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Tundra lists 16 Childbirth clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
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NCT07015086
The Effects of Positive Birth Experience Sharing and Guided Imagery on Childbirth Self-Efficacy and Fear of Childbirth
Brief Summary This randomized controlled trial evaluates the effects of positive birth experience sharing combined with guided imagery on fear of childbirth and childbirth self-efficacy in primiparous pregnant women. The study is a single-center, two-arm, parallel-group randomized controlled trial using stratified block randomization based on baseline fear of childbirth. A total of 62 pregnant women were randomized in a 1:1 ratio to the intervention group (n=31) or control group (n=31). Participants were enrolled at 26-28 weeks of gestation. Before randomization, participants completed the Personal Information Form, the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A), and the Childbirth Self-Efficacy Inventory-Short Form (CBSEI-C32) online. Participants were stratified according to their baseline W-DEQ-A scores and then randomly allocated to the intervention or control group. The intervention was delivered individually and online via WhatsApp. Women in the intervention group participated in an approximately 30-minute individual online session during which one of the researchers shared a positive personal birth experience and answered participants' questions about childbirth. Participants were also provided with a standardized Turkish guided imagery audio recording based on childbirth-focused guided imagery techniques. They were instructed to listen to the approximately 20-minute recording independently once or twice daily for 10 weeks, preferably before bedtime. Daily WhatsApp reminders and a guided imagery exercise follow-up chart were used to support and monitor adherence. Women in the control group received routine antenatal care and did not receive the positive birth experience sharing or guided imagery intervention. At the end of the 10-week intervention period, participants in both groups completed the W-DEQ-A and CBSEI-C32 online. Within the first three days after childbirth, the W-DEQ-B was administered online and mode of birth was recorded.
Gender: FEMALE
Ages: 18 Years - Any
Updated: 2026-09-09
1 state
NCT07267351
Determining the Effect of the ThetaHealing Meditation Method Given During the Antenatal Period on Labor Pain and Fear in Primiparous Women
PurposeThis randomized controlled trial (RCT) aims to evaluate the effects of antenatal ThetaHealing meditation training on labor pain and childbirth fear among primiparous women.ObjectivesTo enhance childbirth satisfaction by enabling laboring women to utilize the ThetaHealing meditation technique during delivery.To assess the efficacy of ThetaHealing meditation in alleviating labor pain and fostering pain adaptation.To evaluate the impact of ThetaHealing meditation on reducing childbirth fear and enhancing psychological coping mechanisms during labor.To optimize intrapartum comfort via ThetaHealing meditation, thereby promoting spontaneous vaginal delivery.Background and HypothesesLabor pain and fear of childbirth (tokophobia) significantly influence maternal delivery preferences. Exposure to negative birth narratives often instills maladaptive beliefs, leading women to anticipate traumatic, high-risk birth outcomes. Implementing antenatal ThetaHealing meditation aims to cultivate positive cognitive reframing, thereby improving maternal comfort during labor.Furthermore, continuous midwifery support enhances maternal self-efficacy and emotional security, which directly impacts delivery outcomes. Although empirical literature regarding intrapartum electroencephalographic (EEG) activity remains limited, clinical observations suggest that routine hospital admissions-characterized by continuous electronic fetal monitoring (NST), bright lighting, and procedural interventions-predominantly induce beta-wave activity associated with heightened stress and anxiety. Transitioning to a low-stimulus environment with continuous midwifery care may facilitate a shift toward alpha brainwave activity ($8\\text{--}12\\text{ Hz}$), promoting relaxation. Under self-paced labor conditions, women may further transition into theta-wave activity ($4\\text{--}8\\text{ Hz}$), a state of heightened intuition, reduced distress, and somatic attunement.Given the lack of quantitative neurophysiological data during labor, this study utilizes EEG monitoring to track maternal brainwave frequencies during ThetaHealing meditation. By evaluating the method's efficacy in fostering alpha and theta frequencies, this research seeks to mitigate unnecessary cesarean deliveries, alleviate childbirth fear and pain, and address a key gap in the neuro-obstetric literature.Key Enhancements:Randomized controlled study $\\rightarrow$ Randomized controlled trial (RCT): Standard medical abbreviation.Childbirth fear $\\rightarrow$ Fear of childbirth (tokophobia): Incorporates accepted clinical terminology.Surrender $\\rightarrow$ Somatic attunement / Psychological coping: Replaced the non-clinical concept of "surrender" with precise biobehavioral language suitable for medical journals.Brain wave $\\rightarrow$ Brainwave frequency / EEG activity: Standard neurophysiological terms.
