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IRCT20180116038385N1 IRCT 2018-03-17 Mashhad University of Medical Sciences Effect of Massage on Neonates' Pain Studying the Effect of Massage Therapy on the Pain Caused by Umbilical Venous Catheter in Premature Infants. 2018-03-21 anticipated 50 Complete https://irct.ir/trial/29011 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Blinding description: The Researcher's assistant who controls the symptoms of Infants during a painful procedure, does not know to which group does the Infant belongs. A person who scores the Pain does not know to which group does the Infant belongs. 3 The subject is not a disease.. Intervention 1: After the Infants are stabilized, they are placed on a reanimator under the same conditions (Light, Temperature, Noise), then Massage with the Field Technique is performed for 15 minutes. The Massage time is 15 minutes and includes 3 five minute phases. After completion of Massage, the vital signs and the pain will be measured using PIPP. Then, the Catheter, which is the same for all Infants will be applied under sterile conditions by a Resident who has completed six months of residency. During the insertion of the Venous Catheter, and immediately after it, and 2 and 5 minutes later, the Pain and Vital Signs will be measured using PIPP. Intervention 2: Control group: All of the treatment steps were identical for the infants in the control group except that they were not given massage. Yes - There is a plan to make this available What will be shared: Only part of the information can be shared such as information on the main outcome or the like When: Start the access period 6 months after printing the results To whom: Data will only be available to researchers working in academic and academic institutions Conditions: Allow data from researchers to be obtained Where to obtain: Mashhad University of Medical Sciences, School of Nursing and Midwifery Research Council How to obtain: Send an application to the Vice-Chancellor of the Nursing and Midwifery Faculty and review it at the Research Council and then agree / disapprove the applicant's request Comments:
public Hamid Reza Behnam Vashani
Faculty of Nursing and Midwifery, Avicenna St., Avicenna Street, Mashhad, Iran.
Mashhad Iran (Islamic Republic of) 9188764355 +98 51 3614 6729 behnamhr@mums.ac.ir Mashhad University of Medical Sciences scientific Hamid Reza Behnam Vashani
Faculty of Nursing and Midwifery, Avicenna St., Avicenna Street, Mashhad, Iran.
Mashhad Iran (Islamic Republic of) 0188764355 +98 51 3614 6729 behnamhr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Premature Infants needing a Catheter Umbilical Vein at NICU. The ages of the Infants between 30-37 weeks. Infants weighing over 1000 grams The PIPP score less than 7 before insertion of the Venous Catheter. 1 day 28 days Both Infants of Addicted Mothers Apgar at minute 1 less than 5, and Apgar at minute 5 minutes less than 7 Symptoms of hypoxic-ischemic encephalopathy (HIE). Use of a sedative for the infant in the past 48 hours Other Prevention After the Infants are stabilized, they are placed on a reanimator under the same conditions (Light, Temperature, Noise), then Massage with the Field Technique is performed for 15 minutes. The Massage time is 15 minutes and includes 3 five minute phases. After completion of Massage, the vital signs and the pain will be measured using PIPP. Then, the Catheter, which is the same for all Infants will be applied under sterile conditions by a Resident who has completed six months of residency. During the insertion of the Venous Catheter, and immediately after it, and 2 and 5 minutes later, the Pain and Vital Signs will be measured using PIPP. Control group: All of the treatment steps were identical for the infants in the control group except that they were not given massage. Reducing pain in preterm infants. Timepoint: Before massage, before and after insertion of the venous catheter, at least 2, 5 minutes after insertion of the catheter. Method of measurement: Premature Infant Pain Profile. Mashhad University of Medical Sciences Approved 2017-09-23 Ethics Committee of Mashhad University of Medical Sciences Mashhad School of Nursing and Midwifery Mashhad Razavi Khorasan Iran (Islamic Republic of)