Then warm your hands with a warmer to get the right temperature. The researcher must make sure that no painful procedures and other pain relieving interventions have been performed 30 minutes before the PICC insertion and the implementation of interventions to prevent bias in the conclusions. Also, the mother was present at the baby's bedside half an hour before. No nutrition has been done. PICC insertion will be done by one of the trained and experienced and licensed personnel in the department. 2 minutes before PICC insertion, a 2 x 2 cm cotton ball containing 2.5 ml of breast milk is placed 3 cm from the baby's nose. The breast milk used in the intervention group was from their own mother, milked by hand and collected before breakfast to avoid the effect of food consumption on its smell, and then frozen. And it is heated to room temperature before intervention and used. In order to perform non-nutritive sucking, a pacifier suitable for the size of the baby's mouth is used 5 minutes before the insertion of the PICC. It should be noted that premature babies admitted to the special department for babies of Imam Khomeini Hospital are continuously under heart monitoring and pulse oximetry. And with continuous measurement of vital signs and indicators such as breathing rate and breathing depth - breathing sounds and breathing patterns - pulse quality and checking for symptoms of respiratory distress including jumping of nasal fins - retraction and increased breathing rate and also according to the history of the disease And the current condition of the patient can estimate the stability of the clinical and physiological condition. Pain in these babies will be measured in three stages before, during and after the intervention using the PIPP tool. Considering that PIPP evaluates the behavioral and physiological indicators of the baby, therefore, the time required to observe the behavior of the baby is 20 seconds and the behavioral and physiological indicators are considered 30 seconds. Control group: The method of doing work in the control group is that 2-3 minutes before PICC insertion, during work and 30 seconds after, pain is measured. Parallel to the intervention group, pain score and physiological and behavioral indicators will be measured in the control group using PIPP. Pain. Timepoint: Before the intervention - during the intervention - and up to 30 seconds after the intervention. Method of measurement: PIPP tool. Behavioral responses. Timepoint: Before the intervention - during the intervention - and up to 30 seconds after the intervention. Method of measurement: PIPP tool. Ahvaz University of Medical Sciences Approved 2023-07-03 Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences Jundishapur University of Medical Sciences, Esfand St., Golestan Boulevard ahvaz Khouzestan Iran (Islamic Republic of)