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Episiotomy Wound clinical trials

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NCT ID: NCT05358236 Completed - Pain Clinical Trials

Episiotomy Wound Care, Episiotomy Wound Healing and Pain Perception

Start date: March 3, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05282160 Completed - Clinical trials for Urinary Incontinence

The Influence of Prepartum Perineal Training With the Epi-No Device on Pelvic Floor Function.

Start date: January 15, 2018
Phase: N/A
Study type: Interventional

Perineal injury is the most common maternal obstetric complication associated with vaginal delivery (1). It is estimated that perineal lacerations of first and second degree occur in 38% of spontaneous vaginal deliveries in primiparous and in 36% in multiparous women (2). The perineal traumas are associated with significant maternal morbidity, including pain, urinary and fecal incontinence, genital prolapses, dyspareunia, physical and psychological damage (3,4). Episiotomy is a surgical procedure used in obstetrics to increase vaginal opening with an incision in the perineum at end of the second stage of vaginal delivery. However, this procedure is commonly used improperly as routine in the delivery attendance in many health services. For a successful vaginal delivery, the vaginal opening should slowly dilate in order to allow stretching because when the baby descends rapidly, the tissues can tear (11). The degree of muscle stretching or distension in the vaginal delivery may lead to pelvic floor muscle trauma (12). Urinary incontinence is the involuntary loss of urine, with impacts on women in terms of their quality of life, and is considered a social and hygiene problem (16). The muscle strength of the pelvic floor is important for the prevention, diagnosis and treatment of pelvic floor dysfunction. EPI-NO is a device that was invented by a German obstetrician in order to prepare and train the pelvic floor for normal delivery. The purpose of this study is to verify the effect of 10 sessions of pelvic floor elongation with Epi-No in the prevention of urinary incontinence and dyspareunia 6 months after delivery.

NCT ID: NCT05233527 Not yet recruiting - Episiotomy Wound Clinical Trials

Novosyn® Quick in Patients Undergoing Episiotomy Closure

RETRO-EPINOQ
Start date: May 2024
Phase:
Study type: Observational

Retrospective, monocentric clinical study on the clinical performance of Novosyn® Quick in patients undergoing episiotomy closure.

NCT ID: NCT05198908 Completed - Pain Clinical Trials

The Effect of Virtual Reality Glasse on Pain and Anxiety During Episiotomy Repair

Start date: February 15, 2022
Phase: N/A
Study type: Interventional

Episiotomy is one of the common surgical operations that can cause anxiety in women and have side effects such as pain. Nerve blockades with analgesic effects such as lidocaine used during episiotomy repair or the use of tranquilizers and sleep-inducing drugs used to reduce anxiety during this procedure may have side effects. Nowadays, the trends towards non-medical methods (virtual reality glasses, praying, distraction, music therapy) in addition to medical methods during episiotomy repair are increasing due to the inevitable nature of these methods and the absence of side effects. In the study, it is stated that women will prefer non-medical methods (such as distraction or prayer) to alleviate pain or anxiety. It is important for midwives to have knowledge about these alternative methods (music therapy, virtual reality glasses, distraction, massage, acupressure, praying) to reduce the pain and anxiety that occurs during episiotomy repair. A new technology, virtual reality (VR), helps users connect to an environment that simulates reality, reducing pain by distracting them from the real world through computers or other devices. Although initially considered a technology only for the entertainment industry, its field of application has grown over the past decade to include various clinical areas such as pain management, physical rehabilitation, and psychiatric disorders. VR is suitable for clinical use and is a non-invasive and drug-free analgesic method. Its use in obstetrics is very new. Virtual reality glasses are recognized as a safe, inexpensive and effective non-pharmacological anxiolytic agent that allows for the reduction of regular pharmacological sedative doses due to their effect on anxiety and pain perception. Skin-to-skin contact is defined by the World Health Organization as the basic component of postnatal care. Skin-to-skin contact helps to reduce the pain felt during episiotomy repair in the mother and in the postpartum period. This research was planned to determine the effect of virtual reality glasses on pain and anxiety during episiotomy repair.

NCT ID: NCT04696796 Completed - Episiotomy Wound Clinical Trials

Comparison of Episiotomy Scissors and BasIQ-4 Episiotomy Device in Mediolateral Episiotomy

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Episiotomy is an obstetric intervention performed to facilitate, accelerate and / or prevent third and fourth degree perineal tears by cutting the vagina at the end of the second stage of labor. Postpartum perineal pain affects patients' lives significantly and causes negative effects on work life, social life and family relations. Median episiotomy is associated with 3-4 times increased anal sphincter injury as well as easy recovery. Therefore, mediolateral episiotomy is preferred in Europe. The common feature was that scissors are used in previous studies and the incision was made from the central to the distal. A randomized controlled clinical study is planned to compare the scissors and episiotomy device BasIQ-4, which carries scalpel, holding apparatus, and cuts from distal to the center in mediolateral episiotomy. This is the first study in humans in this field.

NCT ID: NCT04693013 Recruiting - Anxiety Clinical Trials

Use Of Virtual Reality To Reduce Anxiety And Pain During Repair Of Perineal Laceration And Episiotomy

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Virtual Reality will be used to decrease anxiety and pain during suturing of episiotomy and perineal lacerations

NCT ID: NCT04446780 Recruiting - Depression Clinical Trials

Mediolateral Episiotomy and Obstetric Anal Sphincter Injuries in Instrumental Delivery

INSTRUMODA
Start date: April 1, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT04431102 Completed - Pregnancy Clinical Trials

Pilates and the Pelvic Floor: A Quasi-experimental Study

Start date: November 5, 2018
Phase: N/A
Study type: Interventional

In this paper, it is postulates that in pregnant women, the practice of PM led by a qualified professional for a period of four weeks can reduce the incidence of pelvic floor dysfunction (PFD) by decreasing the number of birth injuries.

NCT ID: NCT04331210 Not yet recruiting - Episiotomy Wound Clinical Trials

Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Current study aims to compare oral diclofenac sodium with it's rectal form for analgesia of pain after episiotomy.

NCT ID: NCT04288388 Completed - Labor Pain Clinical Trials

The Effect Of Ice Massage On Perceıved Pain

icemassage
Start date: April 15, 2018
Phase: N/A
Study type: Interventional

Introduction: In this study, it was aimed to examine the effect of ice massage applied to the hand during episiotomy repair on perceived pain. Methods: The study was carried out in the delivery unit of a maternity hospital between April 15, 2018 and November 15, 2018 with vaginal delivery for the first time, no complication developed during the delivery, with the study group being 178 and the control group being 169 with 347 women. Immediately before the episiotomy repair was started (after exit of placenta and applying local anesthetic agent), women assigned to the study (massage) group were asked to place plastic gloves filled with ice pieces in the LI4 point on hand. This application was made for 5 minutes to the right hand and for 5 minutes to the left hand. The episiotomy was opened by the same midwife as all the women to the right mediolateral and repaired by the same midwife with the same technique and material.The ice massage was repeated until the episiotomy repair was over; total massage time and episiotomy repair time were recorded. Women were asked to mark the perceived pain level before the application and at the end of the application using the VAS (Visual Analog Scale) (perceived pain level during episiotomy repair). In the control group women were not excluded from routine practice; women were asked to mark the perceived pain level before episiotomy repair begin and at the end the repair using the VAS (Visual Analog Scale) (perceived pain level during episiotomy repair) like the study (massage) group. Data were evaluated by using chi square, student t test and ANOVA in SPSS 18.0 program. In order to carry out this study , the necessary consent was obtained from the ethics committee, institution and women.