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NCT06945250
The informed consent process is an important part of any surgical and anesthetic intervention. It is also perhaps the most intellectually demanding portion of interacting with the healthcare system for patients. Competent patients have full autonomy over which treatments they receive, and making an informed choice about the decision to undergo a treatment requires at minimum a discussion of the proposed intervention, its risks and benefits, and alternatives to the proposed intervention. The objective is to improve the anesthesia informed consent process for patients undergoing elective Caesarean delivery through the use of a pre-recorded audiovisual presentation that discusses the logistical aspects of perioperative care and the risks and benefits of anesthesia which is provided to patients prior to meeting their anesthesiologist. The hypothesis is that the use of an audiovisual presentation which explains the purpose and nature of anesthesia for Caesarean delivery provided to the patient at least 24 hours prior to their procedure will result in a 10% increase in the effectiveness of risk communication and treatment decision making as measured by the Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE) tool.
NCT07384455
This study was designed as a prospective randomised study. In this study, the researchers planned to evaluate the effect of intravenous vasopressor agents administered to patients undergoing caesarean section under spinal anaesthesia on the incidence of hypotension. Our other aim was to evaluate perioperative haemodynamic data, maternal side effects and neonatal outcomes.
NCT07322601
Introduction: Severe acute pain after cesarean section is an independent risk factor for the development of chronic pain and increases the risk of postpartum depression threefold. Pain also reduces the mother's ability to breastfeed and care for her child. This study aimed to evaluate the supportive effectiveness of auricular acupressure in reducing incision pain and uterine contraction pain in women undergoing cesarean section, compared with sham auricular acupressure. Methods: A randomized, controlled, single-blind clinical trial was conducted in seventy women undergoing cesarean section, randomly allocated (1:1) to an auricular acupressure or sham group. The study group received vaccaria seeds, and the sham group received non-vaccaria patches on both ears. Both groups were treated at the Shenmen, Lung, Internal Genitalia, Pelvis, Subcortex, and Sympathetic points. Pain was assessed using the Visual Analog Scale (VAS), and diclofenac consumption was recorded over the first 48 hours postpartum.
NCT06797973
The goal of this clinical trial is to learn if morphine added to the spinal anaesthesia can improve postoperative pain treatment for patients undergoing caesarean section, without increasing the risk of serious adverse events in mother and baby. The main questions it aims to answer are: * Is the treatment effective in preventing postoperative pain? * Is the treatment safe for both mother and baby? Participants will be given a normal spinal anaesthesia with addition of either morphine or sodium chloride (inactive substance). All participants will receive standard postoperative pain treatment, including morphine tablets as needed. Researchers will collect data from the electronic medical record and ask the participants to fill out questionnaires about pain levels and possible side effects.
NCT07247643
Due to the stressful nature of cesarean birth, it is important that the use of virtual reality (VR) glasses is both feasible and effective. While wearing VR glasses, the distraction effect can reduce women's focus on pain and the surgical procedure itself. Furthermore, VR applications have been shown to increase women's satisfaction with the birth experience. This study will be conducted as a randomized controlled trial. A total of 96 participants will be included, with 48 assigned to the intervention group and 48 to the control group. The intervention group will consist of women undergoing repeat cesarean section under spinal anesthesia. During the procedure, participants in the intervention group will watch nature videos with sound through VR glasses. The VR application will be paused when the baby is born to allow for initial neonatal care and skin-to-skin contact. After skin-to-skin contact has been established, the VR application will resume and continue until the completion of the suturing process. Subsequently, once the women are transferred to the ward, the "Personal Information Form," the "Postpartum Comfort Scale," and the "Cesarean Birth Satisfaction Scale for Women Under Spinal Anesthesia," developed by the researcher, will be administered at an appropriate time. This study is expected to support healthcare professionals in integrating VR technology into childbirth practices by providing insights into women's experiences with this intervention. In this way, the study aims to reduce negative emotions experienced during cesarean birth, support the postpartum recovery process, and enhance overall patient satisfaction. Moreover, the findings will contribute to improving the feasibility of digital innovations in healthcare, enhancing the quality of birth experiences, and strengthening the approach to patient-centered care.
