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IRCT20210217050394N1 IRCT 2021-03-08 Mashhad University of Medical Sciences Evaluation of the effect of evening primrose oil capsules on postpartum pain in multiparous women Evaluation of the effect of evening primrose oil capsules on postpartum pain in multiparous women 2021-03-10 anticipated 90 Complete https://irct.ir/trial/54394 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling in the midwifery clinic of Umm Al-Banin hospital will be done in an easy method, based on the inclusion and exclusion criteria, and using a simple randomization method, random allocation of samples will be done in different groups. Randomization method will be as follow: It is performed that the assignment sequence will be written before the beginning of the research. Given that 3 groups will be studied and each letter will be assigned to a group (A evening primrose capsule, B placebo and C control group with routine care). Randomization will be performed using Research Randomizer software, then inside the sealed and opaque packages, the type of intervention will be written based on the allocation sequence and packages will be numbered, Blinding description: Capsules will be encoded by the pharmacist. The capsules will be divided and numbered in opaque and sealed envelopes. Researchers and mothers will be unaware of group codes. 3 Postpartum pain. Intervention 1: Intervention group: 1000 mg evening primrose oil capsule and made by Barij Essential Oil Company, available in the market, based on previous studies in the field of gynecology and obstetrics and with the advice of a pharmacist, its number and amount of use will be determined and considered for intervention at least 2 hours after delivery. The first dose will be given and the pain will be measured and recorded again one hour after taking the medicine. The intervention group will receive the capsule 4 times every 8 hours. At each intervention, pain intensity will be measured and recorded one hour before and one hour after. One hour after each intervention, if the pain will persist and the mothers request painkillers, a 500 mg acetaminophen tablet is given and recorded. Intervention 2: Placebo group: 1000 mg capsule containing paraffin, very similar to evening primrose capsule, at least 2 hours after delivery, the first dose will be given and one hour after taking the drug, the pain will be measured and recorded again. The group will receive the capsule 4 times every 8 hours. At each intervention, pain intensity will be measured and recorded one hour before and one hour after. One hour after each intervention, if the pain will persist and the mother requests painkillers, an acetaminophen 500 mg tablet is given and recorded. Intervention 3: Control group: In the control group, no intervention will be performed and if pain is expressed, they will receive routine analgesia (acetaminophen 500 mg). 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 Yes. There is a plan to publish.
public Maryam Amin
School of Nursing and MidwiferyMashhad Ibn Sina St.
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 AminM982@mums.ac.ir Mashhad University of Medical Sciences scientific Samira Ebrahimzadeh Zagmi
Mashhad, Ibn Sina St., School of Nursing and Midwifery
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 EbrahimzadehZS@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Being Iranian mother age between 18-35 years singleton pregnancy with gestational age 37-42 weeks normal delivery live and seemingly healthy baby baby weight between 4000-2500 grams Normal delivery gravid 3-5 No use of narcotics and spinal and epidural anesthesia during labor No cesarean section or previous uterine surgery The second and third stages of normal delivery Absence of medical disease and no grade 3 and 4 perineal and vaginal tears Lack of sensitivity to medicinal plants and acetaminophen Start breastfeeding until the first two hours after delivery and continue breastfeeding Pain intensity (based on visual scale) 4 and more within 2 hours after delivery 18 years 35 years Female The mother's unwillingness to participation Allergy to medicinal plants Medical and midwifery problems First pregnancy Multiplication Mother age should not be between 18-35 Z39 Encounter for maternal postpartum care and examination Treatment - Drugs Treatment - Drugs Other Intervention group: 1000 mg evening primrose oil capsule and made by Barij Essential Oil Company, available in the market, based on previous studies in the field of gynecology and obstetrics and with the advice of a pharmacist, its number and amount of use will be determined and considered for intervention at least 2 hours after delivery. The first dose will be given and the pain will be measured and recorded again one hour after taking the medicine. The intervention group will receive the capsule 4 times every 8 hours. At each intervention, pain intensity will be measured and recorded one hour before and one hour after. One hour after each intervention, if the pain will persist and the mothers request painkillers, a 500 mg acetaminophen tablet is given and recorded. Placebo group: 1000 mg capsule containing paraffin, very similar to evening primrose capsule, at least 2 hours after delivery, the first dose will be given and one hour after taking the drug, the pain will be measured and recorded again. The group will receive the capsule 4 times every 8 hours. At each intervention, pain intensity will be measured and recorded one hour before and one hour after. One hour after each intervention, if the pain will persist and the mother requests painkillers, an acetaminophen 500 mg tablet is given and recorded. Control group: In the control group, no intervention will be performed and if pain is expressed, they will receive routine analgesia (acetaminophen 500 mg). Postpartum pain in multiparous women. Timepoint: Beginning and end of the study and during the first 24 hours of labor - every 8 hours - one hour before and one hour after the intervention. Method of measurement: McGill Pain Questionnaire and Visual Pain Scale (VAS). Mashhad University of Medical Sciences Approved 2021-01-26 Ethics Committee of Mashhad University of Medical Sciences Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Intersection, Ibn Sina St., School of Nursing and Midwifery Mashhad Razavi Khorasan Iran (Islamic Republic of)