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4 clinical studies listed.

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Postpartum Women

Tundra lists 4 Postpartum Women clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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NOT YET RECRUITING

NCT07445711

Effect of Guided Imagery and AI-Assisted Video on Pain During Uterine Involution Assessment in Postpartum Women: A Randomized Controlled Trial

Uterine involution, the process by which the uterus returns to its pre-pregnancy size during the postpartum period, can cause severe cramp-like pain in postpartum women. Although pharmacological methods are common for managing this pain in the literature, their side effects limit their use in this population. This project aims to fill a significant gap in the literature by combining guided imagery, a non-pharmacological technique, with evolving artificial intelligence (AI) technologies. While the effectiveness of guided imagery in cesarean and labor pain is well-known, its impact on pain and physiological parameters during uterine involution-specifically through AI-supported visualization-will be evaluated for the first time within the scope of this study. The primary research question of the project is: "Do guided imagery and AI-supported video applications have a healing effect on the pain levels and vital signs of postpartum women during the evaluation of uterine involution?" This research is a three-arm, randomized controlled experimental study to be conducted at Istanbul Atlas University Hospital. The sample size of the study was determined using the G\*Power 3.1 program. As a result of the a priori power analysis performed by selecting the "ANOVA: Fixed effects, omnibus, one-way" statistical test under the "F tests" family, the significance level was set at α = 0.05, the statistical power (1-β) at 0.80, and the effect size (f) at 0.25 (medium effect). The analysis indicated a total sample size of 159 participants for the three groups, with 53 participants required in each group. To account for potential sample attrition, a 10% addition was made to each group, resulting in a planned study with 59 participants per group and a total of 177 participants. "Guided Imagery" and "AI-Supported Video" applications will be utilized as intervention methods. In the guided imagery group, an expert-approved original audio script titled "The Emotional Journey of Mother and Baby" will be played to the women via over-ear headphones during the uterine involution assessment. In the AI-supported video group, a video generated with AI prompts based on the same script will be shown using virtual reality (VR) goggles during the assessment. This will allow for a comparative analysis of the effects of visual and auditory stimuli on pain during the uterine involution evaluation. Participants' pain levels will be measured using the VAS scale, and physiological data (pulse, blood pressure, SpO₂) will be recorded by monitoring at the 60th, 120th, and 180th seconds of the involution process. Considering the moderating effect of anxiety on pain threshold and vital signs, the 'Postpartum Specific Anxiety Scale' will be administered to all participants before the intervention. Data will be analyzed using ANOVA and Kruskal-Wallis tests in the SPSS 23 program.

Gender: FEMALE

Ages: 18 Years - Any

Updated: 2026-03-03

Uterine Involution
Guided Imagery
Artificial Intelligence (AI)
+1
RECRUITING

NCT06911372

The Impact of Gestational Diabetes Mellitus on Cerebral Blood Flow and Cerebrovascular Function After Pregnancy

Gestational Diabetes Mellitus (GDM) currently affects approximately 14% of all pregnancies worldwide. Importantly, the health-related consequences of GDM extend well beyond pregnancy, such that women with a history of GDM have a 40% increased risk of cerebrovascular diseases and a 67% increased risk of dementia, compared to women with a history of uncomplicated pregnancy. Women with a history of GDM have impaired skin microvascular function, compared with women with a history of uncomplicated pregnancy. Therefore, it's likely that GDM results in impaired brain blood vessel function, yet there is little-to-no information regarding the effects of GDM on brain blood vessel health and function after pregnancy. Therefore, the purpose of the study is to evaluate the effects of GDM on brain blood flow and brain blood vessel function in healthy women with either a history of GDM or uncomplicated pregnancy. In this study, the investigators will use two different types of ultrasound to non-invasively measure brain blood flow. Brain blood vessel function will be evaluated by examining the brain blood flow responses to increases in carbon dioxide (the increases in carbon dioxide are similar to what is experienced during a breath hold). Additionally, the investigators will compare the brain blood flow results to skin microvascular function to explore potential mechanisms behind possible impairments in brain blood vessel function. Skin microvascular function will be assessed using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) on dime sized areas of the forearm. Finally, for screening purposes and to further explore potential mechanisms behind any potential impairments in brain blood vessel function, the investigators will perform blood draws to determine the metabolic health of the participants and to analyze for substances that influence blood vessel function.

Gender: FEMALE

Ages: 18 Years - 50 Years

Updated: 2025-12-16

1 state

Gestational Diabetes Mellitus (GDM)
Postpartum Women
Uncomplicated Pregnancy
NOT YET RECRUITING

NCT07139704

The Effect of Mindfulness-Based Sexual Counseling on Body Appreciation, Sexual Distress, and Sexual Self-Confidence in Postpartum Women With Episiotomy

Aim: This study will aim to evaluate the effect of mindfulness-based sexual counseling on body appreciation, sexual distress, and sexual self-confidence in postpartum women with episiotomy. Method: This randomized controlled experimental study will include participants assigned to intervention and control groups. The intervention group will receive a four-week mindfulness-based sexual counseling program consisting of eight sessions, while the control group will receive routine care. Body Appreciation, Sexual Distress, and Sexual Self-Confidence scales will be administered as pre- and post-tests.

Gender: FEMALE

Ages: 18 Years - 49 Years

Updated: 2025-08-24

1 state

Postpartum Women
ACTIVE NOT RECRUITING

NCT06786481

Effect of Foot Massage Performed to the Mother After Bırth on Breastfeedıng Success, Sleep Qualıty and Newborn Stress

Aim: To Reveal The Effect Of Foot Massage Performed To The Mother After Bırth On Breastfeedıng Success, Sleep Qualıty And Newborn Stress Material and Method: This randomized controlled trial was conducted with 70 people (35 experimental, 35 control) in a public hospital in Kahramanmaraş.

Gender: FEMALE

Updated: 2025-01-22

Postpartum Women