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Showing 1-20 of 29 trials
NCT07487974
This study is to assess the impact of sanitary pads infused with active oxygen and negative ions on episiotomy pain, wound healing, and postpartum physical symptoms in primiparous women. Participants will be randomly allocated to either the intervention group, utilizing active oxygen and negative ion pads, or the control group, employing normal postpartum pads. The research will assess pain intensity, recovery advancement, and physical manifestations during the initial postpartum phase. The objective is to ascertain if the intervention offers supplementary advantages relative to usual care.
NCT07277478
This randomized, single-blind controlled trial examined the effects of auricular acupressure on postpartum women who underwent episiotomy. A total of 86 participants were allocated to either an intervention group, which received routine care plus transparent auricular patches containing magnetic beads applied to selected acupoints, or a control group, which received identical patches without magnetic beads. The patches were applied for 48 hours after delivery. Perineal pain and its impact on daily activities were assessed at 2, 12, 24, and 48 hours postpartum, while satisfaction with perineal pain care was measured at 48 hours. Using independent t-tests, chi-square tests, and generalized estimating equations, the study evaluated whether auricular acupressure reduced perineal wound pain, lessened pain-related interference with daily activities, and improved satisfaction with perineal pain management.
NCT05345600
The incidence of perineal scars after a pregnancy is high, either related to an episiotomy or to spontaneous perineal tears. These perineal scars can result in acute pain but also in chronic pain for some women. Medical treatment includes level 1 and 2 analgesics and, even for a few women, level 3 analgesic. The MILTA® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain : 1- The NPCL (Nano-Pulsed Cold Laser) emissions in coherent infrared light, at 905 nanometers; 2- Non-coherent emissions, pulsed by trichromatic RGB CSM diodes (400 to 650 nm); 3- Continuous non-coherent infrared emission monochromatic diodes at 905 nm; 4- A constant circular magnetic field (200 millitesla) equivalent to the terrestrial magnetic field and 5- The effect of magnetic tunnel which potentiates the light propagation. MILTA® treatment has been shown to be effective in various managements of pain, but has never been used in pain related to perineal scars. This randomized controlled trial aims at assessing MILTA vs placebo to reduce pain related to perineal scars after pregnancy.
NCT07073131
Total 202 patients fulfilling the selection criteria were enrolled from labor room and underwent episiotomy. At end of procedure, females were randomly divided in two groups. In group A, females underwent suturing by using vicryl rapide. In group B, females underwent suturing by using chromic catgut. After 24 hours of delivery, females were examined for pain score. After 7 days, females were examined for wound infection, inflammation and dehiscence. All this information was recorded in proforma.
NCT06379048
Episiotomy is the intentional incision of the perineum during vaginal birth in order to accelerate the active phase of labor. This study aimed to compare various skin closure techniques in episiotomy repair.
NCT06980220
The primary goal is to assess whether this practice reduces the incidence and severity of perineal tears. Secondary objectives include evaluating the impact of the massage on perineal pain in the postpartum period and on the episiotomy rate. Participants will include primiparous women with singleton pregnancies who delivered spontaneously via vaginal birth. Exclusion criteria include instrumental deliveries, breech presentations, and preterm births. Data will be collected through a questionnaire filled out by midwives immediately after birth, as well as additional data extracted from medical records. All data will be anonymized using a birth number code. The questionnaire collects information on whether a perineal massage was performed, the type of product used, the birth position, use of warm compresses, performance of the Ritgen maneuver, and perineal outcomes. The medical record will provide demographic and clinical data, including the mother's age, BMI, labor duration, pushing time, newborn weight, and head circumference. The study aims to provide evidence on whether perineal massage with gel at expulsion is an effective strategy to prevent severe perineal trauma and improve postpartum recovery.
NCT06955507
The act of giving birth can expose women to many risks during pregnancy and the birth process. It causes long-term emotional problems in pregnant women who experience labor pain and negatively affects their mental health. Episiotomy is a method applied to facilitate the birth of the baby by enlarging the vaginal opening. The postpartum period can significantly affect the lives of every mother, especially mothers who have had an episiotomy and vaginal birth. Many factors such as pain, fatigue and the negative effects of anesthetic drugs can negatively affect postpartum comfort and breastfeeding, causing late mother-baby bonding. With the support and information given to women during this period, women can be helped to make healthier and more accurate choices. They increasingly prefer natural methods to cope with problems that arise after birth. Some methods are used to accelerate recovery and prevent potential problems. Reflexology is an energy balancing system and special pressure method applied to reflex points with rubbing, squeezing and patting movements to increase rapid recovery.
