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IRCT2015032721547N1 IRCT 2015-06-14 Social determinants of health research center, Guilan university of medical sciences, Rasht, Iran Study of effect of subcutaneous enoxaparin sodium injection duration on incidence and extent of bruising at injection site in hospitalized patients. - Study of effect of subcutaneous enoxaparin sodium injection duration on incidence and extent of bruising at injection site in hospitalized patient. 2015-05-15 anticipated 112 Complete https://irct.ir/trial/18856 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention. N/A ٍBruising in site of enixaparin sodium injection. Intervention 1: Group A: Samples(n=56) will receive pre-filled syring of enoxaparin sodium 6000 IU (prepared by Alborzdarou company), subcutaneously in two sequence days and in two methods of 1 (drug injection in 10 seconds in the right upper quadrant of abdomen) at first day and 2 (injection for 20 seconds including drug injection in 10 seconds and waiting for10 seconds more before needle withdrawal in the right lower quadrant of abdomen) at second day (24 hours apart). Drug injection method and patient teaching content will be the same as group B, except its duration. A stopwatch will use to control the exact time.The Injected area will circled about 5 cm diameter by a waterproof pen by naming 1 for the method 1 and 2 for method 2. A trained researcher fellow without any knowledge about the groups and injection method will evaluate the injected sites for bruises incidence and extent in about 48 hours after each injection by a flexible ruler in mm. Intervention 2: Group B: Samples(n=56) will receive pre-filled syring of enoxaparin sodium 6000 IU (prepared by Alborzdarou company), subcutaneously in two sequence days and in two methods of 2 (injection for 20 seconds including drug injection in 10 seconds and waiting for10 seconds more before needle withdrawal in the right lower quadrant of abdomen) at first day and method 1 (drug injection) in 10 seconds in the right upper quadrant of abdomen) at second day (24 hours apart). Drug injection method and patient teaching content will be the same as group A, except its duration. A stopwatch will use to control the exact time.The injected area will circled about 5 cm diameter by a waterproof pen by naming 1 for the method 1 and 2 for method 2. A trained researcher fellow without any knowledge about the group and injection method will evaluate the injected sites for bruises incidence and extent 48 hours after each injection by a flexible ruler in mm.
public Shirin Jafroudi
Daneshjoo street, Western Beheshti Boulvard, Beheshti nursing and midwifery college
Rasht Iran (Islamic Republic of) 4146939814 +98 13 3355 5056 s_jafroudi@gums.ac.ir Beheshti nursing and midwifery college, Guilan university of medical sciences scientific Shirin Jafroudi
Beheshi nursing and midwifery college, Daneshjoo street, Western beheshti Boulvard
Rasht Iran (Islamic Republic of) 41469 -39841 +98 13 3355 5056 s_jafroudi@gums.ac.ir Nursing and midwifery beheshti college, Guilan university of medical sciences Iran (Islamic Republic of) Inclusion criteria: Patients being in the first 24 hours of hospitalization in cardiac care unit who need to remain hospitalized for at least another 48 hours; coagulation tests results within therapeutic range; written order for subcutaneous 6000 IU enoxaparin sodium in patients`record; no special treatments required (fibrinolytic therapy, angioplasty,...), widespread skin lesions on the right side of the abdomen or any blood and liver diseases and signing written consent form to participate in the study. Exclusion criteria: Any changes in drug order or dosage, discharge before data selection time duration and death of a patient . 18 years 90 years Both T81.0 Hemorrhage in any site resulting from a procedure Prevention Prevention Group A: Samples(n=56) will receive pre-filled syring of enoxaparin sodium 6000 IU (prepared by Alborzdarou company), subcutaneously in two sequence days and in two methods of 1 (drug injection in 10 seconds in the right upper quadrant of abdomen) at first day and 2 (injection for 20 seconds including drug injection in 10 seconds and waiting for10 seconds more before needle withdrawal in the right lower quadrant of abdomen) at second day (24 hours apart). Drug injection method and patient teaching content will be the same as group B, except its duration. A stopwatch will use to control the exact time.The Injected area will circled about 5 cm diameter by a waterproof pen by naming 1 for the method 1 and 2 for method 2. A trained researcher fellow without any knowledge about the groups and injection method will evaluate the injected sites for bruises incidence and extent in about 48 hours after each injection by a flexible ruler in mm. Group B: Samples(n=56) will receive pre-filled syring of enoxaparin sodium 6000 IU (prepared by Alborzdarou company), subcutaneously in two sequence days and in two methods of 2 (injection for 20 seconds including drug injection in 10 seconds and waiting for10 seconds more before needle withdrawal in the right lower quadrant of abdomen) at first day and method 1 (drug injection) in 10 seconds in the right upper quadrant of abdomen) at second day (24 hours apart). Drug injection method and patient teaching content will be the same as group A, except its duration. A stopwatch will use to control the exact time.The injected area will circled about 5 cm diameter by a waterproof pen by naming 1 for the method 1 and 2 for method 2. A trained researcher fellow without any knowledge about the group and injection method will evaluate the injected sites for bruises incidence and extent 48 hours after each injection by a flexible ruler in mm. The incidence of bruising in site of enoxaparin sodium injection. Timepoint: 48 hours after intervention. Method of measurement: Recording the observed bruising in prepared form. The extent of bruising in area of Enoxaparin sodium in Milimeter. Timepoint: 48 hours after intervention. Method of measurement: Recording the bruising extent (by flexible ruler in milimeter) in prepared form. Social determinants of health research center, Guilan university of medical sciences, Rasht, Iran Approved 2015-03-17 Ethics committee of Guilan University of Medical Sciences ٍEastern Shahid Beheshti Boulvard, Vice Chancellor for research of Guilan University of Medical Sciences Rasht Iran (Islamic Republic of)