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Episiotomy clinical trials

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NCT ID: NCT05905263 Not yet recruiting - Virtual Reality Clinical Trials

The Effect of Virtual Reality Application on Student Satisfaction, Self-Confidence, and Anxiety Levels

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The study aims to develop a virtual reality application for episiotomy training and to determine the effect of the virtual reality application on student satisfaction, self-confidence, and anxiety levels. It was found that there should be a total of at least 102 students, 51 of whom are Virtual Reality practice groups (experimental) and 51 Dana Language practice groups (control), who meet the inclusion criteria. Considering the losses, it was decided to include 110 students in the study.We are collected usıng a Personal Informatıon form, Student Satisfaction and Self-Confidence in Learning, State and Trait Anxiety Inventory- STAI I-II

NCT ID: NCT05776849 Completed - Episiotomy Clinical Trials

Flipped Classroom in Episiotomy Education

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

This study aims to evaluate the effect of using inverted classroom design on students' knowledge, skills and anxiety levels in teaching episiotomy application and repair, one of the interventions frequently used in labour.

NCT ID: NCT05486624 Completed - Episiotomy Clinical Trials

The Effect of Reiki Application on Episiotomy and Perineal Pain

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

Purpose: To investigate the effect of Reiki application on postpartum episiotomy recovery and perineal pain in postpartum women who had vaginal delivery. Design and framework: The research is randomized controlled in a pre-test post-test order in a hospital in Turkey. By using Simple Random Numbers Table as the randomization method in the selection of the sample, a total of 86 puerperal women, 40 in the intervention group and 46 in the control group, were recruited. Episiotomy recovery of the intervention and control groups on the 1st day, 2nd day, 7th day, and 14th day postpartum was evaluated with the REEDA Scale, and perineal pain was evaluated with the McGill Pain Scale Short Form. Participants: Postpartum women who gave vaginal birth participated in the study. Intervention: 3 sessions of Reiki for 35-40 minutes were applied to the intervention group on the 1st, 2nd and 7th days of birth. Results: There was a significant difference between the mean REEDA Scale edema scores in the 7th day (p=0.028) and 14th day (p=0.013) follow-up of the intervention and control groups. A significant difference was found between the 3rd post-test McGill Pain Scale Short Form total pain score averages (p=0.005) and the 4th follow-up McGill Pain Scale Short Form total pain score averages (p=0.001) of the intervention and control groups.

NCT ID: NCT05345600 Recruiting - Pain Clinical Trials

MILTA vs Placebo Use Comparison for the Management of Pain Related to Perineal Scars Following Delivery

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

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.

NCT ID: NCT03780530 Not yet recruiting - Episiotomy Clinical Trials

Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair

Start date: January 1, 2019
Phase: Phase 3
Study type: Interventional

this study aims to assess the efficacy and the safety of various cosmetic techniques (subcuticular, surgical glue, adhesive tapes) for perineal skin closure during mediolateral episiotomy repair

NCT ID: NCT03084549 Completed - Episiotomy Clinical Trials

Study of the Analgesic Effect of the Perineal Infiltration of Ropivacaine 0.75% Versus Placebo in Post-episiotomy Perineal Pain

ROPISIO
Start date: October 24, 2017
Phase: Phase 3
Study type: Interventional

Episiotomy is a common obstetric gesture (20 to 30% of deliveries by the low route). In postpartum, perineal pains associated with episiotomy are common, about 70% on D7 and persistent 13% at 5 months. Most studies of obstetrical analgesia have focussed on pain during labor or following a caesarean section. The perineal pain associated with the realization of an episiotomy has been much less studied and often undervalued. Local ropivacaine has shown its effectiveness in the reduction of postoperative pain in many indications (wall surgery, hemorrhoidectomy, infiltration of trocar scars during laparoscopy). This product has the advantage of being well tolerated, easy access and administration. Three recent studies compared the post-episiotomy analgesic efficacy of local ropivacaine versus lidocaine versus placebo and lidocaine versus no infiltration. Two of these studies showed statistically significant results. However, they focused on the results at 24 and 48 hours and did not evaluate the analgesic efficacy in the medium and long term.

NCT ID: NCT02911779 Completed - Episiotomy Clinical Trials

The Optimal Angle of Mediolateral Episiotomy at Crowning of the Head During Labor

Start date: February 2012
Phase: N/A
Study type: Interventional

In order to determine the optimal angle to perform an episiotomy, the investigators assessed the angle of marked episiotomy lines at the first stage of labor and at the time of crowning of the head. Incision lines for mediolateral episiotomy were pre-marked on the perineal skin at 30°, 45°, and 60° angles from the midline, at the first stage of labor, in women with singleton pregnancies. The angles of the marked lines were measured again at crowning of the head. Mediolateral episiotomy was performed only for obstetric indications.

NCT ID: NCT02905695 Completed - Episiotomy Clinical Trials

Post-partum Perineal Pain - Chirocaine®

EPISIO
Start date: January 2011
Phase: Phase 4
Study type: Interventional

The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree tear. The pain intensity is measured in immediate postpartum period by using a numerical rating scale (NRS) at the following times: H2, H4, H8, H12, H24, H36, H48 during rest, defecation and during activities. The safety of Chirocaïne® and the patient satisfaction are also evaluated at each time.

NCT ID: NCT02847936 Recruiting - Episiotomy Clinical Trials

Efficacy of Triclosan-coated Sutures in the Episiotomy

EPISIOVIC
Start date: July 2016
Phase: Phase 4
Study type: Interventional

Surgical repair of perineal lesions after delivery can be associated with infection of the surgery site. The aim of this study was to compare the surgical site infection with triclosan-coated suture (Vicryl Plus) versus coated suture (Vicryl) in the episiotomy after delivery.

NCT ID: NCT02796547 Withdrawn - Episiotomy Clinical Trials

Effect of Levobupivacaine Infiltration on the Post Partum Perineal Pain in Episiotomy, in Primiparous Women After Instrumental Delivery

Start date: July 14, 2016
Phase: Phase 2
Study type: Interventional

An episiotomy is an incision of the perineum to facilitate childbirth by natural means. Perineal pain are more frequent and intense if the incision of the perineum is important. In particular, simple vaginal or perineal tears are less painful than episiotomies in the first seven days postpartum, whereas at six weeks postpartum, there is no significant difference anymore.The patients are the most symptomatic in the immediate postnatal period, but the pain may persist up to 2 weeks after delivery in 20 to 25% of cases. These pains are often undervalued and may interfere with the mother-child bond in the absence of an effective treatment. Perineal pain are usually treated with painkillers, in particular non-steroidal anti-inflammatory drugs given orally or rectally and paracetamol. The scar infiltration is one of the components of a multimodal postoperative analgesia strategy. It consists in the simultaneous use of several drugs or analgesic techniques, acting on different pain components in order to improve the overall efficiency.The most used local anesthetics at present are bupivacaine, ropivacaine and levobupivacaine.Ropivacaine has a lesser vasodilatory effect than bupivacaine, resulting in longer persistence at the injection point and a blood resorption that is more spread. The systemic toxicity threshold is also higher. Levobupivacaine is the enantiomer of bupivacaine. It has vascular effects, and an intermediate systemic toxicity threshold intermediate between bupivacaine and ropivacaine. Lidocaine has a limited duration of action. Its use is interesting in complement infiltrations when a rapid onset of action is desired. So far, there is no data in the literature regarding the effect of levobupivacaine in episiotomies associated pain. The objective of this study is to evaluate the effect of local injections of levobupivacaine on episiotomies associated pain.