NCT06348680
The goal of midwifery undergraduate education is; To provide students with basic professional knowledge, skills and attitudes in cognitive, affective and psychomotor dimensions. Various practices are used to provide students with midwifery skills. Case studies, maintenance processes, laboratory applications, field studies, simulation application and video monitoring are some of these applications. Each of these approaches, which are especially preferred in applied courses, has an important place in increasing students' self-efficacy and reducing their anxiety. Episiotomy is one of the obstetric interventions that negatively affects the self-efficacy of midwifery students and causes anxiety. Midwives are responsible for performing and caring for episiotomy. In many countries, episiotomy repair training is given to midwifery students using sponges or models. However, today the use of calf tongue, which is very similar to perineal tissue, has become widespread. There are a limited number of studies in the literature using calf tongue simulation. These studies suggested that the practice improved the skills of midwifery students. No study has been found in the literature using video-assisted episiotomy repair training.
NCT06711198
The correct application and repair of episiotomy, which is a frequently used intervention in labor, is important for the psychological and physiological health of the mother after birth. Therefore, it is very important to provide students with the skill of performing episiotomy with the most effective education methods, to reduce their anxiety in this regard and to increase their self-efficacy. Trying to teach suture techniques on sponge, chicken, calf tongue or a soft material is quite limited when the integrity of episiotomy education is considered. Developments in simulation techniques, especially virtual reality glasses that help users experience sensory information such as visual, auditory and movement with real-like experiences, reveal the importance of using technology in health education. Since it does not require additional materials such as calf tongue, sponge, needle holder, etc., it is important for midwifery education to be economical. In addition, the fact that the application can be repeated many times without harming the person affects the anxiety and self-efficacy levels of students before real clinical experience. Within the scope of the study, in order to evaluate the effect of using virtual reality in teaching episiotomy application and repair on students' episiotomy self-efficacy and anxiety levels, midwifery students taking the Normal Birth and Postpartum period course will be divided into three groups during the episiotomy teaching application; one group will practice on calf tongue, one group will practice only with virtual reality, and one group will practice using both. The study data will be collected through the Student Identification Form, State Anxiety Inventory, and Episiotomy Self-Efficacy Scale. The analysis of the data obtained from the research will be done with the SPSS program. It is thought that the study will make a significant contribution to the literature in terms of evaluating the effect of virtual reality glasses on episiotomy teaching.
NCT06325176
The study will be a randomized clinical trial and will be conducted in Bahawalpur Victoria Hospital, Bahawalpur. The subjects (n=24) will be divided into two groups. Group A will include 12 postnatal women and for treatment, cryotherapy will be applied for 20 minutes. Group B will include 12 women and receive infrared light, an infrared lamp will be put at a distance of 45 cm from the perineum, and the heat produced with 230 volts for twenty minutes. The participant will be checked after the first five minutes to make sure that she is not being burned. This procedure will be done twice a day for 7 consecutive days.
NCT06568289
In this study, we will compare the effect and safety of lignocaine versus bupivacaine infiltration for postpartum perineal pain after vaginal delivery with episiotomy in primigravidae.
NCT06415877
It was planned as a randomized controlled study to determine the effect of the modified simulation model on self-efficacy, anxiety and academic motivation in episiotomy training. It will be held online with students from the midwifery department of Osmaniye Korkut Ata University.
NCT05888194
The aim of this post-market clinical follow up study is to confirm the efficacy and safety of topical application of Mucogyne® gel in the process of wound healing, when used in accordance with its approved labeling, in the context of postpartum perineal wounds.
NCT04693013
Virtual Reality will be used to decrease anxiety and pain during suturing of episiotomy and perineal lacerations
NCT05955716
The aim of this clinical study is to compare the pain and fear scores of women who gave birth for the first time and who did and did not do relaxation exercises with virtual reality glasses during episiotomy incision and episiotomy repair. This research seeks answers to the following questions: Question 1: Does doing relaxation exercise with virtual reality glasses reduce the pain score experienced during episiotomy incision? Question 2: Does relaxation exercise with virtual reality glasses reduce the pain score experienced during episiotomy repair? Question 3: Does doing relaxation exercise with virtual reality glasses reduce the fear score experienced during episiotomy incision? Question 4: Does doing relaxation exercise with virtual reality glasses reduce the fear score experienced during episiotomy repair? A group of participants will be given a relaxation exercise with virtual reality glasses during the episiotomy incision and episiotomy repair. Women in the comparison group will not undergo any intervention during episiotomy incision and repair.
