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IRCT20160630028717N3 IRCT 2022-04-28 Vice Chancellor for Research and Technology of Guilan University of Medical Sciences Comparing the effect of Olea and Alpha ointment on episiotomy wound healing in nulliparous women Comparing the effect of Olea and Alpha ointment on episiotomy wound healing in nulliparous women: a randomized double-blind placebo-controlled trial 2022-05-20 anticipated 132 Complete https://irct.ir/trial/62287 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, all eligible individuals will be equally allocated into three Olea, Alpha and placebo ointment groups by blocked randomization with a size of 6 blocks (by the statistical consultant of this project). Allocation of sample to groups will be done by online randomization service, Sealed Envelope Ltd and for allocation concealment will be used by Sequentially-Numbered, Opaque, Sealed Envelopes (SNOSE), Blinding description: This study will be double blind and the participants and the investigator will be unaware of the content of ointment inside these packages. For blinding, the pharmacist colleague will pack the Olea, Alpha, and placebo ointments in the same shape and size opaque packages and tag the specific code based on random block allocation without the intervention and knowledge of the investigator. Then, these packages will be delivered to investigator. Investigator/student will allocate the participants in each one of the three groups based on inclusion criteria and blocked randomization and provide these packages to the participants for free of charge. 3 Episiotomy wound healing. Intervention 1: Intervention group: The Olea ointment will be considered as the intervention group. In this group, the first intervention will be performed 4 hours after the episiotomy by the mother in the presence of the researcher. After washing and drying the hands and perineal area, the mother will be advised to apply a fingertip (about 2 cm or 2 g) of the ointment to the episiotomy wound in the presence of the researcher, and after about 2 minutes use a clean sanitary pad and continue every 8 hours for up to 10 days. Olea ointment containing equal proportions of honey (33.4%), olive oil (33.3%) and sesame oil (33.3%) in 30 gram packages made by Isatis Shargh Farateb Research Scientific Company located in Yazd based on the relevant formula and will be provided to the researcher. Intervention 2: Intervention group: The Alpha ointment will be considered as the intervention group. In this group, the first intervention will be performed 4 hours after the episiotomy by the mother in the presence of the researcher. After washing and drying the hands and perineal area, the mother will be advised to apply a fingertip (about 2 cm or 2 g) of the ointment to the episiotomy wound in the presence of the researcher, and after about 2 minutes use a clean sanitary pad and continue every 8 hours for up to 10 days. Alpha ointment containing beeswax, flavonoids, unsaturated fatty acids and the active ingredient of henna and turmeric is currently made in 30 gram packages by Alpha Development Company in Iran and is available in pharmacies. This ointment will be purchased at the pharmacy. Intervention 3: Control group: The placebo ointment (same color and shape with the Olea and Alpha ointments) will be considered as the control group. In this group, the first intervention will be performed 4 hours after the episiotomy by the mother in the presence of the researcher. After washing and drying the hands and perineal area, the mother will be advised to apply a fingertip (about 2 cm or 2 g) of the ointment to the episiotomy wound in the presence of the researcher, and after about 2 minutes use a clean sanitary pad and continue every 8 hours for up to 10 days. The placebo ointment containing Vaseline with color, shape, smell and consistency similar to Olea ointment in 30 gram packages will be made and provided to the researcher by Isatis Shargh Farateb Research Scientific Company located in Yazd based on the relevant formula and will be provided to the researcher. Yes - There is a plan to make this available What will be shared: The results of the data and the main consequences will be shared after the study in format of knowledge translation and exchange report to the university, presentation of reports in domestic or foreign conferences and seminars and publication of article in domestic or foreign scientific-research journals. When: It is possible to access the study results after the defense and scientific confirmation of the dissertation In a 3 months period To whom: if requested, results will be available to other academic investigators and Vice Chancellor for Research and Technology of Guilan University of Medical Sciences Conditions: The collected data is confidential and will not be disclosed to other persons without the awareness of the Vice Chancellor for Research and Technology of the relevant university Where to obtain: To receive the documentation, send the email for update manager How to obtain: After the necessary checks, the desired documentary will be sent by email within one month period Comments:
