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IRCT20180701040297N2 IRCT 2019-03-25 Research and Technology Deputy of Guilan University of Medical Sciences The Effect of Topical Sesame Oil on Severity of Pain in Patients with Limb Trauma Assessing the Effect of Topical Sesame Oil on Severity of Pain in Patients with Limb Trauma 2019-04-09 anticipated 120 Complete https://irct.ir/trial/37378 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Gradually and in the event of having criteria for entering the study, the samples are allocated to 2 groups of intervention and placebo by randomized blocking method based on categories of trauma size (<100 cm2 />100 cm2) and age (18-40 years / 41-60 years old), Blinding description: The study is a randomized three-blind randomized clinical trial. researchers, patients and statisticians are not aware of the study groups. Sesame oil and placebo bottles are coded by research colleagues. They are given to the main researcher and patient no name and with code. Based on the specified codes, the information is entered into the software and analyzed by the statistics specialist. 3 Patients are traumatized. Intervention 1: Intervention group: After washing the area with normal saline, sesame oil (produced by Farabi Pharmaceutical Company) is poured on the area and then a circular massage is given with fingertip for 5 to 7 minutes. This intervention is done twice a day at home by patient and lasts for three days. Intervention 2: Control group: After washing the area with normal saline, placebo oil (A similar solution to the taste, color and appearance of sesame oil produced by Farabi Pharmaceutical Company) is poured on the area and then a circular massage is given with fingertip for 5 to 7 minutes. This intervention is done twice a day at home by patient and lasts for three days. Yes - There is a plan to make this available What will be shared: All data is shared after the people became unidentifiable 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 with email Comments:
public Mina Kafash Mohammadjani
College of Nursing and Midwifery, Daneshjoo street, Dr Beheshti highway
RASHT Iran (Islamic Republic of) 39841-41469 +98 13 3355 5056 M.kafash.1359@gmail.com Guilan University of Medical Sciences scientific Nazila Javadi
College of Nursing and Midwifery, Daneshjoo street, Dr Beheshti highway
RASHT Iran (Islamic Republic of) 39841-41469 +98 13 3355 5056 n.javadi@gums.ac.ir Guilan University of Medical Sciences Iran (Islamic Republic of) the patients 18-60 years non-penetrating trauma of the upper or lower extremities occurrence of trauma between one to six hours prior to referral pain score 3-6 on visual analogue scale full consciousness 18 years 60 years Both The presence of fractures in the injured limb The presence of bleeding at the site of the trauma dislocation of the injured limb amputation of the injured limb The presence of foreign body at the site of the trauma The presence of neurological damage in trauma location The presence of fever history of sensitivity or allergy to sesame Treatment - Other Placebo Intervention group: After washing the area with normal saline, sesame oil (produced by Farabi Pharmaceutical Company) is poured on the area and then a circular massage is given with fingertip for 5 to 7 minutes. This intervention is done twice a day at home by patient and lasts for three days. Control group: After washing the area with normal saline, placebo oil (A similar solution to the taste, color and appearance of sesame oil produced by Farabi Pharmaceutical Company) is poured on the area and then a circular massage is given with fingertip for 5 to 7 minutes. This intervention is done twice a day at home by patient and lasts for three days. Pain. Timepoint: The pain is totally evaluated 7 times; before the intervention on the first day and 30 minutes after each intervention for 3 days(Twice a day). Method of measurement: The Visual Analogue Scale is used to measure the severity of pain that includes a continuous line with two initial and end points of zero to 10; Zero means no pain and 10 means the maximum pain intensity. The amount of analgesic received during the intervention. Timepoint: At the end of the study. Method of measurement: Patient's document. Research and Technology Deputy of Guilan University of Medical Sciences Approved 2019-02-04 Ethics committee of Guilan University of Medical Sciences Eastern Shahid Beheshti Boulvard rasht Guilan Iran (Islamic Republic of)