At a glance
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The Effect of Designed Protocol of Care on the Outcomes of Postpartum Perineal Trauma: a Randomized Controlled Trial (RCT)
In Brief
A clinical study evaluating 1-perineal ice-gel pad application, 2-performance of pelvic floor exercises (Kegel exercises), and 1 other intervention for Perineal Injury. Completed, enrolled 100 participants across 1 site.
Detailed Summary
the study is intended to test the effect of designed protocol of care that include perineal ice-gel pad application, performance of pelvic floor exercises (Kegel exercises) and perineal warm compresses application on the outcomes of postpartum perineal trauma among women with vaginal delivery at postpartum ward.To fulfill the aim of this study the following research hypothesis is formulated: H1: Post partum women with perineal trauma who will receive the designed protocol of care will have better perineal trauma outcomes than those who will receive the routine hospital care.Sub-hypothesis 1: Postpartum women with perineal trauma who will receive the designed protocol of care will show better perineal trauma healing than those who will receive the routine hospital care. Sub-hypothesis 2: Postpartum women with perineal trauma who will receive the designed protocol of care will have less perineal pain score than those who will receive the routine hospital care.
Study Details
Timeline
Interventions
For the study group Immediately after delivery (within 30 minutes to one hour after delivery), an ice gel pad will be applied to perineal trauma. each gel pad will have fixed standardized diameter (an approximately 5 cm width, 23 cm length, and 1.5 cm thickness) and approved by Egyptian ministry of health. It will be kept in the freezer for 45-60 minutes and will be removed when frozen. Then, it will be wrapped in a sterile pad and applied to cover the perineum and anal region.The investigator will provide a clear and concise information through oral and written instructions about the following; 1) The ice gel pad's purpose, benefits, anticipated effects and how to apply it, 2) Apply the ice gel pad on perineum after birth within 30 minutes to an hour, 3) Instruct the women to apply the ice gel pad for about 20 minutes every two hours during the first 24 hours postpartum only
women will receive instructions to practice pelvic floor exercises (Kegel exercises) and will be asked to perform these exercises from 6 hours postpartum and continue at home till one week. Before applying the technique, the investigator will teach the women how to recognize the accurate muscle, whereby she imagines holding passing gases or trying to stop the flow of urine midstream at the same time. The women will be taught to insert a clean finger into the vagina before practicing the exercises and if the women feeling pressure around her finger, she is on the right track, . The investigator will perform vaginal examination while the woman is doing the pelvic floor exercises (Kegel exercises) to ensure correct use of muscles. The investigator will instruct the women to continue contracting the muscles for about 5 seconds and then to loosen them for 5 seconds and repeat it for five times each set, perform at least five sets per day
women will be instructed to apply warm compresses on perineal trauma 48 hours postpartum at home. This will be done by using a clean pad soaked in warm water and squeezed to remove excess water then placed gently on the perineum, the warm compresses will be applied for 15 minutes three times per day (every 8 hours), and water in the bowl will be replaced with every application. Women will be asked to apply warm compresses on perineal trauma from 48 hours postpartum till one week.