- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Istanbul
-
Istanbul, Istanbul, Turquie (Türkiye), 34010
- State Obstetrics and Gynecology Hospital, Istanbul
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Aucune intervention: Control: Routine Labor Care
Participants received routine intrapartum care without showering during labor.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Labor Pain Intensity
Délai: Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
|
Pain intensity assessed using the Visual Analog Scale (VAS) during labor.
|
Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anxiety Level During Labor
Délai: Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
|
Anxiety assessed using the Visual Analog Scale (VAS) during labor.
|
Every 2 hours during labor (up to 8 hours) and immediately before and after each shower session during the same labor admission.
|
|
Maternal Comfort During Labor
Délai: At 10 minutes after the first shower session during active labor
|
Maternal comfort assessed using the Childbirth Comfort Questionnaire.
|
At 10 minutes after the first shower session during active labor
|
|
Birth Satisfaction
Délai: 2 hours postpartum.
|
Birth satisfaction assessed using the Birth Satisfaction Scale.
|
2 hours postpartum.
|
|
Duration of Labor
Délai: From admission to the labor unit until delivery.
|
Total duration of labor measured in hours, obtained from clinical records.
|
From admission to the labor unit until delivery.
|
|
Mode of Delivery
Délai: At delivery.
|
Type of delivery (vaginal or cesarean) recorded from clinical records.
|
At delivery.
|
|
Use of Obstetric Interventions
Délai: During labor and recorded at delivery.
|
Use of obstetric interventions (e.g., induction, augmentation, episiotomy) recorded from clinical records.
|
During labor and recorded at delivery.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Showering During Labor
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .