- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07694856
Effects of Warm Shower on Lactation, Fatigue, and Maternal Burnout (WARM-SHOWER)
The Effect Of Warm Showers On Exhaustıon, Fatigue, Lactation Onset Symptoms and Breast Milk Quantity In The First Three Postpartum Days: A Randomized Controlled Trial
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This study is a single-center, parallel-group randomized controlled trial designed to evaluate the effects of warm shower application during the first three postpartum days on maternal burnout, fatigue, lactation onset indicators, and breast milk intake among women who underwent cesarean birth. The intervention is based on the premise that warm water exposure may promote relaxation, improve physical comfort, reduce fatigue and stress, and support physiological mechanisms associated with lactation. The study aims to determine whether a structured warm shower intervention can improve maternal well-being and breastfeeding-related outcomes during the early postpartum period.
Eligible participants for the study are first-time mothers who have had a cesarean delivery and meet the study's inclusion criteria. Following the baseline assessment, participants are randomly assigned in a 1:1 ratio to either the intervention group or the control group. Women in the intervention group receive routine postpartum care plus a standard warm shower (37-39°C, 10-15 minutes) once daily at 24, 48, and 72 hours after delivery, as well as on days 7 and 14 postpartum, while women in the control group receive only routine postpartum care. Outcome assessments are conducted at baseline, immediately following the intervention, at 24, 48, and 72 hours postpartum, and during follow-up visits on the 7th and 14th days postpartum.
Maternal burnout is evaluated using the Maternal Burnout Scale, while fatigue is assessed using the Visual Analogue Scale for Fatigue. Lactation onset indicators are assessed through breast fullness and milk secretion characteristics, and infant breast milk intake is evaluated using the IMDAT Breast Milk Intake Scoring System. Data are analyzed using appropriate repeated-measures statistical methods to examine changes over time, between-group differences, and group-by-time interactions. The study aims to provide evidence regarding the effectiveness, safety, and clinical applicability of a low-cost, non-pharmacological postpartum care intervention that may support maternal recovery and breastfeeding outcomes.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Karatay
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Konya, Karatay, Turecko (Türkiye)
- Kto Karatay University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Having given birth between 37 and 42 weeks of gestation
- Having had a cesarean delivery
- Being a primipara
- Being admitted to the postpartum ward within the first 6 hours
- No physical or cognitive limitations preventing the ability to shower
- Providing written informed consent
Exclusion Criteria:
- Premature infant or infant in the neonatal intensive care unit
- Maternal history of infection, complications, or psychiatric diagnosis
- Physiological condition preventing breastfeeding
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Warm Shower + Routine Postpartum Care
Participants receive routine postpartum care plus a standardized warm shower intervention during the first three postpartum days.
Women in the intervention group are instructed to take a warm shower (37-39°C) once daily for 10-15 minutes following confirmation of clinical stability and mobilization readiness.
The intervention is delivered in addition to routine postpartum care and is intended to promote relaxation, physical comfort, maternal well-being, and lactation-related outcomes during the early postpartum period.
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Participants receive routine postpartum care in addition to a standardized warm shower (37-39°C, 10-15 minutes) once daily during the first three postpartum days after cesarean birth.
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Žádný zásah: Routine Postpartum Care (Control)
Participants in the control group receive routine postpartum care according to hospital protocol, including standard maternal and newborn monitoring, breastfeeding support, and postpartum recovery care.
No warm shower intervention is administered.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Maternal Burnout
Časové okno: Assessed at baseline (6-12 hours postpartum), immediately after the intervention, and at 24, 48, and 72 hours postpartum, as well as on postpartum days 7 and 14.
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Maternal Burnout Scale (MBS).
The Maternal Burnout Scale was used to assess maternal burnout levels.
The scale consists of 15 items rated on a 4-point Likert scale and includes the dimensions of physical and emotional exhaustion, emotional distancing from the child, and reduced maternal accomplishment.
Higher scores indicate higher levels of maternal burnout.
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Assessed at baseline (6-12 hours postpartum), immediately after the intervention, and at 24, 48, and 72 hours postpartum, as well as on postpartum days 7 and 14.
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Lactation Onset Indicators
Časové okno: Assessed at baseline (6-12 hours postpartum), immediately after the intervention, and at 24, 48, and 72 hours postpartum, as well as on postpartum days 7 and 14.
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Lactation onset indicators will be assessed as a composite outcome using the Lactation Assessment Form, which includes breast fullness, milk secretion characteristics, and post-feeding breast status.
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Assessed at baseline (6-12 hours postpartum), immediately after the intervention, and at 24, 48, and 72 hours postpartum, as well as on postpartum days 7 and 14.
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Postpartum Fatigue
Časové okno: Assessed at baseline (6-12 hours postpartum), immediately after the intervention, and at 24, 48, and 72 hours postpartum, as well as on postpartum days 7 and 14.
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Postpartum fatigue will be assessed using the Visual Analogue Scale for Fatigue (VAS-F), an 18-item instrument designed to assess fatigue.
Higher scores indicate greater postpartum fatigue.
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Assessed at baseline (6-12 hours postpartum), immediately after the intervention, and at 24, 48, and 72 hours postpartum, as well as on postpartum days 7 and 14.
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Infant breast milk intake score
Časové okno: Assessed at baseline (6-12 hours postpartum), immediately after the intervention, at 24, 48, and 72 hours postpartum, and on postpartum days 7 and 14.
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Infant breast milk intake will be assessed using the IMDAT Breast Milk Intake Scoring System.
Higher scores indicate greater breast milk intake.
Unit of
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Assessed at baseline (6-12 hours postpartum), immediately after the intervention, at 24, 48, and 72 hours postpartum, and on postpartum days 7 and 14.
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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
- KaratayU-RCT-WarmShower-2026
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Plánujete sdílet data jednotlivých účastníků (IPD)?
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