NCT07175363
This study explored the association between postoperative functional recovery and the formula of analgesic pumps as well as other related factors (such as age, intraoperative blood loss, operation duration, etc.) by retrospectively analyzing the clinical data of patients undergoing cesarean section in the main campus and branches of Sichuan Provincial People's Hospital from September 2024 to June 2025. The value of this study lies in: 1) providing a basis for optimizing the postoperative analgesia plan after cesarean section. 2) To provide references for the formulation of personalized analgesia strategies in clinical practice, improve the postoperative recovery quality of patients, promote the concept of enhanced recovery after surgery, and reduce the medical burden.
NCT07134179
In Denmark, approximately 20% of all children are born via cesarean section (C-section), making it the most common surgical procedure (also internationally). The recommended anesthesia for cesarean sections is regional anesthesia (spinal or epidural, "spinal anesthesia"), as it has several advantages: the woman is awake and experiences the delivery of her child, she maintains spontaneous breathing. Furthermore, regional anesthesia can contribute to early postoperative pain management to some extent. With spinal anesthesia, most women feel pressure and touch but no pain during the cesarean section. However, some women do experience pain during the procedure, necessitating further intervention or ultimately a change in anesthetic form. If inadequate anesthesia is detected before the surgery begins, one may choose to administer renewed regional anesthesia (typically an epidural). However, if the woman first experiences pain after the surgery has commenced, it can be necessary to place her under general anesthesia for the remainder of the procedure. Experience shows that this process can be challenging, and there are frequent examples in clinical practice of inappropriate courses of action, where women have experienced unacceptable pain during their cesarean sections without being placed under general anesthesia. The consequences of inadequate anesthesia for cesarean sections can be quite significant for women, including impaired bonding with the child, poorer establishment of breastfeeding, increased risk of postpartum reactions and post-traumatic stress. The aim of this study is to investigate how women experience insufficient regional anesthesia during cesarean sections, in cases where the regional anesthesia was not converted to general anesthesia. The focus is on exploring the factors that contribute positively and negatively to the woman's experience in this situation, and investigate if any recommendations for how to handle the situation can be extrapolated from the women's experiences. Method Qualitative study. Inclusion criteria: * Adult women undergoing elective or emergency cesarean delivery within the last 2 years, with the experience of pain during surgery * Regional (spinal or epidural or combined epidural-spinal) anesthesia NOT converted to general anesthesia Exclusion criteria: * Does not speak Danish or English * Does not wish to participate Relevant women will be invited to contact us through public post on social media. If a woman responds to the post, she will be offered further information about the project, both verbally via telephone and in writing sent by email. Women can also be invited to participate if encountered by a project-group member during clinical work. Participants will be invited to an interview via telephone. This will take place as a semi-structured interview, initiated with open questions and concluded with a few more specific questions. At the end of the interview, a screening for post-traumatic stress will be conducted using the PTSD-8 tool. Interviews will be recorded digitally and transcribed verbatim. The interview guide will be developed with input from the entire project group and with participation from three mothers who have previously experienced insufficient regional anesthesia during a cesarean section. The guide will be pilot-tested on 2-3 patients after cesarean section. The interview guide may be adjusted during the study, if necessary. The number of women required to participate before a sufficient amount of information is obtained (as no new information is expected from subsequent interviews) is not known in advance; however, it is estimated that 20 women will need to participate. However, the sample size is also defined by convenience, as the investigators do not know how many women it will be possible to establish contact with via the Facebook post and through clinical work. If too few women (e.g. \<15) are included within the first two months, the investigators will make a new public posting and expand the period of inclusion to concern cesarean sections within the last 5 years instead of 2 years. Baseline data regarding the mother and the cesarean section will be collected by asking the women during the scheduled interview, and therefore access to medical records are not necessary. Qualitative data will also be gathered through the interview, conducted as a semi-structured interview based on an interview guide. Data will be entered into SurveyXact software, where it will be securely stored. Data will be handled using descriptive statistics. Interview data will be analyzed using content analysis. Nvivo software will be used for managing and coding qualitative data.