public Parvaneh Rezasoltani
Shahid Beheshti School of Nursing and Midwifery, ِDaneshjoo St., Shahid Beheshti Blvd., Rast, Guilan, Iran
Rasht Iran (Islamic Republic of) 41469-39841 +98 13 3355 5056 rezasoltani49@gmail.com Shahid Beheshti School of Nursing and Midwifery scientific Roja Ghobadi
Al-Zahra educational, research, and remedial center, in front of Azodi stadium, Namjoo St., Rast, Guilan, Iran
Rasht Iran (Islamic Republic of) 41469-39841 +98 13 3336 9324 roja.ghobadi@gmail.com Al-Zahra educational, research, and remedial center Iran (Islamic Republic of) Willingness to participate to the study and sign a written informed consent form At least ability to read and write Gestational age 37 to 42 weeks (based on ultrasound or the first day of the last menstrual period) Primiparous Singleton pregnancy Cephalic presentation Mediolateral episiotomy Spontaneous placental delivery Birth weight between 2500 and 4000 grams The duration of the first, second and third stages of labor less than 14 hours, 2 hours, and 30 minutes, respectively no limit no limit Female Having any visible infection and lesion in the perineum History of smoking and drug use History of chronic disease during pregnancy such as diabetes, cardiovascular and coagulation diseases, and high blood pressure Prolonged rupture of membranes Having postpartum hemorrhage 090.1 Disruption of perineal obstetric wound Treatment - Drugs Treatment - Drugs Placebo Intervention group: The Olea ointment will be considered as the intervention group. In this group, the first intervention will be performed 4 hours after the episiotomy by the mother in the presence of the researcher. After washing and drying the hands and perineal area, the mother will be advised to apply a fingertip (about 2 cm or 2 g) of the ointment to the episiotomy wound in the presence of the researcher, and after about 2 minutes use a clean sanitary pad and continue every 8 hours for up to 10 days. Olea ointment containing equal proportions of honey (33.4%), olive oil (33.3%) and sesame oil (33.3%) in 30 gram packages made by Isatis Shargh Farateb Research Scientific Company located in Yazd based on the relevant formula and will be provided to the researcher. Intervention group: The Alpha ointment will be considered as the intervention group. In this group, the first intervention will be performed 4 hours after the episiotomy by the mother in the presence of the researcher. After washing and drying the hands and perineal area, the mother will be advised to apply a fingertip (about 2 cm or 2 g) of the ointment to the episiotomy wound in the presence of the researcher, and after about 2 minutes use a clean sanitary pad and continue every 8 hours for up to 10 days. Alpha ointment containing beeswax, flavonoids, unsaturated fatty acids and the active ingredient of henna and turmeric is currently made in 30 gram packages by Alpha Development Company in Iran and is available in pharmacies. This ointment will be purchased at the pharmacy. Control group: The placebo ointment (same color and shape with the Olea and Alpha ointments) will be considered as the control group. In this group, the first intervention will be performed 4 hours after the episiotomy by the mother in the presence of the researcher. After washing and drying the hands and perineal area, the mother will be advised to apply a fingertip (about 2 cm or 2 g) of the ointment to the episiotomy wound in the presence of the researcher, and after about 2 minutes use a clean sanitary pad and continue every 8 hours for up to 10 days. The placebo ointment containing Vaseline with color, shape, smell and consistency similar to Olea ointment in 30 gram packages will be made and provided to the researcher by Isatis Shargh Farateb Research Scientific Company located in Yazd based on the relevant formula and will be provided to the researcher. Episiotomy wound healing score. Timepoint: Before starting the intervention, 24 hours after the first intervention, the fifth day , and tenth day after delivery. Method of measurement: REEDA Scale (Redness, Edema, Ecchymosis, Discharge, Approximation scale). Vice Chancellor for Research and Technology of Guilan University of Medical Sciences Approved 2022-04-06 Ethics committee of Guilan University of Medical Sciences Deputy of Research and Technology of Gilan University of Medical Sciences, in front of 17 Shahrivar Hospital, Shahid Siadati Ave., Namjoo St. Rasht Guilan Iran (Islamic Republic of)