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Labor Pain clinical trials

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NCT ID: NCT05217134 Completed - Analgesia Clinical Trials

Sacral Spread of Sensory Block After Dural Puncture Epidural Technique Compared With Epidural for Labour Analgesia

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

Neuraxial labor analgesia is a very widely used technique for labor pain relief with a high efficacy and safety. EA (Epidural analgesia) can guarantee a proper control of pain in 95-100% of cases in the first stage of labor, but in the second stage his efficacy is not always adequate. DPEA (Dural Puncture Epidural Analgesia) is a variation of the conventional EA and technically a modified version of the CSE (Combined Spinal Epidural) analgesia. When compared with the traditional EA, DPEA showed satisfying, effective and fast control of labor pain, no motor block and less need for anesthetic boluses given through the epidural catheter when the maintenance of analgesia was guaranteed with manual top-ups, as well as less request for extra boluses of anesthetic when PIEB (Programmed Intermittent Epidural Boluses) was chosen for the maintenance of analgesia. Studies proved that DPEA is a safe technique and no statistically significant incidence of side effects for mothers and fetuses was observed. The hypothesis of this study is that a DPEA performed with a 27 G Whitacre spinal needle can especially improve the spread in the sacral region. The primary outcome of this study is to evaluate whether the DPEA performed with a 27-G Whitacre spinal needle is more effective in ensuring satisfying analgesia as a result of a better sacral analgesic spread, compared to the traditional EA.

NCT ID: NCT05196841 Completed - Labor Pain Clinical Trials

The Effect of Fatima Ana's Hand on Birth Pain and Duration

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

Research Question: Does the Anastatica Hierochuntica have an effect on labor pain and duration? Methods: This study was planned as a a double blind randomized controlled experimental study. The study was conducted with 60 pregnant women who were randomized between February 2019 and November 2020 at a university and private hospital located in Anatolia, Turkey.

NCT ID: NCT05196256 Not yet recruiting - Analgesia Clinical Trials

Study Comparing Dural Puncture Epidural With Epidural and Combined Spinal Epidural Anesthesia for Obstetric Analgesia.

Start date: June 30, 2022
Phase: Phase 3
Study type: Interventional

This will be a prospective, randomized, double blind, controlled clinical trial. Epidural analgesia (EP) is currently the method of choice to ensure the comfort of the parturient during childbirth. Technical and pharmacological advances in recent years have made it possible to provide patients with high quality analgesia with individualized control, associated with extremely limited motor block. However, sometimes this technique fails due to a prolonged delay in action, or insufficient sensory block. An alternative technique has become popular in recent years, the combined peri-spinal anesthesia also called sequential (CSE). It combines the administration of low doses of local anesthetics and/or intrathecal opiates before the placement of the catheter in the epidural space and the use of the catheter as in a classical technique. This technique would allow a more rapid onset of analgesia, a more complete relief of the patient, and a lower degree of failure. However, it could be accompanied by a greater risk of maternal hemodynamic instability, fetal bradycardia, and a longer expulsion period. In addition, the effectiveness of the catheter injection can only be assessed when the effects of the spinal injected drugs have worn off. In order to limit these undesirable effects, it has been proposed to perform a dural puncture as performed in the sequential technique but without intrathecal drug injection (DPE). In this way, a "tunnel" is created, allowing the diffusion of drugs from the epidural space to the subarachnoid space. Thus, the initiation of anesthesia would be faster with a lower risk of lateralization compared to the standard epidural, also allowing a decrease in the consumption of local anesthetics and without the undesirable effects of the sequential. Although this technique recently introduced in obstetrical analgesia appears promising, very few studies to date have evaluated its effectiveness and safety. The hypothesis of the study is that the Epidural with Dural puncture (DPE) provides a higher quality of analgesia than standard epidural while having fewer adverse effects than combined epidural, in particular a lower incidence of maternal hypotension. The primary objectives are: - testing the quality of analgesia with DPE compared to PE and CSE. This will be assessed by determining the area under the curve of Visual Analog Scale (VAS) measurements observed from the beginning of obstetric analgesia and throughout the delivery. - testing the rate of maternal hypotension with DPE compared with PE and CSE, with hypotension defined as a decrease in systolic blood pressure (SBP) greater than 15% from the SBP measured at the time of the parturient arrival in the labor room, a SBP < 90 mmHg, or any decrease in pressure associated with disabling symptomatology (dizziness, yawning, nausea). For this purpose, the investigators will randomize a total of 90 patients, 30 in each of the groups. The patients will receive one of the three techniques, all of them will benefit from the administration of epidural analgesia with low concentration local anesthetics and opioids on a Intermittent bolus modus (PIB). Patients assigned to the combined spinal epidural modus will receive a injection of a small quantity of local anesthetics and opioids (Levobupivacaine 2.5mg and Sufentanyl 2.5 mcg) in the intrathecal space. A non-blinded anesthesiologists will perform the anesthetics technique and leave the room immediately; a blinded anesthesiologists will do the data collection and act according to protocol if the patient in case of pain non controllable by the patient controlled anesthesia, in case of hypotension or any other possible complications. Data collection will take place before starting the locoregional anesthesia technique, at the moment when the anesthetists non blinded leaves the room, 10 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours after the start of the analgesia and at the moment of the expulsion of the baby. Patients and care providers will be blinded to which technic is being given. Data will be statistically analyzed using area under the curve and two-dimension variance analysis.

