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IRCT20160427027633N9 IRCT 2023-08-05 Kermanshah University of Medical Sciences Investigating the effect of quince seed mucilage on perineal pain and healing following episiotomy Investigating the effect of quince seed mucilage on perineal pain and healing following episiotomy: a randomized, double-blind, placebo-controlled study 2023-08-23 anticipated 90 Complete https://irct.ir/trial/71540 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The mothers will be randomly assigned in to 2groups in order to Block random allocation method with block size of 4, and ratio of 1:1. It works by randomizing participants within blocks such that an equal number are assigned to each treatment. This will be done with Epi Info™6.0 software, Blinding description: The quince seed mucilage and placebo are coded in the same shape and size in two tubes so that only the pharmacist will be aware of the tube content. The researcher, clinical evaluator and statisticians will not be aware of this coding. N/A episiotomy. Intervention 1: Intervention group: quince seed mucilage . After mucilage preparation by the pharmacist, researcher and research assistant attends Motazedi Hospital maternity ward. Inclusion criteria will be entered into the study after obtaining written consent. Primiparous women undergoing mediolateral episiotomy will be selected and randomly divided in to two groups: placebo and mucilage and will be coded. Perinatal hygiene training will then be given to all two groups and they will be asked to apply the drug three times daily after rinsing with water and continue for up to 14 days. During this time, the researcher calls to participants by telephone and will be excluded if the drug is not used properly or if complications occur. Then the perineum healing and pain will be examined in the first, seventh, and fourteenth days of peurperium at Razi Hospital in Ahvaz. The VAS and REEDA criteria will be evaluated. Intervention 2: Control group: Placebo. The action is according to the intervention group. The gel formulation used in the placebo group (placebo gel) has all the characteristics of the medicinal gel of quince seed mucilage in terms of the components of the formulation (minus the active ingredient of quince seed mucilage). It contains different proportions of carbomer 934P, ethylene glycol and ethanol. After the preparation of the placebo by the pharmacist, the researcher and the research assistant attended the maternity ward of Motazadi Hospital and asked the eligible women to apply it three times a day after washing the perineum with lukewarm water and continue this for 14 days. 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 There is no further information. We will decide after the end of the study.
public Foruzan Sharifipour
Isar Square, Daulat Abad Blvd
Kermanshah Iran (Islamic Republic of) 6719816593 009838162538 sharifipour_fr91@yahoo.com Kermanshah University of Medical Sciences scientific Foruzan Sharifipour
Isar Square, Daulat Abad Blvd
Kermanshah Iran (Islamic Republic of) 6719816593 +98 83 3816 2538 sahrifipour@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) First pregnancy Vertex presentation Single and term pregnancy The normal body mass index of the mother is between 19.5 and 24.9 Uncomplicated delivery Mediolateral episiotomy Willingness to cooperate no limit no limit Female Dystocia Use of instrumental delivery Third and fourth degree perineal tears Any disease in mother and newborn Withdrawal of participants during the study Sever postpartum hemorrhage Any lesion or skin infection in the perineum Occurrence of any side effects during the intervention Use of other herbal or medical creams to heal the episiotomy during the intervention O90.1 Disruption of perineal obstetric wound Treatment - Drugs Placebo Intervention group: quince seed mucilage . After mucilage preparation by the pharmacist, researcher and research assistant attends Motazedi Hospital maternity ward. Inclusion criteria will be entered into the study after obtaining written consent. Primiparous women undergoing mediolateral episiotomy will be selected and randomly divided in to two groups: placebo and mucilage and will be coded. Perinatal hygiene training will then be given to all two groups and they will be asked to apply the drug three times daily after rinsing with water and continue for up to 14 days. During this time, the researcher calls to participants by telephone and will be excluded if the drug is not used properly or if complications occur. Then the perineum healing and pain will be examined in the first, seventh, and fourteenth days of peurperium at Razi Hospital in Ahvaz. The VAS and REEDA criteria will be evaluated. Control group: Placebo. The action is according to the intervention group. The gel formulation used in the placebo group (placebo gel) has all the characteristics of the medicinal gel of quince seed mucilage in terms of the components of the formulation (minus the active ingredient of quince seed mucilage). It contains different proportions of carbomer 934P, ethylene glycol and ethanol. After the preparation of the placebo by the pharmacist, the researcher and the research assistant attended the maternity ward of Motazadi Hospital and asked the eligible women to apply it three times a day after washing the perineum with lukewarm water and continue this for 14 days. Perineal pain. Timepoint: 1, 7 and 14 days after delivery. Method of measurement: VAS pain visual analog scale. Episiotomy site healing. Timepoint: 1, 7 and 14 days after delivery. Method of measurement: Rida scale. Kermanshah University of Medical Sciences Approved 2023-07-04 Ethics committee of Kermanshah University of Medical Sciences Shahid Beheshti Blvd., Central Building of Kermanshah University of Medical Sciences Kermanshah Kermanshah Iran (Islamic Republic of)