Gender: FEMALE
Ages: 18 Years - 35 Years
Updated: 2026-09-01
NCT07793136
Fetal Images Through Virtual Reality During Labor
Aim: This randomized controlled trial aims to evaluate the effect of viewing personalized fetal images through a virtual reality (VR) headset during labor on childbirth comfort, maternal attachment, and perceived traumatic childbirth. Methods: The study will include primiparous pregnant women at 28-32 weeks of gestation who voluntarily agree to participate and provide consent for fetal image recording. Participants will be randomly assigned to an intervention group or a control group. During labor, women in the intervention group will view their own personalized fetal images accompanied by fetal heart sounds through a VR headset for at least four minutes, with the option to continue viewing if desired. The control group will receive routine intrapartum care. Data will be collected using the Pregnant Woman Descriptive Information Form, Childbirth Comfort Questionnaire, Maternal Attachment Scale, and Traumatic Childbirth Perception Scale. Data will be analyzed using appropriate statistical methods, including independent-samples t-test, paired-samples t-test, and chi-square test, as appropriate. Statistical significance will be set at p \< 0.05.
Gender: FEMALE
Ages: 18 Years - 35 Years
Updated: 2026-08-28
NCT07533448
Effects of Nada Yoga Music and Mandala Coloring During Labor on Pain, Anxiety, and Maternal Outcomes
Aim: The aim of this study is to evaluate the effect of mandala coloring on labor pain, childbirth experience, and maternal satisfaction in pregnant women. Materials and Methods: This study was conducted as a randomized controlled trial with a pretest-post test group design including measurements at multiple time points. The study population consisted of pregnant women admitted for vaginal delivery to the labor unit of a hospital between June 1, 2025, and May 1, 2026. Sample size was calculated using the G\*Power 3.1.9.7 program. In the sample size calculation, the Cohen's d = 0.80 value obtained from the reference study was used as the basis and was converted to an approximate effect size of f = 0.40. Analysis performed with a 5% significance level and 80% statistical power indicated that the required minimum sample size for the three groups was 66 participants in total. To prevent potential data loss, support voluntary participation, and increase statistical power, 36 participants were initially planned for each group; however, because one participant in each intervention group was younger than 18 years of age and was therefore excluded, the study was completed with a total of 106 participants in the mandala coloring (n = 35), Nada Yoga music (n = 35), and control (n = 36) groups.
Gender: FEMALE
Ages: 18 Years - Any
Updated: 2026-08-26
1 state
NCT07753746
Effects Of Tele-PFME On Urinary Incontinance, Pelvıc Floor Functions and Childbirth
The aim of this study is to examine the effect of pelvic floor exercises performed via prenatal tele-rehabilitation on the following issues: 1. Perceived symptom severity and frequency associated with the development of urinary incontinence and quality of life 2. Pelvic floor muscle function and 3. Birth and delivery parameters in pregnant women. Research Questions 1\. Does prenatal tele-pelvic floor exercise reduce the frequency or symptom severity of urinary incontinence in the late stages of pregnancy and the early postpartum period? 2. Does prenatal tele-pelvic floor exercise improve pelvic floor muscle function and contraction performance? 3. Does prenatal tele-pelvic floor exercise affect delivery parameters such as labor duration, mode of delivery, episiotomy, and perineal trauma? The current literature indicates that prenatal tele-pelvic floor exercise can reduce the risk of urinary incontinence during pregnancy and the postpartum period by preserving pelvic floor muscle function in pregnant women, and recommends the application of pelvic floor muscle exercises and pelvic floor training during pregnancy due to their protective effect. However, more data are needed to draw meaningful conclusions about the participation (continuity) of PTKE in treatment, how and by whom it is administered, and its effects on postnatal UI. In addition to preventing UI, studies are needed that more clearly express the effects of antenatal PTKE, such as improved quality of life specific to UI with a reduction in the severity, frequency, and amount of leakage, and the determination of changes in pelvic floor muscle strength and function in the long term. There are studies that mention various content regarding education and exercise practices. With the Covid-19 conditions, the way healthcare institutions operate has been visibly affected. Based on this, potential situations such as individuals not being able to benefit sufficiently