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IRCT20180701040297N1 IRCT 2019-01-24 Research and Technology Deputy of Guilan University of Medical Sciences Assessing the effect of local cold application over femoral sheath insertion site on low back pain and vascular complications of patients undergoing coronary angiography Assessing the effect of local cold application over femoral sheath insertion site on low back pain and vascular complications of patients undergoing coronary angiography referred to Dr.Heshmat Educational and remedial center in Rasht in 2018-2019 2019-01-20 anticipated 110 Complete https://irct.ir/trial/36539 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Four random blocks were randomly allocated in two groups of intervention (cold pack) and control group, which is routine of the hospital (sand bag). At the beginning of the study, 41 random blocks are selected based on different patches. In this random block, a lacquer envelope They are placed in the heart research center of Dr. Heshmat Hospital in Rasht. On the basis of daily visits, after the study, the blocks are hidden from the envelope, and according to the corresponding block of the day, patients are assigned randomly in one of the intervention groups and the group. N/A Angiography. Intervention 1: Intervention group: The patients in the intervention group are، immediately after covered with clear dressing، a cold pack with a temperature of 15 to 18 °C during 2 hours( any period for 20 minutes with 10 minute intervals) Will be applied on the place. Intervention 2: Control group: The patients will receive routine care included the use of sandbags is 3-4 kg to 4 hours. Yes - There is a plan to make this available What will be shared: Total of data is Shareable after unidentifiable the people When: Start the access period 6 months after printing the results To whom: Only for researchers working in academic and scientific institutions Conditions: Meta analysis Where to obtain: Dr Nazila Javadi Guilan University of Medical Sciences. Shahid Beheshti Nursing and Midwifery School of Rasht How to obtain: contact by email Comments:
public Fariba Abrahimi
College of Nursing and Midwifery, Student street, Dr Beheshti ave, Rasht, Guilan, Iran
Rasht Iran (Islamic Republic of) 39841-41469 +98 13 3355 5056 faribaebrahimishalmani65@Yahoo.com Rasht University of Medical Sciences scientific Nazila Javadi
College of Nursing and Midwifery, Student street, Dr Beheshti ave, Rasht, Guilan, Iran
Rasht Iran (Islamic Republic of) 39841-41469 +98 13 3355 5056 n.javadip@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Signing written informed consent Older than 18 years old Perform angiography via femoral artery Not sensitive to cold No active bleeding in the femoral area during the procedure and before the catheter withdrawal Not experiencing lower back pain before hospitalization Ability to understand persian language No psychiatric disorders No any problems with seeing or hearing and proper time and place orientation No history of treatment with thrombolytic drugs and bleeding disorder for less than 6 monts Having a natural range of coagulation tests results in a pre-angiographic case No use sedative duration 24 hourse 18 years no limit Both The occurrence of any conditions that may lead to impairment in the care process diastolic or systolic blood pressure higher than 110 and 190 mm Hg Prevention Prevention Intervention group: The patients in the intervention group are، immediately after covered with clear dressing، a cold pack with a temperature of 15 to 18 °C during 2 hours( any period for 20 minutes with 10 minute intervals) Will be applied on the place Control group: The patients will receive routine care included the use of sandbags is 3-4 kg to 4 hours Vascular complication. Timepoint: Immediately after covered with clear dressing every 15 minute in first hour every 30 minute in the second hour and every hour to six hours. Method of measurement: A mount of bleeding is measured with weight of blood loaded gauze by balance with Milliliter. The borders of hematoma measures pulpable mass on angiography puncture site which measered by teransparent ruler and ecchgmosis any color change (blue purple)considered to be. Back pain. Timepoint: Immediately after covered with clear dressing ،4،6 and 24 after angiography procedure. Method of measurement: Visual analogue scales (VAS). Research and Technology Deputy of Guilan University of Medical Sciences Approved 2018-12-16 Ethics committee of Guilan University of Medical Sciences Eastern Shahid Beheshti Boulvard, Vice Chancellor for research of Guilan University of Medical Sciences Rasht Guilan Iran (Islamic Republic of)