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IRCT20220816055724N2 IRCT 2022-10-18 Arak University of Medical Sciences The effect of Arnebia euchchroma and Phenytoin Cream on pain and episiotomy wound healing Investigating the Effect of Arnebia euchchroma and Phenytoin Cream on pain and episiotomy wound healing in primiparous women 2022-09-23 anticipated 120 Complete https://irct.ir/trial/65633 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, with a sample size of 120 people, the participants were randomly placed into three groups of 40 people (two intervention groups and one control group),with using of the block permutation randomization method in order to balance the number of samples allocated in each group. , and with 6 people in each block, we arrange all possible blocks as follows: block 1: BCACAB and BBCACA block 2: and block 3: BCAABC ..... and so on for different sequences. We need 20 blocks for 120 people. We select these blocks from the above permutations using random allocation software, which is capable of generating a random sequence in the block method. For example, if number 1 is the first block and number 3 to be selected as the second block, the people who enter the study will be given BCACAB, BCAABC, in order from left to right, and finally they will be divided into three groups receiving drug A, drug B, and placebo (C), Blinding description: Creams of three batches are prepared by the traditional medicine doctor in the laboratory in the same shape and color and smell with Vaseline base in each batch in the same 60 gram white tubes and with the names A is prepared for Arnebia euchchroma cream, B for phenytoin cream and C for placebo cream. In the execution of the process the participant in the study, the person who created the random sequence, the person who examined the participants in terms of entry and exit criteria and enrolled them in the study, and the person who participated He has allocated the manufacturers to groups, the person who performs the data analysis and the researcher does not know about the allocation of groups and the type of drug in the creams is also known only to the manufacturer, who will not inform others of the results until the end of the analysis. 3 Condition 1: Pain severity. Condition 2: Wound healing. Intervention 1: Intervention group: Arnebia euchchroma cream is applied every 8 hours on days 1 to 10 after giving birth to the episiotomy wound after washing the perineum. Intervention 2: Intervention group: phnytoeen cream is applied every 8 hours on days 1 to 10 after giving birth to the episiotomy wound after washing the perineum. Intervention 3: Control group: Placebo cream cream is applied every 8 hours on days 1 to 10 after giving birth to the episiotomy wound after washing the perineum. No - There is not a plan to make this available Justification or reason for not sharing IPD is -
public Dr Medie Salehi
Medical Schoo Mojamae Payambar Azam Sardasht
Arak Iran (Islamic Republic of) 38481-7-6341 +98 86 3147 3520 daneshkadeha@arakmu.ac.ir Arak University of Medical Sciences scientific Dr Mehdie Salehi
Medical School Mojtame Payambar Azam Sardasht
Arak Iran (Islamic Republic of) 38481-7-6341 +98 86 3417 3520 daneshkadeha@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Normal pregnancy and delivery Age between 15-45 Primeparous Body mass index (after delivery) between 18.5-30 kilograms per square meter Having at least reading and writing literacy 15 years 45 years Female Gestational age below 37 weeks or above 42 weeks Suffering from diseases that interfere with wound healing (such as anemia, infection and wounds in the perineum, diabetes, blood pressure, skin, heart, kidney, lung diseases, coagulation disorder, immunodeficiency, hemophilia, connective tissue disorder, depression, malnutrition, mental illness, cancer) Taking drugs effective on wound healing by the mother (anticoagulants, antidepressants, antiepileptics), alcohol, smoking, glucocorticoids, immune system suppressors, antibiotics, and narcotics and psychotropic drugs, not doing chemotherapy The duration of rupture of the water bag more than 18 hours Instrumental vaginal delivery with medial or lateral episiotomy incision Non spontaneous removal of the placenta History of injury or previous surgery and visible lesions in the perineum (genital warts, hemorrhoids) and persistent constipation (according to the patient's statement) G89.28 O90.1 Other chronic postprocedural pain Disruption of perineal obstetric wound Treatment - Drugs Treatment - Drugs Placebo Intervention group: Arnebia euchchroma cream is applied every 8 hours on days 1 to 10 after giving birth to the episiotomy wound after washing the perineum. Intervention group: phnytoeen cream is applied every 8 hours on days 1 to 10 after giving birth to the episiotomy wound after washing the perineum. Control group: Placebo cream cream is applied every 8 hours on days 1 to 10 after giving birth to the episiotomy wound after washing the perineum. Pain severity. Timepoint: Days 1, 5 and 15 after delivery. Method of measurement: Using the VAS pain questionnaire and Disposable paper ruler. Wound healing. Timepoint: Days 1, 5 and 15 after delivery. Method of measurement: Using the Reeda pain questionnaire. Drug side effects. Timepoint: Days 1,5,15 after delivery. Method of measurement: Cheek list. Arak University of Medical Sciences Approved 2022-06-26 Ethics Committee Of Arak University of Medical Sciences Medical Science Of University Of Arak, Sardasht, Mojtamah Payambar Azam, Arak, Iran Arak Markazi Iran (Islamic Republic of)