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IRCT20230529058335N1 IRCT 2023-07-19 Mashhad University of Medical Sciences The effect of the nurse's speech on the pain and stress of neonates The effect of the nurse's compassionate speech on the pain and stress of intravenous catheter insertion in premature neonates 2023-07-23 anticipated 60 Complete https://irct.ir/trial/70465 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Blinding description: Outcome assessors, analysts are blinded. The evaluator, who is made up of professors and experts, only performs the grading by watching the movie without sound, and the data analyzer analyzes only through the given numbers from the scales. it is necessary to mention each neonat's form has a code for the control and intervention group, and only I, who record the procedure, know the classification of the codes. N/A The study is about the pain and stress of premature neonats during intravenous catheter insersion.. Intervention 1: Intervention group: 6 nurses who meet the entry criteria are trained in compassionate talking with neonate.And one day, during a shift, they talk to their neonate for at least 45 minutes alternately while taking care. From the second day onwards, whenever the neonate needs veinpuncture, in addition to the usual pain control measures, the nurse will have a compassionate conversation from 5 minutes before the procedure to the end of the procedure. Examinations are done 1 minute before the intervention and the nurse's speech, 30 seconds after the nurse's speech, 1 and 5 minutes after the procedure is finished. the neonate's stress level with the newborn infant stress scale (NISS) and the neonate 's pain level with the premature infant pain profile (PIPP) will be measured. Intervention 2: Control group: For the control group, whenever veinpuncture is needed, the usual pain control measures such as non-nutritive sucking and nesting will be performed. And the examinations are done 1 minute before the start of the intervention, 30 seconds after the insertion of the catheter, 1 and 5 minutes after the procedure is finished. the neonate's stress level with the newborn infant stress scale (NISS) and the neonate's pain level with the premature infant pain profile (PIPP) will be measured. Yes - There is a plan to make this available What will be shared: At the end of the work and after printing the article, with permission from the Mashhad Nursing and Midwifery Faculty and the relevant professors, the information will be accessible in the central library of the Mashhad Nursing and Midwifery Faculty in the student thesis. When: Access starts 2 months after results are published To whom: Researchers working in academic institutions Conditions: Researchers with related fields can use the data and results by mentioning the reference. Where to obtain: Correspondence with project manager Dr. Naghme Razaghi RazaghiN@mums.ac.ir Postal code: 91778-99191 How to obtain: Apply by email Comments:
public Reyhaneh Omidvar
School of Nursing and Midwifery, Doctora Junction, Eibn-sina st.
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 omidvarR4012@mums.ac.ir Mashhad University of Medical Sciences scientific Naghmeh Razaghi
School of Nursing and Midwifery, Ibn Sina St., Doctora Crossroads, University St.
Mashhad Iran (Islamic Republic of) 9137913199 051338591511 RazaghiN@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Entry requirements for neonates : Neonats weighing more than 1 kg Premature neonats with a gestational age of 28 to 34 weeks Since feeding the neonate at least one hour has passed The neonat should be calm and alert The neonats 's hearing is healthy with the OAE test The parents of the neonat must consent to participate in the research Entry requirements for nurses : Willingness to cooperate in this research At least 3 years of work experience in the neonatal intensive care unit 112 days 136 days Both Conditions for non-entry of neonates : The Apgar score of the fifth minute of the neonat should be less than 6 have a major congenital anomaly The neonat need CPAP or connected to a tracheal tube have a history of taking analgesic and sedative medicine in the past 24 hours The neonat's mother should be addict Have a history of surgery Conditions for non-entry of nurses : Violence and tightness of the vocal cords G89.1 Acute pain, not elsewhere classified Behavior Other Intervention group: 6 nurses who meet the entry criteria are trained in compassionate talking with neonate.And one day, during a shift, they talk to their neonate for at least 45 minutes alternately while taking care. From the second day onwards, whenever the neonate needs veinpuncture, in addition to the usual pain control measures, the nurse will have a compassionate conversation from 5 minutes before the procedure to the end of the procedure. Examinations are done 1 minute before the intervention and the nurse's speech, 30 seconds after the nurse's speech, 1 and 5 minutes after the procedure is finished. the neonate's stress level with the newborn infant stress scale (NISS) and the neonate 's pain level with the premature infant pain profile (PIPP) will be measured. Control group: For the control group, whenever veinpuncture is needed, the usual pain control measures such as non-nutritive sucking and nesting will be performed. And the examinations are done 1 minute before the start of the intervention, 30 seconds after the insertion of the catheter, 1 and 5 minutes after the procedure is finished. the neonate's stress level with the newborn infant stress scale (NISS) and the neonate's pain level with the premature infant pain profile (PIPP) will be measured. The amount of pain in neonates of the intervention and control groups will be evaluated. Timepoint: 1 minute before the start of the intervention, the first 30 seconds of the start of the intervention, 1 and 5 minutes after the end of the intervention. Method of measurement: Registering ،the amount of pain in neonates using the (PIPP) premature infant pain profile. The amount of stress in neonates of the intervention and control groups will be evaluated. Timepoint: 1 minute before the start of the intervention, the first 30 seconds of the start of the intervention, 1 and 5 minutes after the end of the intervention. Method of measurement: Registering the amount of stress in neonates using the (NISS) newborn infant stress scale. Success rate in venous catheter placement. Timepoint: After each intervention. Method of measurement: The number of unsuccessful attempts to insert a venous catheter. Mashhad University of Medical Sciences Approved 2023-06-24 Ethics Committee of Mashhad University of Medical Sciences University Street, Central Building of Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)