from healthcare facilities may occur. Investigators believe that tele-rehabilitation methods will provide us with positive support in this regard, in terms of reaching individuals and providing healthcare services to individuals during the thesis study. Furthermore, more studies are needed on the effects of PTKE programs conducted through tele-health applications on treatment participation, patient adherence to treatment, and prenatal/postnatal urinary tract infection. Evidence from research on application/tele-rehabilitation-based pelvic floor muscle exercises in women during pregnancy and the postnatal period shows potential benefits in terms of adherence and symptom management, but the literature is less mature than the literature on general pelvic floor muscle exercises. The aim of this study is to investigate the effectiveness of a tele-rehabilitation-supervised pelvic floor muscle exercise program (PFME) in preventing urinary incontinence during pregnancy and postpartum, and its effects on pelvic floor function, strength, and delivery parameters. Hypotheses H0 (primary): In pregnant women, a structured tele-rehabilitation-based pelvic floor muscle exercise (PFME) program does not differ from a home exercise program in terms of its effect on urinary incontinence symptoms in the late pregnancy and early postpartum period. H1 (primary): In pregnant women, a structured tele-rehabilitation-based PFME program reduces urinary incontinence symptoms in the late pregnancy and early postpartum period compared to a home exercise program. H0 (primary): In pregnant women, a structured tele-rehabilitation-based pelvic floor muscle exercise (PFME) program does not differ from a home exercise program in terms of its effect on pelvic floor muscle function in the late pregnancy and early postpartum period. H 2 (primary): In pregnant women, a structured tele-rehabilitation-based PFME program improves pelvic floor muscle function in late pregnancy and early postpartum compared to a PFME program given as a home exercise program.
Gender: FEMALE
Ages: 18 Years - 35 Years
Updated: 2026-08-07
NCT04989894
Quality of Recovery After Childbirth
In this proposed study, the investigators hope to assess the quality of recovery after delivery in a local population that would take into account physiological and psychological parameters to better understand the recovery process after delivery. The investigators will identify risk factors, especially those that are modifiable and associated with a poorer ObsQoR score and hence a poor quality of recovery after delivery. This data may then be used to educate women and manage expectations in the postpartum period, and help develop potential therapeutic interventions.
Gender: FEMALE
Ages: 21 Years - 50 Years
Updated: 2026-08-07
NCT06550570
Evaluation of the Impact of Ambulatory Epidural on Maternal Satisfaction During Delivery and Postpartum
Childbirth is a special event for women. Maternal satisfaction regarding childbirth is quite important, that is why this factor has to be taken into account. A bad experience related to childbirth could lead to serious psychological and organic consequences such as postpartum depression, mother-baby bond deterioration and chronic pelvic pain. Childbirth image changed over the years to the extent that an increasingly physiological process keeping analgesia and safety is more and more desired. In this perspective, this study aims to investigate an approach so-called ambulatory epidural. Indeed, only a few studies have been conducted and the ones published in 1990s did not involve the current recommended pharmacological protocols.
Gender: FEMALE
Ages: 18 Years - Any
Updated: 2026-06-24
NCT07652957
Comparison Of The Effects Of Swedish Massage With Natural Oils
Aim: This study aimed to evaluate the effects of Swedish massage combined with lavender and chamomile oils on childbirth outcomes during the first and second stages of labor. Materials and Methods: This randomized controlled experimental study was conducted with 90 pregnant women. Participants were randomly assigned to three groups: Intervention A (n=30; carrier oil + chamomile oil + Swedish massage), Intervention B (n=30; carrier oil + lavender oil + Swedish massage), and Control (n=30; carrier oil + Swedish massage). Data were collected using the Individual Identification Form, Vital Signs (blood pressure and pulse), Partograph, Visual Analog Scale (VAS) for pain, State-Trait Anxiety Inventory (STAI-I and STAI-II), and the Childbirth Fear Scale. Statistical analyses were performed using IBM SPSS Statistics Version 23.0. The study was designed to compare the effects of Swedish massage combined with chamomile oil, lavender oil, or carrier oil on labor pain, anxiety, childbirth fear, physiological parameters, and selected birth outcomes during the first and second stages of labor.
