]>
IRCT20100130003226N19 IRCT 2022-11-28 Shahid Beheshti University of Medical Sciences Evaluation the effect of Malva sylvestris L extract ointment on pain intensity and incision of during delivery wound healing in primiparous women Comparison of the effect of Malva sylvestris L extract ointment and placebo on pain intensity and episiotomy wound healing in primiparous women 2023-01-21 anticipated 112 Complete https://irct.ir/trial/66636 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: It is available (simple) and goal based. In this way, all patients who are eligible for the study will be screened. The delivery of medicine to the patients in a box containing several cards that are evenly written in the English alphabet "A and B" with the placebo and Malva sylvestris L ointment code (researcher unaware of the content of the ointments) we match and patients randomly choose a card and receive the medicine according to the letters on the card, Blinding description: This study is a kind of triple-blind randomized controlled clinical trial. At the diagnostic stage, the demographic forms and obstetric and delivery questionnaire are not completed and the patient's name is not written. At the stage of giving medicine to the patient, a placebo and Malva-sylvestris-L ointment are marked with the English letter A and B coded by the pharmacist. The researcher is not aware of the contents of the ointments and the patient also randomly selects one of the placeboes or Malva-sylvestris-L ointments the statistic professor is also unaware of the intervention and control groups. 3 Episiotomy. Intervention 1: Intervention group: Intervention group: Uses 3% Malva sylvestris L ointment for 10 days (daily) at a rate of two centimeters, on episiotomy wound. This ointment is produced at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Initial assessment of pain intensity and wound healing is done before the intervention, 24 hours after the intervention and then on the fifth and tenth days. Intervention 2: Control group: Control group: Use placebo ointment (quite similar to Malva sylvestris L ointment) for 2 days (daily) at 2 cm, on episiotomy ulcer. This ointment is produced at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Initial assessment of pain intensity and wound healing is done before the intervention, 24 hours after the intervention and then on the fifth and tenth days. 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 There is no more information.
public Mahrokh Dolatian
School of Nursing and Gynecology Department, In front of Shaheed Rajaee Heart Hospital, The intersection of Niayesh, Vali asr street, Tehran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 mhdolatian@gmail.com Shahid Beheshti University of Medical Sciences scientific Dr. Mahrokh Dolatian
Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 mhdolatian@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Married women aged 18 to 35 years primiparous Being Iranian Gestational age between 37 to 42 weeks No smoking, alcohol and drugs Being literate in reading and writing Having a single fetus with cephalic presentation Fetal weight between 2500 and 4000 gr Body Mass Index (BMI) between 18.5 and 25 Vaginal delivery with mediolateral episiotomy The normality of the first, second and third stages of labor 18 years 35 years Female Amniotic sac rupture more than 24 hours Allergy to Malva sylvestris L ointment Having fever, puerperal infection and hematoma Infant hospitalization at Neonatal Intensive Care Unit Having postpartum hemorrhoids or fissures Having sex in the first ten days after delivery O70 Perineal laceration during delivery Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Uses 3% Malva sylvestris L ointment for 10 days (daily) at a rate of two centimeters, on episiotomy wound. This ointment is produced at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Initial assessment of pain intensity and wound healing is done before the intervention, 24 hours after the intervention and then on the fifth and tenth days. Control group: Control group: Use placebo ointment (quite similar to Malva sylvestris L ointment) for 2 days (daily) at 2 cm, on episiotomy ulcer. This ointment is produced at the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Initial assessment of pain intensity and wound healing is done before the intervention, 24 hours after the intervention and then on the fifth and tenth days. Episiotomy wound healing. Timepoint: Before the intervention, the first 24 hours, 5 and 10 days after treatment. Method of measurement: REEDA scale assess 5 items such as Redness, Edema, Ecchymoses, Discharge from the wound and Approximation of the perineal tissues. Episiotomy wound pain intensity. Timepoint: Before the intervention, the first 24 hours, 5 and 10 days after treatment. Method of measurement: The visual pain scale (VAS) is a tool for measuring the intensity of pain, which is a 10 cm ruler with eleven numbers. Shahid Beheshti University of Medical Sciences Approved 2022-10-31 Ethics Committee of Pharmacy, Nursing and Midwifery Faculties of Shahid Beheshti University of Medic Block A, 13th floor, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran Street, between South Flamak and Zarafshan, Quds Town (West), Tehran. Tehran Tehran Iran (Islamic Republic of)