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IRCT20120718010324N68 IRCT 2022-02-06 Tabriz University of Medical Sciences The effect of Nigella sativa oil on pain and healing of episiotomy The effect of Nigella sativa oil on pain and healing of episiotomy: a three-Blind randomized controlled trial 2022-01-29 anticipated 70 Complete https://irct.ir/trial/57977 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants in the study will be assigned to two groups (one group receiving Nigella Sativa gel and one group receiving placebo gel with the same protocol) by block randomization method with block sizes of 4 and 6 and a allocation ratio of 1: 1. To hide the Allocation (Allocation Concealment), the allocation sequence will be identified by a person not involved in the study using a randomizer software, and the Nigella Sativa gel and placebo gel will be placed in the same packages numbered sequentially, Blinding description: The participants, researcher and data analyst will be blinded in this study. Drug and placebo will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in the research. 3 Episiotomy wound healing. Intervention 1: Intervention group or treatment group: Black seed gel with a concentration of 15% will be prepared by the pharmacy department of Tabriz University of Medical Sciences in the laboratory of the Pharmacy School and it will be used by the participants three times a day in the amount of one fingertip at the episiotomy site without massage for a week. Intervention 2: Control group: Placebo of black seed gel (paraffin) with a concentration of 15% will be prepared by the pharmacy department of Tabriz University of Medical Sciences in the laboratory of the Pharmacy School and it will be used by the participants three times a day in the amount of one fingertip at the episiotomy site without massage for a week. 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 Participant data is confidential.
public Afsaneh Alizadeh
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947 +98 41 3479 6770 afsanehalizadeh072@gmail.com Tabriz University of Medical Sciences scientific Dr. Mojgan Mirghafourvand
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947 +98 41 3479 6770 mirghafourvand@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Delivery of a live and single fetus Not following a special diet (according to the woman) Willingness and possibility of the mother to visit the comprehensive women's center of Dr. Mahzad in Urmia on the 10th day no limit no limit Female Long-term rupture of the amniotic sac (more than 18 hours) Large or enlarged episiotomy History of pre-delivery vaginal examinations and manipulations Early vaginal bleeding after delivery Having severe anemia during pregnancy History of diseases that interfere with wound healing such as systemic, heart, kidney, lung, coagulation disorders, immunodeficiency, connective tissue disorders, diabetes, anemia, mental illness, hemophilia Using of specific medications (such as anti-inflammatory drugs and anticoagulants based on the patient's statements) Addiction to addictive and psychotropic substances (based on the woman's statements and case file) O90.1 Disruption of perineal obstetric wound Treatment - Drugs Placebo Intervention group or treatment group: Black seed gel with a concentration of 15% will be prepared by the pharmacy department of Tabriz University of Medical Sciences in the laboratory of the Pharmacy School and it will be used by the participants three times a day in the amount of one fingertip at the episiotomy site without massage for a week. Control group: Placebo of black seed gel (paraffin) with a concentration of 15% will be prepared by the pharmacy department of Tabriz University of Medical Sciences in the laboratory of the Pharmacy School and it will be used by the participants three times a day in the amount of one fingertip at the episiotomy site without massage for a week. Wound healing score. Timepoint: Before discharge and 10±1 days after intervention. Method of measurement: REEDA scale. Pain score. Timepoint: Before discharge and 10 ± 1 days after intervention. Method of measurement: Visual Analog Scale. Tabriz University of Medical Sciences Approved 2021-11-28 Ethics Committee of Tabriz University of Medical Sciences Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue Tabriz East Azarbaijan Iran (Islamic Republic of)