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IRCT20230501058041N1 IRCT 2023-06-20 Mashhad University of Medical Sciences Investigating the effect of apricot kernel oil cream on pain and healing of episiotomy Investigating the effect of apricot kernel oil cream on pain intensity and episiotomy wound healing in primiparous women 2023-07-01 anticipated 76 Complete https://irct.ir/trial/70525 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocked random assignment In this study, permutation blocks method will be used to generate the sequence of random assignment of people to the studied groups. Random allocation sequence of people will be done using Random Allocation Software and block size of four. The permutation block method is one of the random allocation methods in which each block is selected according to the number of studied groups. In this study, there are six blocks AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5) and BAAB (6). One of the blocks is randomly selected. If the first block, AABB, is selected, the first and second people are assigned to group A, and the third and fourth people are assigned to group B, and this process continues until all the samples are assigned. The characteristic of this method is that the two study groups will have equal numbers. Allocation Concealment method Random Allocation Software Sealed envelopes are used to hide the assignment. Based on the order of entry of the research units, the envelopes will be opened in order and the assigned group will be revealed. In order to hide the allocation, opaque envelopes numbered consecutively (in the order of allocation sequence) were used, which will contain 2 bottles containing the solution. Medicines will be placed in the envelopes based on the random sequence of allocation by a person not involved in the research. Entering people into the study and delivering the envelopes from number 1 to 120 will be done by the researcher himself, Blinding description: The drug and placebo are blinded by the pharmacist and the researcher and the participants will not know the contents of the package. The desired cream is prepared in containers of one shape and one color of 30 grams, and coding (A, B) will be done on the containers by a pharmacist consultant. 38 participants in each group will receive cream A or B randomly. 2-3 Condition 1: Episiotomy wound. Condition 2: Episiotomy wound. Condition 3: Episiotomy wound. Intervention 1: Intervention group: After random allocation, the intervention group received the cream containing 10% apricot kernel oil, which was prepared and filled in 30 gram tubes with code A or B under the supervision of professors of the Faculty of Pharmacy of Mashhad University of Medical Sciences (oil extraction with a cold press machine). Local face and every 12 hours, 2 cm of the product is consumed in the first 10 days after delivery. Intervention 2: Control group: The control group will be placed in the placebo group after random allocation. The placebo is a standard cold cream without apricot kernel oil and as a simple cream base, which is similar to the drug in terms of shape and can only be distinguished by the code (by the pharmacist) and the method of use will be the same as the drug group. 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 Decision after completion of work
public Mahboobeh Firoozi
Faculty of Nursing and Midwifery, Ibn Sina Street, Doctor's Crossroad, University of Mashhad, Khorasan Razavi
Mashhad Iran (Islamic Republic of) 9137913199 05138591511-3 FirooziM@mums.ac.ir Mashhad University of Medical Sciences scientific Mahboobeh Firoozi
Faculty of Nursing and Midwifery, Ibn Sina Street, Doctor's Crossroad, University of Mashhad, Khorasan Razavi
Mashhad Iran (Islamic Republic of) 9137913199 05138591511-3 FirooziM@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The participant has informed consent. Age between 18 and 35 years old. Must be literate and a resident of Mashhad. The gestational age should be 37 to 42 weeks. Do not have a history of sensitivity or allergy to topical medications in the past Do not use drugs effective on wound healing (glucocorticoids, anticoagulants, immunosuppressants, broad-spectrum antibiotics, and chemotherapy). Do not be addicted to drugs. Not diabetic Rupture of water bag not more than 18 hours Singleton pregnancy No history of surgery or visible lesions in the perineum. Body mass index should be between 19.8 and 30 18 years 35 years Female The baby's weight should be more than 4000 grams. Have abnormal bleeding after delivery. Has not used the cream regularly. Allergies and infections Happening a new trauma. Do not refer for follow up. Patients with a disease need to be prescribed antibiotics. Does not want to continue participating in the research. Have sex in the first ten days. Manipulate again after episiotomy repair. Have a 3rd and 4th grade tear of the perineum Have postpartum fever. Childbirth with tools. The placenta should be removed by hand. There is a hematoma in the episiotomy area The first stage of labor is more than 14 hours, the second stage is more than 2 hours, and the third stage is more than one hour The baby should be admitted to the NICU O70 070.0 O70.1 Episiotomy extended by laceration: Perineal laceration during delivery First degree perineal laceration during delivery Second degree perineal laceration during delivery Treatment - Drugs Placebo Intervention group: After random allocation, the intervention group received the cream containing 10% apricot kernel oil, which was prepared and filled in 30 gram tubes with code A or B under the supervision of professors of the Faculty of Pharmacy of Mashhad University of Medical Sciences (oil extraction with a cold press machine). Local face and every 12 hours, 2 cm of the product is consumed in the first 10 days after delivery Control group: The control group will be placed in the placebo group after random allocation. The placebo is a standard cold cream without apricot kernel oil and as a simple cream base, which is similar to the drug in terms of shape and can only be distinguished by the code (by the pharmacist) and the method of use will be the same as the drug group Reducing the pain intensity score at the episiotomy site based on the visual pain scale tool. Timepoint: The first, fifth and 10 to 14 days after delivery. Method of measurement: Visual tool for pain. Reducing the redness score of the episiotomy wound based on the Rida tool. Timepoint: The first, fifth and 10 to 14 days after delivery. Method of measurement: Rida too. Reduction of episiotomy wound edge edema score based on Rida tool. Timepoint: The first, fifth and 10 to 14 days after delivery. Method of measurement: Rida too. Reduction of episiotomy wound bruising score based on Rida tool. Timepoint: The first, fifth and 10 to 14 days after delivery. Method of measurement: Rida too. Reduction of episiotomy wound edge cohesion score based on Rida tool. Timepoint: The first, fifth and 10 to 14 days after delivery. Method of measurement: Rida too. Reducing the episiotomy wound discharge score based on the Rida tool. Timepoint: The first, fifth and 10 to 14 days after delivery. Method of measurement: Rida too. Wound healing based on the reduction of the mean total score of the Rida instrument. Timepoint: The first, fifth and 10 to 14 days after delivery. Method of measurement: Rida tool, observation of signs of infection (redness, secretion or purulent exudate, swelling of wound margin. Mashhad University of Medical Sciences Approved 2023-05-30 Ethics Committee of Mashhad University of Medical Sciences Khorasan Razavi, Mashhad, University Street, Central Organization of Qurashi Building University Mashhad Razavi Khorasan Iran (Islamic Republic of)