- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07571785
Showering During Labor
Effects of Showering During Labor on Pain, Anxiety, Comfort, Satisfaction, and Labor Outcomes: A Randomized Controlled Trial
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.
Přehled studie
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Istanbul
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Istanbul, Istanbul, Turecko (Türkiye), 34010
- State Obstetrics and Gynecology Hospital, Istanbul
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Women admitted to the labor unit during the study period
- Term pregnancy (37-41 weeks)
- Planned vaginal birth
- Cervical dilation greater than 5 cm
- Volunteered to participate and provided informed consent
Exclusion Criteria:
- Inability to communicate in Turkish
- Hearing or mental health conditions
- Conversion from vaginal birth to cesarean section
- Age under 18 years
- High-risk pregnancy (e.g., preeclampsia, diabetes, hypertension, multiple pregnancy, placental abnormalities)
- Use of epidural anesthesia
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Shower During Labor
Participants were allowed to shower during active labor (cervical dilation >5 cm) in a private bathroom within the labor room.
Showering was permitted at the participant's preference, for at least 20 minutes per session, with water temperature maintained between 35-40°C.
Safety measures were implemented, including accompaniment by a companion or researcher.
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Participants were allowed to shower during active labor (cervical dilation >5 cm) in a private bathroom within the labor room.
Showering was permitted at the participant's preference, for at least 20 minutes per session, with water temperature maintained between 35-40°C.
Safety measures were implemented, including accompaniment by a companion or researcher.
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Žádný zásah: Control: Routine Labor Care
Participants received routine intrapartum care without showering during labor.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Labor Pain Intensity
Časové okno: Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
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Pain intensity assessed using the Visual Analog Scale (VAS) during labor.
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Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Anxiety Level During Labor
Časové okno: Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
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Anxiety assessed using the Visual Analog Scale (VAS) during labor.
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Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
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Maternal Comfort During Labor
Časové okno: At 10 minutes after the first shower session during active labor
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Maternal comfort assessed using the Childbirth Comfort Questionnaire.
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At 10 minutes after the first shower session during active labor
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Birth Satisfaction
Časové okno: 2 hours postpartum.
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Birth satisfaction assessed using the Birth Satisfaction Scale.
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2 hours postpartum.
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Duration of Labor
Časové okno: From admission to the labor unit until delivery.
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Total duration of labor measured in hours, obtained from clinical records.
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From admission to the labor unit until delivery.
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Mode of Delivery
Časové okno: At delivery.
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Type of delivery (vaginal or cesarean) recorded from clinical records.
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At delivery.
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Use of Obstetric Interventions
Časové okno: During labor and recorded at delivery.
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Use of obstetric interventions (e.g., induction, augmentation, episiotomy) recorded from clinical records.
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During labor and recorded at delivery.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- Showering During Labor
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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