- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Istanbul
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Istanbul, Istanbul, Turchia (Türkiye), 34010
- State Obstetrics and Gynecology Hospital, Istanbul
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Nessun intervento: Control: Routine Labor Care
Participants received routine intrapartum care without showering during labor.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Labor Pain Intensity
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Anxiety Level During Labor
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- Showering During Labor
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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