NCT06668428
This study was conducted to determine the effects of virtual reality application on pain and anxiety in women who gave birth by caesarean section. It was applied to women who had given birth by caesarean section at a public hospital in northern Turkey, voluntarily agreed to participate in the study, and were randomly assigned to the intervention (n=40) and control (n=40) groups. Women in the intervention group were taught how to use virtual reality goggles. After the first mobilisation, women were shown a nature landscape video through virtual reality goggles (VRG) accompanied by nature sounds for an average of 20 minutes. The aim of this application was to enable women to view nature images more effectively accompanied by nature sounds, thereby helping them to focus on the images and sounds, distract their attention, relax, and escape the tension of their surroundings. The application was carried out with the women in a semi-reclining position and without sleeping. The same application was applied to each woman, and the glasses were disinfected with Dermosept surface disinfectant, which provides cold sterilisation, before the application. No application was made to the women in the control group; only the hospital's routine care was applied. The data were collected by the researcher through face-to-face interviews based on the statements of women after caesarean section.
NCT06646835
This study will be conducted to determine the effect of stress ball application on anxiety and fetal heart rate in risk pregnant women before cesarean section. Women with risk pregnancies randomly assigned to intervention (n=44) and control (n=44) groups in a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be instructed how to use the stress ball in the obstetrics ward before cesarean section. During the practice, pregnant women will be asked to demonstrate the movements of tightening and loosening the stress ball to ensure correct use. It will be emphasized to the pregnant women that they should squeeze the ball once after counting to three, inhale when they squeeze the ball, exhale when they loosen their grip and focus only on the ball. Pregnant women in the control group will not receive any intervention other than routine general care. Data will be collected face-to-face by the researcher based on the self-reports of the pregnant women before cesarean section.
NCT07091760
Objective: To determine the effect of Su Jok application on pain, anxiety and comfort level after cesarean section. The research will be conducted as a randomized controlled experimental study with pretest-posttest control group
NCT07074522
This study aimed to evaluate uterine scar thickness and integrity using transvaginal ultrasonography in women randomly assigned to single versus double-layer closure of the uterine incision, with a comparison between the two groups.
NCT06946914
The aim of our study is to evaluate the efficacy of Misoprostol before elective cesarean section in pregnant women with gestational age less than 38 weeks for preventing the occurrence of neonatal respiratory morbidity.
NCT05009771
Caesarean section is one of the most frequent surgeries causing severe postoperative pain. Poor management of acute pain can contribute to postoperative complications, late recovery and the development of chronic pain. Moreover, it had been demonstrated that the intensity of postpartum pain is associated with depression. It is imperative to find out appropriate methods of postpartum pain alleviation. Currently, a lot of analgesic drugs and methods have been developed and used in clinical practice, such as patient-controlled analgesia, extended-release analgesics and multimodal analgesia. This prospective cohort study is aimed to investigate the outcome of each postoperative analgesic method used in caesarean section.
NCT06939725
Postoperative analgesia treatment methods are applied to the living in the operating room. It is a routine part of the process of these applications. It is necessary from medical and ethical perspectives. Postoperative analgesia applications are started in the preoperative period and continue in the postoperative period. The analgesic treatment to be used is shaped according to the application and experience of the anesthesiologist. The scientifically accepted developed method is multimodal analgesia protocols. These protocols cover a wide range from paracetamol to opioids, peripheral and central blocks (such as Transversalis Fascial Plane Block (TFPB) and Transversus Abdominis Plane (TAP) Block). The aim of this study is to continue the analgesia protocols applied in cesarean section surgeries on the first 24-hour pain scores, the amount of opioid consumed after surgery and the quality of obstetric recovery (ObsQoR-10) scale.
NCT06803979
Labor itself can occur spontaneously vaginally, with the help of extraction methods, or via cesarean section. It can also be planned or awaited for the spontaneous onset of uterine contractions. Each method has its advantages and disadvantages regarding potential damage to the pelvic floor and its stability in vaginal delivery or extraction methods, or concerning the stability of the abdominal wall with subsequent wound healing after a cesarean section. The aim of the study is to retrospectively and prospectively determine the impact of the method of delivery on the performance of female athletes through a questionnaire study. Investigators would like to answer the question of whether cesarean delivery means a later return to training for athletes, whether pregnancy is problematic for female athletes in relation to their BMI, and whether pregnancy often signifies the end of a sports career for female athletes. The questionnaire also includes questions regarding overall women's health-menstrual cycle, incontinence, and mental health of female athletes. Prospectively, the questionnaire will be sent to all female athletes who meet representation limits once a year and for two years after retiring from the national team.