NCT05358236
The World Health Organization (WHO) and professional societies recommend restricted episiotomy instead of routine episiotomy. However, since the 1990s, there has been evidence of the risks of the procedure, and although routine use has no benefit, it is still widely used. In this study, investigators aimed to determine the effect of episiotomy on the wound healing process and pain perception by providing episiotomy wound healing and genital hygiene training with training material created to raise awareness about wound care after episiotomy and to eliminate factors that delay the healing of episiotomy wound.
NCT05578989
The research was conducted as a randomized controlled clinical study to determine the effect of virtual reality glasses on pain and patient satisfaction during the episiotomy repair procedure. The sample consisted of 50 pregnant woman of whom 25 were in the control group and 25 were determined by randomization among primiparous pregnant woman who met the reasearch's criteria and agreed to participate in the study.
NCT05418114
Trauma to perineal area is one of common problems faced by obstetricians affecting physical, social and mental wellbeing of patients. During labor, surgical incision to perineum (episiotomy) is done to facilitate delivery of fetus. Episiotomy is associated with complication such as hemorrhage, infection, pain and wound breakdown. Pain relief after episiotomy is primary concern of obstetrician and right of patient. Pain after delivery causes delayed mobility of patient, late initiation of breast feeding and may affect mother psychologically. Magnesium sulphate is readily available in obstetric units due to its diverse uses, wide safety margins and cost-effectiveness. Magnesium is a calcium channel blocker and noncompetitive N methyl D aspartate (NMDA) receptor antagonist with anti-nociceptive effects. Blocking of NMDA receptors inhibits central sensitization due to peripheral nociceptive stimulation. The role of magnesium has been evaluated as adjuvant for intra- and post-operative pain relief in orthopedic, gynecological, and thoracic surgeries and has established role in anesthesia and obstetrics. Lignocaine given locally does not provide adequate pain relief. There is need to find adjuvants to local anesthesia for pain relief after episiotomy. There is paucity of published data on the use of Magnesium sulphate as an adjunct to local anesthetics for episiotomy or its repair. No local study has been done in this regard.
NCT03559816
Vaginal delivery is commonly accompanied by trauma of the genital tract. Perineal trauma is classified into four degrees based on anatomic structures involved and severity of lacerations according to the American College of Obstetricians and Gynaecologists (ACOG) and the Royal College of Obstetricians and Gynaecologists (RCOG). Episiotomy is an intentional perineal incision performed by midwifes or obstetricians to enlarge vaginal opening during the second stage of childbirth and has become the most common surgical procedure worldwide. A routine use of episiotomy was proposed to prevent severe spontaneous lacerations, although it failed to to demonstrate a clear protective role with no benefits both for mother and baby. Therefore the guidelines changed in a selective use of episiotomy, and we have introduced it in our routine obstetrics care. Nevertheless, second-degree lacerations comprise a wide range of lesions, from a minimal involvement to a massive damage of the perineal muscles. Therefore, it was never confirmed that selective use of episiotomy reduce the perianal trauma in the range of second degree lesions. We designed a prospective observational study with the introduction of a new classification of perineal trauma recorded with the usual data retrieved in delivery ward register. The aim is to definitively investigate if selective use of episiotomy reduce the overall perineal trauma.
NCT04446780
Literature is contradictory about the impact of mediolateral episiotomy during operative vaginal delivery in obstetric anal sphincter injuries prevention explaining the absence of international guidelines. The investigators consider that a randomized trials does not appears feasible for both ethical and practical reason and so we suggest a large national observational study. The investigators will include all nulliparous women that underwent an operative vaginal delivery within the 72h following the delivery at more than 34 weeks of amenorrhea. The investigators will collect data about the history of pregnancy, the course of labor, the mode of delivery, maternal immediate and one-year morbidity, neonatal immediate morbidity. The investigators expect a one-year study in 129 recruiting center with 15000 included women. The primary objective is to assess the protective effect of mediolateral episiotomy against obstetric anal sphincter injury during instrumental delivery in nulliparous women according to the type of instrument used. The secondary endpoints are to investigate the effect of mediolateral episiotomy on one-year maternal morbidity, immediate maternal morbidity. The investigators also aim to develop a clinical score to assess the absolute risk of obstetric anal sphincter injury during instrumental delivery. Finally, the investigators will investigate the impact of fetal presentation ultrasound assessment immediately before instrumental delivery on the mode of delivery.