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IRCT20181208041892N1 IRCT 2018-12-26 Islamic Azad University The Effect of Nigella Sativa Oil on Phlebitis Evaluation of the Effect of Nigella Sativa Oil in the Prevention of Chemotherapy- Induced Phlebitis 2018-10-04 anticipated 60 Complete https://irct.ir/trial/35812 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: in this study, Research units based on simple randomization method were placed in intervention or control group. Using Lottery Cards: two Cards for intervention group and two other Cards for control group were considered. After putting the cards in a container, a card was selected by patients and according to the selected card, patients were placed in the intervention group or control group. Then, Selected Cards were added to the other Cards in the container and a Card was taking out by patients, again. This process was done in two groups until completing the number of samples, Blinding description: In this study, the patients have been blinded. In order to blind the study, the researcher was putting a cover on the container of Nigella Sativa oil, then the patients were unable to identify the oil name. N/A Phlebitis. Intervention 1: Intervention group: 5 drops of Nigella Sativa oil (prepared by the pharmacist) was rubbed around the area of intravenous chemotherapy injection, every 12 hours (morning and night before sleep), from the first day of chemotherapy up to third day, by researcher. Intervention 2: Control group: no intervention was done. Only the area of the catheters were assessed for any sign of phlebitis. Yes - There is a plan to make this available What will be shared: The total potential data can be shared after unidentifiable people When: Starting the access period from 1397 To whom: Niaz Behnamfar Conditions: The total potential data after unidentifiable people is for sharing analysis Where to obtain: niaaz.behnamfar@gmail.com How to obtain: Print in magazine Comments:
public Niaz Behnamfar
Shariati St., Khaghani St. - Islamic Azad University, Tehran Medical Sciences
Tehran Iran (Islamic Republic of) 1916893813 +98 21 2200 6660 Niaaz.Behnamfar@gmail.com Islamic Azad University scientific Dr. Zohreh Parsa Yekta
Zargandeh St., Southern Attary Moghaddam St., Knowledge Alley, Islamic Azad University, Tehran Medical Sciences
Tehran Iran (Islamic Republic of) 1916893813 +98 21 2200 6660 Zparsa@tums.ac.ir Islamic Azad University Iran (Islamic Republic of) Consciousness & Patient cooperation Age between 25-75 years Admitted to hospital with Gastrointestinal cancer (colon, rectum, esophagus, stomach) Chemotherapeutic management with 5-fluorouracil & Oxaloplatin & Leukovein or 5-fluorouracil & Cisplatin Catheterization into arm vein Application No. 20-22 catheter Unicut Company Instructions no received antibiotic & Non-steroidal anti-inflammatory drugs Without diabetes, Skin disorders and Autoimmune diseases Stable hemodynamic status Not addiction Hospitalized in the Oncology Ward of Tohid Hospital Without fever & neutropenia 25 years 75 years Both Unwillingness to be in the study Worsen the condition of patient during the study Incidence of allergic reactions during the study Acute infection T80.1 Vascular complications following infusion, transfusion and therapeutic injection Prevention Prevention Intervention group: 5 drops of Nigella Sativa oil (prepared by the pharmacist) was rubbed around the area of intravenous chemotherapy injection, every 12 hours (morning and night before sleep), from the first day of chemotherapy up to third day, by researcher. Control group: no intervention was done. Only the area of the catheters were assessed for any sign of phlebitis. Phlebitis. Timepoint: Every 12 hours over 72 hours after intervention. Method of measurement: observation, Visual Infusion Phlebitis Scale ( VIP). Pain, Erythema and Swelling. Timepoint: Every 12 hours over 72 hours. Method of measurement: Observation, Visual infusion phlebitis Scale (VIP). Islamic Azad University Approved 2018-03-07 The Ethics Committee of Islamic Azad University, Tehran Medical Branch Shariati St., Khaghani St. - Islamic Azad University, Tehran Medical Sciences Tehran Tehran Iran (Islamic Republic of)