NCT06827600
Purpose: It will be carried out to determine the effect of breastfeeding education given to nulliparous pregnant women before cesarean section on breastfeeding intention and breastfeeding attitudes in the postpartum period. Material method: The research, planned as a randomized controlled experimental study, will be carried out with a total of 70 mothers who are hospitalized in the Maternity Clinic of Bursa Uludağ University Research and Practice Hospital and who meet the study assignment criteria and who are determined by simple randomization method. Breastfeeding education and support will be provided to 35 women in the experimental group, and 35 women in the control group will be left to the hospital's usual care. Data will be collected between April 2024 and January 2025 using the "Introductory Form," "Newborn Feeding Intention Scale," and "Breastfeeding Attitude Evaluation Scale." The educational intervention will be carried out one-on-one in the woman's own room during the prenatal period for the women allocated to the experimental group. In addition to the explanation, question and answer, and visual material use, the demonstration technique with a newborn model will be used in the education. A booklet containing written illustrated breastfeeding education prepared in line with the literature will be given to mothers with cesarean delivery. The data will be filled in the "Introductory Information Form," "Newborn Feeding Intention Scale," and "Breastfeeding Attitude Assessment Scale." The data of the study will be analyzed in the Statistical Package for the Social Sciences (SPSS) for Windows 20.0 package program. Descriptive statistics (arithmetic mean, minimum-maximum, standard deviation, number, and percentage), Student t-test, one-way analysis of variance (ANOVA), Mann-Whitney U test, and Kruskal-Wallis test will be used in the analysis of the data. Expected Result: Determining the effect of breastfeeding education given to nulliparous pregnant women before cesarean section on breastfeeding intention and breastfeeding attitudes in the postpartum period will guide health professionals. It will be a resource for studies that can be conducted on different sample groups and in different regions on the subject and will contribute to national and international literature and scientific knowledge with the publication to be made.
NCT06824337
This study was planned to evaluate the effect of early mobilization training given to patients undergoing cesarean section in the preoperative period and targeted mobilization program applied after the surgery, on preventing gastrointestinal complications that may develop after the surgical intervention and participating in breastfeeding and baby care. The research will be conducted in experimental design. The research will begin after receiving written permission from Niğde Ömer Halisdemir University Ethics Committee, Niğde Provincial Health Directorate and Ömer Halisdemir Training and Research Hospital. Pregnant women who are between the ages of 18-35, who are at least a primary school graduate, who gave birth at term, who have a live singleton pregnancy, and who do not have a risky pregnancy history (DVT, thromboembolism) will be included in the study. Before starting the research, the study will begin by obtaining institutional permissions and written permission from the pregnant women. Personal Information Form prepared in line with the literature, postoperative gastrointestinal functions information form, postoperative abdominal distension diagnosis form, walking chart, VAS, LATCH Breastfeeding Diagnosis and Evaluation Scale and Breastfeeding Information Form data collection forms will be used to collect data. The data will be evaluated on a computer using the IBM SPSS Statistics 24 (Statistical Package for the Social Sciences for Windows) package program. Appropriate statistical analyzes will be used to evaluate the data
NCT04548973
This study proposed applying intravenous Esketamine to cesarean section in parturient, detecting the plasma concentration of Esketamine in maternal blood, neonatal umbilical venous blood and umbilical arterial blood when the baby is delivered ketamine blood drug concentration, observing vital signs, adverse visual analog pain score (VAS), and sedation score (Ramsay) in parturient, neonatal Apgar score 1, 5 to 10 minutes after birth, the umbilical arterial blood gas and neurobehavioral scores (NBNA) 2, 24 hours after the birth. This study aims to address placental transfer, metabolism and analgesic and sedative effects in neonates and parturients of Esketamine so as to explore the feasibility, efficacy and safety of Esketamine as adjuvant medication for cesarean section.
NCT06602505
The study aimed to evaluate the effectiveness of field block in preventing postoperative low back pain (PDPB) in patients undergoing Cesarean Sections.
NCT04435496
GYN-CS® is a new concept in intrauterine device technology. It is fixed to the uterine fundus, is frameless and entirely flexible. The GYN-CS® 3 has a lifespan of 3 years and GYN-CS® 10 has lifespan of 10 years, both used in this study. The primary objectives are: Analyse the learning curve of the surgeon and the ease of insertion of the device.