NCT ID: NCT05187962 Completed - Labor Pain Clinical Trials

Differential Sensory Block During Labor Epidural Analgesia: a Prospective Observational Study to Investigate the Relationship of Lower and Upper Sensory Block Levels to Cold With Sensory Block to Pinprick and Light Touch

Start date: December 21, 2021
Phase:
Study type: Observational

Epidural analgesia remains the gold standard for pain control during labor and delivery. Proper assessment of an epidural's level of blockade is important for providing safe and effective analgesia. Previous studies have established that the most commonly tested modality for adequacy of epidural blockade is a patient's sensory blockade to cold temperature. In a study performed at our institution, Soares et. al. (publication pending) documented two thresholds of sensory block to ice: one defined as the lower sensory block level, in which the patient is able to notice the cold sensation but perceives that it is not as cold as a control dermatome; the other defined as the upper sensory block level, in which the patient perceives that the cold sensation is at approximately the same temperature as if it were applied to a non-anesthetized area such as the neck or face. Although this a known finding to nurses and physicians assessing the sensory block to ice, this phenomenon and its magnitude has not been previously reported in epidural anesthesia. The goal of this study is to examine patients with labour epidurals and to determine the dermatomal relationship between the lower and upper sensory block levels to cold when compared with sensory blockade to both pinprick and light touch.

NCT ID: NCT05179915 Recruiting - Clinical trials for Labor Pain, Labor Perception, Hormone Levels and Childbirth Comfort

Effect of Therapeutic Touch on Labor Pain and Hormone Levels

Start date: March 8, 2022
Phase: N/A
Study type: Interventional

Levels of pain and anxiety experienced during labor are important factors affecting maternal and infant health. One indicator affecting these factors is labor-specific hormone levels in the uterus. Therapeutic touch practice is a CAT (Complementary and Alternative Therapies) method, and its effect on these factors will be a guide for future practice. The study participants will be women who are accepted to the delivery room of Adana Seyhan Public Hospital affiliated to Adana City Health Administrative of T.R. Ministry of Health between 01th of January 2022 and 01th of January 2023. The sample size of the study was calculated using G*power 3.1.9.6 program. Data obtained from the study conducted by Türkmen and Tuna Orhan (2021) were utilized for the effect size to be used for the calculation of the sample size. With d=0.86 effect size, 5% margin of error (α=0.05), 80% power (1-β=0.80), the sample size was calculated as 23 for the experimental group and 23 for the control group. Considering potential losses in the process, the sample size in both groups was increased by 10% and 25 pregnant women in each group were decided to be included in the study. An average of 15-minute therapeutic touch will be administered in the experimental group. As for the control group, they will be administered fake therapeutic touch for 15 minutes. Data will be collected using the pre and post-therapeutic touch hormone levels, Visual Analogue Scale (VAS), the Childbirth Comfort Scale (CCS), and spit sample. Maternal Perception of Labor Scale (MPLS) data will be collected after the administration is finished. Data will be analyzed using Social Sciences Statistical Package Program 20.0. Very few studies have been conducted on whether labor pain can be decreased effectively using therapeutic touch. However, there are no placebo-controlled and single-blind experimental studies that investigated the effect of therapeutic touch practice during labor on labor pain, labor perception, childbirth comfort, endorphin, oxytocin, and cortisol hormone levels. Therefore, this study will be conducted as a randomized-controlled study to investigate the effect of therapeutic touch on labor pain, labor perception, childbirth comfort, endorphin, oxytocin, and cortisol hormone levels.