Gender: FEMALE
Ages: 18 Years - 40 Years
Updated: 2026-06-17
1 state
NCT07571785
Showering During Labor
This study examined whether showering during labor affects pain, anxiety, comfort, satisfaction, and labor outcomes in women undergoing vaginal birth. Non-pharmacological methods are commonly used to support women during labor, and warm showering may help reduce discomfort and emotional distress during the labor process. In this randomized controlled trial, pregnant women in active labor were assigned either to a shower group or to a control group receiving routine labor care. Women in the shower group were allowed to shower during labor under standardized conditions, while the control group received routine intrapartum care without showering. Pain and anxiety levels were assessed repeatedly during labor, while comfort and birth satisfaction were evaluated during and after birth using validated measurement tools. The results of this study aim to contribute to evidence-based intrapartum care practices by evaluating the role of showering as a supportive intervention during labor.
Gender: FEMALE
Ages: 18 Years - Any
Updated: 2026-05-06
1 state
NCT06542744
Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up
The goal of this clinical investigation is to learn if training with Emagina device can improve flexibility of the perineum during childbirth with the help of a balloon that inflates in the genital area according to a time-limited exercise program specifically developed to optimize results, in adult, pregnant women with their first child (single fetus) less than 24 weeks of amenorrhea at the time of inclusion (i.e. during the 5th month of pregnancy). The main questions it aims to answer are: * Does the Emagina training program improve perineal flexibility during pregnancy ? * Does the Emagina training program reduce the proportion and importance of perineal tears, as well as the proportion of sutures and episiotomies during childbirth ? Researchers will compare Emagina group to a Control group (no intervention) to see if Emagina device works to improve perineum flexibility. Participants will : * measure the flexibility of their perineum on 2 occasions 90 days apart, with or without perineal training * perform perineal training with the Emagina medical device or follow current practice * fill out e-questionnaires regarding quality of life, lifestyle, pelvic static disorders, sexual activity and urinary incontinence
Gender: FEMALE
Ages: 18 Years - Any
Updated: 2026-05-05
NCT07358026
EARLY-PREG: A Preconception Cohort Study Based on Counterfactuals to Study Maternal-Embryonic Molecular Interactions
EARLY-PREG is an open-cohort clinical study with a preconception, longitudinal, bidirectional and counterfactual design. The aim of this cohort is to investigate the proteomic signatures of maternal-embryonic communication by interrogating a growing biorepository of maternal fluids and tissues collected during the first two weeks after fertilisation. Participants in the EARLY-PREG cohort consist of healthy couples seeking pregnancy, as well as women who are not seeking to conceive. The three main outcomes in the cohort are defined according to menstrual cycles in which conception is achieved and those in which conception is not achieved. Their clinical definitions are as follows: * Pregnancy with a full-term live birth refers to the cycle in which the ovum is fertilised, leading to pregnancy, with beta-hCG levels above the clinical threshold for a positive pregnancy test. * Early pregnancy loss refers to a miscarriage up to 12 6/7 weeks. * Non-pregnancy refers to a menstrual cycle in which conception does not occur, confirmed by a clinically negative beta-hCG test. When referring to the same individual, this is, by definition, considered the counterfactual to the corresponding conception cycle.
Gender: FEMALE
Ages: 18 Years - 40 Years
Updated: 2026-04-29
NCT05373342
Feasibility Study to Evaluate the Role of a Novel Device in Childbirth
Accidentally retained surgical items or swabs are well-recognised errors that result in adverse consequences for patients. This error is one of the commonest "Never Events" - patient safety incidents that are considered preventable. Although uncommon, these incidents can have devastating consequences. Retained surgical items have 70% re-interventions, reaching 80% morbidity and 35% mortality. Swabs or sponges are like small towels that soak up blood and body fluids so that the surgeon can visualise the operating area effectively. Swabs are used in all areas of surgery which include operations on the tummy, chest, limbs. They are also used in the vagina during childbirth, to assess for tears and to minimise blood oozing from the vagina. The common risk factors for this error are out of hours surgical or childbirth procedures, multiple handovers in the care of the patient, raised BMI (Body Mass Index) and unplanned change to the operative intervention. As the name suggests, a 'never event' should never happen in the first place. Never. Unfortunately, this is not the case. Incidents involving surgical swabs being left behind, particularly during a caesarean section or a perineal repair following a vaginal birth, are still happening despite over 100 years of institutional awareness of the problem and tentative solutions being implemented in clinical practice. never-event incidents involving retained surgical swabs are a widespread problem affecting healthcare systems worldwide. It is therefore reasonable to ask the question: why are surgical swabs being left behind and what can be done to prevent this from happening?
