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IRCT20220816055724N1 IRCT 2022-09-02 Arak University of Medical Sciences The Effect of Rosa damascene and Phenytoin Cream on pain and episiotomy wound healing Investigating the Effect of Rosa damascene and Phenytoin Cream on pain and episiotomy wound healing in primiparous women 2022-09-23 anticipated 120 Complete https://irct.ir/trial/65329 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To create a randomization sequence or Random sequence generation, at first, each of the 120 volunteers who meet the criteria for entering the study are given codes from 001 to 120, then using a table of random numbers and choosing the path from top to bottom and keeping in mind Numbers 001 to 040 for the intervention group of rose flower cream or A, numbers 041 to 080 for the intervention group of phenytoin cream or B, and numbers 081 to 120 for the control group or placebo cream or C, the researcher puts his hand on one of the numbers and It moves in the predetermined direction and records the obtained number and assigns it to different groups according to the default type. Then, for the second stage of allocation concealment, three batches of creams are prepared by the traditional medicine doctor in the laboratory in the same shape, color and smell with Vaseline base in each batch in the same 60 gram white tubes and with the name A is prepared for rose cream, B for phenytoin cream and C for placebo cream. In the third stage of randomization or implementation 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, Blinding description: Rosa damascene cream and placebo cream based on Vaseline prepared by a traditional medicine pharmacist, as well as phenytoin cream prepared by Amin Pharmaceutical Company at the Traditional Medicine Research Center will be filled in 60 gram white tubes with the same names as A, B and C. and will be provided to the researcher to conduct research. The researcher, the participant, the outcome assessor and the results analyzer (the results are coded) and the data safety and monitoring committee will not know the contents of the tubes until the end of the study and the announcement of the results. 3 Condition 1: Pain. Condition 2: wound healing. Intervention 1: Intervention group: Rosa damascene cream. cream will be prepared by a traditional medicine pharmacist based on the formulation of Iranian traditional medicine books; In this way, after identifying and ensuring the authenticity of the raw material and some relevant quality factors, the components of the composition are standardized and the samples are controlled from a microbial point of view, and then the relevant cream will be prepared from the extract of this medicinal plant with Vaseline base and inside 60 gram tubes will be poured. These drugs will be prescribed to patients 3 times a day for 10 days. Intervention 2: Intervention group: Phenytoin Cream. The cream is prepared by Amin Pharmaceutical Company and is prepared in the traditional medicine center by a traditional medicine pharmacist in 60 mg white tubes similar to other creams. These drugs will be prescribed 3 times a day for 10 days in the episiotomy area. Intervention 3: Control group: Placebo cream. Vaseline-based cream will be prepared similar to the creams of the intervention group and then will be poured into 60 gram tubes. This medicine will be prescribed 3 times a day for 10 days in the episiotomy area. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is a privet data
public Fatemeh Shabani
Sardasht mojtamepayambarazam
Arak Iran (Islamic Republic of) 38481-7-6341 +98 86 3417 3520 fatemeshabani@yahoo.com Arak University of Medical Sciences scientific Dr Mehdi Salehi
Sardasht mojtamepayambarazam
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 Having at least reading and writing literacy perimiparus Age between 15-45 Body mass index (after delivery) between 18.5-30 kilograms per square meter 15 years 45 years Female Gestational age 37-42 , Cephalic presentation, one alive fetuse 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, disorder connective tissue, depression, malnutrition, mental illnesses, cancer) using 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 The duration of rupture of the Amionitic membran is not more than 18 hours Non-instrumental vaginal delivery with medial and lateral episiotomy incision having a history of previous injury or surgery and visible lesions in the perineum (genital warts, hemorrhoids) and persistent constipation (according to the patient's statement) Spontaneous removal of the placenta G89.18 O90.1 Other acute postprocedural pain Disruption of perineal obstetric wound Treatment - Drugs Treatment - Drugs Placebo Intervention group: Rosa damascene cream. cream will be prepared by a traditional medicine pharmacist based on the formulation of Iranian traditional medicine books; In this way, after identifying and ensuring the authenticity of the raw material and some relevant quality factors, the components of the composition are standardized and the samples are controlled from a microbial point of view, and then the relevant cream will be prepared from the extract of this medicinal plant with Vaseline base and inside 60 gram tubes will be poured. These drugs will be prescribed to patients 3 times a day for 10 days. Intervention group: Phenytoin Cream. The cream is prepared by Amin Pharmaceutical Company and is prepared in the traditional medicine center by a traditional medicine pharmacist in 60 mg white tubes similar to other creams. These drugs will be prescribed 3 times a day for 10 days in the episiotomy area. Control group: Placebo cream. Vaseline-based cream will be prepared similar to the creams of the intervention group and then will be poured into 60 gram tubes. This medicine will be prescribed 3 times a day for 10 days in the episiotomy area. Episiotomy wound pain. Timepoint: The effect of Rosa damascene cream, phenytoin and placebo on episiotomy pain on days 1, 5 and 10 after delivery (day 1, 5 and 10 after intervention). Method of measurement: Ruler method- Using the VAS questionnaire. Repair of episiotomy wound. Timepoint: The effect of Rosa damascene cream, phenytoin and placebo onepisiotomy wound healing on days 1, 5 and 10 after delivery (day 1, 5 and 10 after intervention). Method of measurement: Reeda questionnaire. Drug side effects. Timepoint: The effect of Rosa damascene cream, phenytoin and placebo on episiotomy Burning on days 1, 5 and 10 after delivery (day 1, 5 and 10 after intervention). Method of measurement: check list. Redness. Timepoint: The effect of Rosa damascene cream, phenytoin and placebo on episiotomy redness on days 1, 5 and 10 after delivery (day 1, 5 and 10 after intervention). Method of measurement: check list. Wheal. Timepoint: The effect of Rosa damascene cream, phenytoin and placebo on episiotomy wheal on days 1, 5 and 10 after delivery (day 1, 5 and 10 after intervention). Method of measurement: check list. Arak University of Medical Sciences Approved 2022-06-26 Ethics Committee of Arak University of Medical Sciences Alamlhoda Aenue Arak Markazi Iran (Islamic Republic of)