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IRCT20110524006582N37 IRCT 2023-03-09 Tabriz University of Medical Sciences The effect of topical ointment of Propolis on severity of episiotomy pain and wound healing The effect of topical ointment of Propolis on severity of episiotomy pain and wound healing: a randomized controlled trial 2023-03-13 anticipated 72 Complete https://irct.ir/trial/68181 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be done based on the purpose, the sequence of allocation in the intervention groups will be using a computer randomization program and with an allocation ratio of 1:1. In order to hide the allocation (allocation concealment), the type of ointment for each participant (drug or placebo) will be determined by a person not involved in the study using a randomizer, and a numbered label will be placed on the ointments, Blinding description: Participants, researcher and data analyst will be blinded. Both drug and placebo will be completely similar in terms of color, size and shape and will be presented in similar packages. In addition to the person determining the sequence of placement of people in the groups, the only person who will know the type of drug prescribed will be the research assistant, and the participants, researcher, data collectors and analysts will not be informed. 3 Condition 1: Severity of episiotomy pain. Condition 2: Episiotomy wound healing. Intervention 1: Intervention group: Participants in the intervention group will use 2 cm (1 knuckle length) ointment on the ٍEpisiotomy site twice a day, 12 hours apart, for ten days. The contents of the ointment will include Propolis and Oserin (Vaseline and a little Lanolin). Propolis will be made from Royal Shahd Pirlanta bee products company, which is a beehive breeding place in Azerbaijan region, and Oserin will be made from Dr. Shahtalebi cosmetic company. Intervention 2: Control group: Participants in the control group will use 2 cm (1 knuckle length) ointment on the episiotomy site 2 times a day, 12 hours apart, for ten days. The prepared ointment base will be used as a placebo ointment without Propolis. If there is a need to adjust the color of the ointment, the approved pharmaceutical color will be used to match the color of the placebo and Propolis ointment. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participants data is confidential.
public Masoomeh Rafat Nia
Shariati street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3478 5229 Rafatniamasume@gmail.com Tabriz University of Medical Sciences scientific Mahin Kamali Fard
Nursing and Midwifery school, Shariati street
Tabriz Iran (Islamic Republic of) 9876598765 +98 41 3524 5181 Kamalifardm@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Gravid one and two women Living in Tabriz city Willingness and possibility of the mother to go to Alzahra and Taleghani hospitals on the 10th day Vaginal delivery with mediolateral incision no limit no limit Female Prolonged rupture of the amniotic sac (more than 18 hours) Use of special drugs such as anti-inflammatory and anticoagulant drugs Addiction to alcohol or drugs History of diseases interfering with wound healing such as systemic, cardiac, renal, pulmonary diseases, coagulation disorder, immunodeficiency, connective tissue disorder, diabetes, anemia, mental illness, hemophilia (based on medical records) Abnormal postpartum bleeding Preterm labor Allergy to propolis Large or extended episiotomy (third or fourth degree tear and episiotomy cut length greater than 3-4 cm) History of surgery or visible lesions in the perineum Severe anemia (hemoglobin less than 7 grams per deciliter) Other tears in addition to episiotomy, such as urethral tears Non-continuing cooperation of participants Incomplete participation that is not possible to achieve results Treatment - Other Placebo Intervention group: Participants in the intervention group will use 2 cm (1 knuckle length) ointment on the ٍEpisiotomy site twice a day, 12 hours apart, for ten days. The contents of the ointment will include Propolis and Oserin (Vaseline and a little Lanolin). Propolis will be made from Royal Shahd Pirlanta bee products company, which is a beehive breeding place in Azerbaijan region, and Oserin will be made from Dr. Shahtalebi cosmetic company. Control group: Participants in the control group will use 2 cm (1 knuckle length) ointment on the episiotomy site 2 times a day, 12 hours apart, for ten days. The prepared ointment base will be used as a placebo ointment without Propolis. If there is a need to adjust the color of the ointment, the approved pharmaceutical color will be used to match the color of the placebo and Propolis ointment. Pain level of episiotomy. Timepoint: At the beginning of the study (before the start of the intervention) and on the 10th day after delivery. Method of measurement: Visual Analogue Scale. Episiotomy wound healing rate. Timepoint: At the beginning of the study (before the start of the intervention) and on the 10th day after delivery. Method of measurement: Redness, Edema, Ecchymosis, Discharge, Approximation scale. Tabriz University of Medical Sciences Approved 2023-01-28 Medical Ethics Committee of Tabriz University of Medical Sciences Research department, third floor, central construction number 2, Tabriz university of medical science, Azadi avenue Tabriz East Azarbaijan Iran (Islamic Republic of)