Gender: FEMALE
Ages: 18 Years - Any
Updated: 2026-04-09
NCT07446699
The Effect of Pushing Techniques Used During Childbirth on Women's Labor Duration, Pain, and Fatigue Levels
The Effect of Pushing Techniques Used During Childbirth on Women's Labor Duration, Pain, and Fatigue Levels
Gender: FEMALE
Ages: 19 Years - 35 Years
Updated: 2026-04-08
NCT06847308
Visual Biofeedback Through Transperineal Ultrasound During the Expulsive Phase of Labour to Improve Maternal Childbirth Satisfaction
Childbirth is generally regarded as a positive life-changing experience. Up to 44% of women may however experience this as a traumatic event, with 3% suffering from post-traumatic stress disorder after childbirth. The aetiology of a traumatic childbirth experience is a complex interplay between pre-birth, intra-partum and postnatal factors. Feelings of loss of control, lack of interaction with the obstetric caregiver and lack of emotional or practical support during labour are important contributing factors. This trial aims to investigate the effect of providing Visual Biofeedback (VB) through Trans-Perineal Ultrasound (TPU) during the active 2nd stage of labour on maternal childbirth satisfaction. The hypothesis is that the intervention will improve patient-caregiver communication and enhance parturient women's sense of control and empowerment, ultimately improving the birth experience.
Gender: FEMALE
Updated: 2025-02-26
1 state
NCT05797363
The Effect of Continuous Midwife Support on Various Parameters Related to Pregnancy, Childbirth and Postpartum Period
There is a need for studies with a high level of evidence regarding the effect of supportive care given during the preconceptional period, pregnancy, childbirth and postpartum processes. With this planned study, it is aimed to evaluate the effect of continuous midwife support during pregnancy, birth and postpartum periods, starting from the preconceptional period, on various parameters related to pregnancy, birth and postpartum period. The research is planned as a randomized controlled experimental study. It consists of two groups, the study group and the control group. 75 women out of 150 women will form the control group and 75 women will form the study group. The women in the working group will be given individual training in line with their needs. Data will be collected by using the checklist and many scales used by the control and study groups in preconceptional counseling recommended by ACOG (American College of Obstetricians and Gynecologists).
Gender: FEMALE
Ages: 19 Years - 35 Years
Updated: 2023-04-04
NCT05009433
HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children
Regular exercise during pregnancy and postpartum leads to health benefits for mother and child. Inactivity during pregnancy and after delivery is now treated as risky behavior. Physically active pregnant women significantly less often suffer from, among others, gestational diabetes, excessive weight gain, lipids disorders, hypertension, preeclampsia, depressive symptoms, functional and structural disorders, including stress urinary incontinence, back pain or diastasis recti abdominis (DRA). Prenatal physical activity reduces the risk of premature delivery and miscarriage, fetal macrosomia, complications in labor or the risk of metabolic disorders in children. High-intensity interval training (HIIT) has become one of the most popular trends in the fitness sector. The effectiveness of HIIT on a number of health indicators has been proven in various populations but limited data are available on HIIT during pregnancy. The first hypothesis is that the HIIT, implemented during pregnancy and after childbirth, as a stronger exercise stimulus, will have a better impact on selected biological and psychological parameters of mothers, as well as on selected health parameters of their children, compared to the MICT (moderate intensity continuous training). Therefore, it promises better preventive effects on pregnancy complications and ailments as well as non-communicable diseases occurring in these populations. In the second hypothesis, it was assumed that HIIT and MICT implemented during pregnancy and after childbirth, tailored to the specific needs of the perinatal period, will not differ in the effectiveness of maintaining normal functional parameters in women, including prevention of urinary incontinence, back pain, DRA, etc. Pregnant women who apply for the study will be divided into three groups: those attending the HIIT, MICT or educational programs. During the study, the participants will be under standard obstetric care. As comparative groups, non-pregnant women will be also recruited. The investigators will collect data on selected biological, functional and psychological parameters in the study women at each trimester of pregnancy, during the puerperium and one year after childbirth. The data from the medical documentation on the course of childbirth and the assessment of the new-born, as well as the results of preventive examinations in the study women's children aged one, two, four and six years will be also analyzed.
Gender: FEMALE
Ages: 18 Years - 45 Years
Updated: 2022-12-02
1 state