- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07585916
Prenatal Yoga Intervention in Pregnant Women
Effects of a Prenatal Yoga Intervention on Traumatic Childbirth Perception, Self-Perception, and Delivery Preferences in Pregnant Women
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
This study will be conducted with voluntary pregnant women aged 18 years and older, at or beyond the 16th week of gestation, and without a diagnosis of high-risk pregnancy. Participants will be randomly assigned to the intervention and control groups using a computer-generated simple randomization method (https://www.random.org/integers/
) to ensure unbiased allocation. The intervention group will consist of 8-12 participants per group, and the program will be implemented in three separate groups. Participants in the intervention group will receive a prenatal yoga program consisting of eight sessions delivered twice weekly, while the control group will receive routine prenatal care without any additional intervention from the researchers. Data collection instruments will be administered at baseline (pre-test), at the end of the eighth session (post-test), and at a one-month follow-up.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Duygu Özer, Asst. Prof
- Numer telefonu: +905061291978
- E-mail: duyguozer2016@hotmail.com
Lokalizacje studiów
-
-
Bartın
-
Bartın, Bartın, Turcja (Türkiye), 74100
- Rekrutacyjny
- Bartın University
-
Kontakt:
- Duygu Özer, Asst. prof
- Numer telefonu: +9 05061291978
- E-mail: duyguozer2016@hotmail.com
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Being at or beyond the 16th week of gestation (second trimester or later)
- Being aged 18 years or older
- Having no diagnosis of high-risk pregnancy based on obstetric evaluation
- Having no medical restriction on physical activity or yoga practice as determined by a physician
- Providing written informed consent after being informed about the study
Exclusion Criteria:
- Diagnosis of high-risk pregnancy (e.g., preeclampsia, placenta previa, premature rupture of membranes, risk of preterm birth, or other serious obstetric complications)
- Physician-imposed restriction on physical activity
- Presence of serious systemic conditions that would prevent participation in yoga practice
- Inability to complete the questionnaires reliably due to psychiatric or cognitive conditions
- Declining to participate or not providing informed consent
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Experimental
Prenatal Yoga Program was applied to the intervention group.
|
Participants in the intervention group received a structured prenatal yoga program consisting of eight sessions delivered twice weekly.
Each session lasted approximately 45 minutes and was conducted in accordance with safe prenatal exercise guidelines.
|
|
Brak interwencji: Control
Participants in the control group received routine prenatal care only and were not exposed to any structured intervention during the study period.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Traumatic Childbirth Perception Scale
Ramy czasowe: Baseline, immediately after the 8-week intervention, and 1 month post-intervention
|
The Traumatic Childbirth Perception Scale is a self-report instrument designed to assess perceptions of traumatic childbirth, including physical, emotional, and psychological aspects.
The scale consists of 13 items.
Each item is rated on a scale ranging from 0 to 10, and total scores range from 0 to 130, with higher scores indicating higher levels of perceived traumatic childbirth.
Mean total scores are used to interpret the level of traumatic childbirth perception.
The score ranges are categorized as follows: 0-26 (very low), 27-52 (low), 53-78 (moderate), 79-104 (high), and 105-130 (very high).
|
Baseline, immediately after the 8-week intervention, and 1 month post-intervention
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Pregnant Women's Self-Perception Scale
Ramy czasowe: Baseline, immediately after the 8-week intervention, and 1 month post-intervention
|
The scale consists of 12 items rated on a 4-point Likert scale ranging from 1 (never) to 4 (always).
It comprises two subscales: maternal perception related to pregnancy (7 items) and body perception during pregnancy (5 items).
Higher scores on the maternal perception subscale (range: 7-28) indicate higher levels of positive maternal perception.
In contrast, higher scores on the body perception subscale (range: 5-20) reflect more negative body perception during pregnancy.
|
Baseline, immediately after the 8-week intervention, and 1 month post-intervention
|
|
Preferred Mode of Delivery Scale for Pregnant Women
Ramy czasowe: Baseline, immediately after the 8-week intervention, and 1 month post-intervention
|
The scale is suitable for women without systemic or psychiatric disorders and who conceived naturally.
It consists of 18 items and three subscales: self-efficacy, normative beliefs, and preferences.
Items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Items 6-14 and 16-18 are reverse scored.
The total score is calculated by summing all item responses, and subscale scores can be obtained by summing the corresponding items.
The scale does not have a cut-off point.
Total scores range from 18 to 90, with higher scores indicating a stronger preference for vaginal delivery, as all items are scored in favor of vaginal birth for ease of interpretation.
|
Baseline, immediately after the 8-week intervention, and 1 month post-intervention
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- BARU-SBF-DO-4
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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