- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07566026
Breathing Exercises During Labor and Maternal Outcomes
Effects of Breathing Exercises During Labor on Maternal Stress, Satisfaction, and Birth Outcomes: A Randomized Controlled Trial
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Labor is a physiological process that may be accompanied by pain, anxiety, and psychological stress, which can negatively affect birth satisfaction and labor outcomes. Non-pharmacological interventions such as breathing exercises are widely used to support women during labor.
In this randomized controlled experimental study, pregnant women admitted to the labor and delivery unit during the latent phase were randomly assigned to either an experimental group receiving guided breathing exercises throughout labor or a control group receiving routine intrapartum care only. Breathing exercises were applied continuously during uterine contractions until full cervical dilatation.
Maternal pain intensity, anxiety, traumatic birth perception, birth satisfaction, and labor outcomes including labor duration and obstetric interventions were assessed using validated measurement tools. The study aimed to determine whether breathing exercises could improve maternal psychological well-being, enhance birth satisfaction, and positively influence labor outcomes.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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-
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Istanbul, Turecko (Türkiye)
- Nilgün Avcı
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Pregnant women admitted to the labor and delivery unit during the latent phase
- Women planning vaginal birth
- Volunteered to participate
Exclusion Criteria:
- Women who did not speak Turkish
- Women with auditory or mental health problems
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: Breathing Exercise Group
Participants received guided breathing exercises throughout labor in addition to routine intrapartum care.
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Pregnant women were instructed and guided to perform slow, controlled breathing exercises during each uterine contraction from the latent phase until full cervical dilatation.
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Žádný zásah: Routine Care Group
Participants received routine intrapartum care only.
No breathing exercises were applied.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Birth Satisfaction
Časové okno: During the fourth stage of labor (within 2 hours after birth).
|
Birth satisfaction assessed using the Short Form of the Birth Satisfaction Scale (BSS-R). Scores range from 0 to 40; higher scores indicate greater satisfaction. |
During the fourth stage of labor (within 2 hours after birth).
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Labor Pain Intensity
Časové okno: Repeatedly during labor from admission to the labor unit until delivery.
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Pain intensity measured using the Visual Analog Scale (VAS).
Scores range from 0 to 10; higher scores indicate more severe pain.
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Repeatedly during labor from admission to the labor unit until delivery.
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Labor-Related Anxiety
Časové okno: During the fourth stage of labor (within 2 hours after birth).
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Anxiety measured using the Oxford Worries About Labour Scale.
Scores range from 10 to 40; higher scores indicate greater anxiety.
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During the fourth stage of labor (within 2 hours after birth).
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Traumatic Birth Perception
Časové okno: At admission to the labor unit (baseline) and during the fourth stage of labor (within 2 hours after birth).
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Traumatic birth perception measured using the Traumatic Birth Perception Scale.
Scores range from 0 to 130; higher scores indicate greater traumatic perception.
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At admission to the labor unit (baseline) and during the fourth stage of labor (within 2 hours after birth).
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Fetal Heart Rate During NST
Časové okno: During the NST monitoring session (approximately 20 minutes, same visit).
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Fetal heart rate assessed from NST recordings during the monitoring session.
Measured in beats per minute; normal patterns indicate better fetal well-being.
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During the NST monitoring session (approximately 20 minutes, same visit).
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Fetal Movement Count During NST
Časové okno: During the NST monitoring session (approximately 20 minutes, same visit).
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Number of fetal movements recorded by the mother using the event marker during NST monitoring. Higher counts indicate greater fetal activity. |
During the NST monitoring session (approximately 20 minutes, same visit).
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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
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Effects of Breathing Exercises
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