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IRCT20151107024919N7 IRCT 2019-06-27 Kerman University of Medical Sciences Application of ice bag on vital signs and reducing femoral region pain in patients with MI undergoing percutaneous coronary intervention Effect of ice bag on vital signs and femoral region pain in patients with MI undergoing percutaneous​ coronary intervention 2019-05-22 anticipated 60 Complete https://irct.ir/trial/37507 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Block randomization method. Block randomization works by randomizing participants within blocks such that an equal number are assigned to each treatment.The block size is determined by the researcher and should be a multiple of the number of groups (i.e., with two treatment groups, block size of either 4, 6, or 8) The method used in this study is as follows: BABA"ABBA "AAB"BABA"BBAA" "BAAB "AAB "ABAB"BABA "AABB"BBAA"AABB "ABBA "BAAB"AABB". N/A Acute Myocardial Infarction. Intervention 1: Intervention group: Ice bag (in the size of 15 x 10 cm and weight 250 grams, model BEYBY BASIC model NT_304 from the company Berlyan Toba) will use for 20 minutes in the femur area. Intervention 2: Control group: They will receive routine PCI care before, during and after removing cathter that would be include: immobilization and applying sand bag of affected site. 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 The researcher doesn't have any interest to share because of ethical issues. ( there​ is No further information)
public Batool tirgari
No. 6 Haftbagh Bolv., Razi Faculty of Nursing & Midwifery, Kerman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3226 3719 b_tirgari@kmu.ac.ir Kerman University of Medical Sciences scientific Dr. Batool Tirgari
No. 6 Haftbagh Bolv., Razi Faculty of Nursing & Midwifery, Kerman
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5219 b_tirgari@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Patients with Myocardial infarction undergoing percutaneous coronary intervention Age over 18 Having Iranian nationality Alert Stability of Hemodynamic situation 18 years no limit Both Using sedative and analgesic drugs Emergency status and dangerous arrhythmias Sensention to cold Having Raynaud's disease Mental and physical problems such as visual and auditory disorder Addiction to narcotic and alcohol I21.9 Acute myocardial infarction Other Treatment - Other Intervention group: Ice bag (in the size of 15 x 10 cm and weight 250 grams, model BEYBY BASIC model NT_304 from the company Berlyan Toba) will use for 20 minutes in the femur area Control group: They will receive routine PCI care before, during and after removing cathter that would be include: immobilization and applying sand bag of affected site. Pain. Timepoint: Before, during and after the exiting arterial catheterization. Method of measurement: Numerical Rating Scale for pain. Vital signs. Timepoint: Before, during and after the arterial catheterization. Method of measurement: Monitor that is connecte​d to the patient and thermometer. Kerman University of Medical Sciences Approved 2018-12-10 Ethics Committee of Kerman University of Medical Sciences No, 1, end of Shafa AVE., Shafa Educational Hospital Kerman Kerman Iran (Islamic Republic of)