NCT ID: NCT05169138 Completed - Labor Pain Clinical Trials

The Effect Of Lavender Essential Oil On Birth Pain

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

The study was planned as a randomized controlled trial to determine the effect of lavender oil applied to primiparous women by inhalation and massage methods on labor pain.

NCT ID: NCT05167383 Completed - Labor Pain Clinical Trials

Virtual Reality to Reduce Labor Pain

VRH4L
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Background and Goal of Study Labor pain remains an area where different analgesia options are looked for, more specifically non-pharmacological remedies are popular. Hypnosis and virtual reality (VR) have been studied with encouraging results. However, until now, the combination of VR and hypnosis (VRH) has not been assessed during labor, although it has shown promising results in other acute pain areas. The VRH4L study will evaluate the efficacy of Virtual Reality Hypnosis (VRH) in reducing pain during labor. Hypnosis is delivered as a standardized therapeutic intervention through virtual reality, using a digital sedation software (AQUA ®, Oncomfort SA). For this prospective, interventional parallel group, monocentric randomized controlled trial full term women who were planned for an induction of labor at the St-Jean Hospital in Brussels from March to May 2021 were included. Women with complicated pregnancies and patients with contraindications to VR were excluded. Patients were randomized in two arms. In the VRH group the patients received a 30-minute session of virtual reality hypnosis when in active labor and had access to standard care. Patients in the control group received only standard care. Primary outcome was the difference in post intervention pain score between the two arms. Secondary outcomes were the difference in pain score 30 minutes after the intervention, vital signs correlated to pain, satisfaction of the experience, interaction with the midwife and prevalence of side effects. Data was analyzed using the student's T test.

NCT ID: NCT05155826 Completed - Labor Pain Clinical Trials

Effect of Virtual Reality for Pain Management During Intracervical Balloon Placement for Artificial Childbirth Induction

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

The labor induction concerns 22% of births in France. In the event of labor induction, in almost two thirds of cases, a cervical ripening method is used and the use of mechanical methods is observed for 8% of cervical ripening. Intra-cervical balloon placement is generally well tolerated but is frequently associated with pain and acute anxiety. There are few options for pain relief. Virtual reality, a relatively new intervention, has been studied as a distraction technique for pain relief, but never in the context of the induction of childbirth.

NCT ID: NCT05149677 Recruiting - Labor Pain Clinical Trials

The Effect of Music Therapy on Labour Pain, Anxiety, and Analgesia

Start date: January 2022
Phase: N/A
Study type: Interventional

Labour pain is the result of complex and subjective interactions of multiple physiologic and psychosocial factors on a woman's interpretation of labour stimuli. It is an integral part of the labour process, often associated with anxiety and being subjective, affects each woman's experience of the birthing process in differing ways. This will be a randomized clinical trial, involving primiparous women presenting to the University Hospital of the West Indies (UHWI) for labour and delivery. Primiparous, term women in labour will be eligible and randomized in a 1:1 ratio to receive music plus standard of care during labour and standard care without music therapy. The primary outcome of this study will be to determine whether music therapy is an effective adjunct or alternative to pharmacological therapies for pain and anxiety management in labour. The secondary outcome would be to assess the effect of music on labour duration, operative delivery rates, abnormal foetal heart rate patterns and APGAR scores. Approximately 260 primigravida women would be recruited and invited to participate in this randomized clinical trial over an eight-month period.

NCT ID: NCT05136066 Completed - Labor Pain Clinical Trials

Effects of Massage With Peppermint Oil on Labor Pain

Start date: November 13, 2021
Phase: N/A
Study type: Interventional

Birth is a very special experience for a woman and her family. Labor pain is one of the strongest known and defined pains today. In the literature, it has been stated that labor pain is perceived as more severe than chronic pain such as low back pain, cancer pain, phantom pain and postherpetic neuralgia, and acute pain such as fracture or laceration. When birth pain is not controlled, the vicious cycle of stress, fear and pain can continue and affect the mother and fetus negatively. In this study, our aim is to determine the effect of applying peppermint oil diluted with pure natural olive oil to the abdomen and waist region by massage in labor pain, reducing the labor pain.