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Skin-to-Skin Contact and Lavender Aromatherapy After Elective Cesarean: Effects on Cortisol and Early Breastfeeding (LAVENDER-SSC)

21 de mayo de 2026 actualizado por: Aysenur Dostbil, Ataturk University

Elective Cesarean Section Postpartum Structured Mother-Infant Skin-to-Skin Contact With Maternal Lavender Aromatherapy: Effects on Maternal Salivary Cortisol, IgA Levels and Early Breastfeeding Outcomes - A Randomized Controlled Trial

This single-center randomized controlled clinical trial will evaluate the effects of structured early postpartum mother-infant skin-to-skin contact, with or without maternal lavender aromatherapy, after elective cesarean section on maternal stress biomarkers and early breastfeeding outcomes. The study will enroll 150 term pregnant women scheduled for elective cesarean section under spinal anesthesia at Ataturk University Research Hospital. Participants will be randomized into three groups: routine postoperative care, structured skin-to-skin contact, and structured skin-to-skin contact combined with inhalational lavender aromatherapy. The primary outcome is the change in maternal salivary cortisol level from immediately after birth to 60 minutes postpartum. Secondary outcomes include maternal salivary IgA levels, state anxiety scores, postoperative pain and nausea, time to first analgesic requirement, early breastfeeding initiation and success, LATCH scores, neonatal axillary temperature, cumulative duration and continuity of skin-to-skin contact, maternal satisfaction, and the need for mother-infant separation within the first 2 hours postpartum.

Descripción general del estudio

Descripción detallada

Cesarean section rates are increasing worldwide, and optimizing maternal and neonatal outcomes in the early postpartum period has become a clinical priority. Elective cesarean delivery is associated with surgical and anesthetic stress, altered hypothalamic-pituitary-adrenal axis activation, and delayed mother-infant interaction, which may negatively affect bonding and breastfeeding. Early skin-to-skin contact between mother and newborn is an evidence-based physiological intervention that promotes thermal stability, attenuates stress responses, and supports breastfeeding, but its hormonal and biochemical mechanisms after elective cesarean section have not been fully elucidated. Lavender aromatherapy is a non-pharmacological method that has been reported to reduce perioperative anxiety and pain in cesarean mothers; however, its combined use with structured skin-to-skin contact in the early postpartum period has not been previously investigated in a randomized controlled design.

This prospective, randomized, controlled, three-arm interventional study will be conducted in the Obstetrics and Gynecology Clinic of Ataturk University Faculty of Medicine Research Hospital. A total of 150 volunteer pregnant women aged 18-40 years with term singleton pregnancies scheduled for elective cesarean section under spinal anesthesia and classified as ASA physical status I-II will be included. Participants will be randomized in equal numbers (n=50 per group) to: Group 1, routine postoperative care; Group 2, structured early postpartum mother-infant skin-to-skin contact; and Group 3, structured skin-to-skin contact plus maternal inhalational lavender aromatherapy. All interventions will be delivered by anesthesiology investigators trained in the study protocol. Salivary samples for cortisol and IgA will be collected immediately after birth (T0) and at 60 minutes postpartum (T1). State anxiety (STAIS-5), postoperative pain (VAS), nausea-vomiting, time to first analgesic requirement, breastfeeding initiation time, breastfeeding success within the first 60 and 120 minutes, LATCH scores, neonatal axillary temperature, cumulative duration and interruptions of skin-to-skin contact, the need for mother-infant separation, and maternal satisfaction at 120 minutes (T2) will be systematically recorded using predefined case report forms.

Routine intraoperative and postoperative monitoring and care will be maintained for all participants, and no additional invasive procedures or pharmacological agents beyond standard practice will be introduced. Statistical analyses will be performed using IBM SPSS Statistics v26.0. Continuous variables will be summarized as mean and standard deviation or median and interquartile range as appropriate, and categorical variables as counts and percentages. Between-group comparisons will use one-way ANOVA or Kruskal-Wallis tests for continuous variables and chi-square or Fisher's exact tests for categorical variables. Changes in cortisol over time will be analyzed with repeated-measures methods, and the relationship between cumulative skin-to-skin duration and cortisol change will be assessed using Pearson or Spearman correlation coefficients. All comparisons will be reported with 95 confidence intervals, with a two-sided p value less than 0.05 considered statistically significant.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

150

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: AYSENUR DOSTBİL, MD
  • Número de teléfono: +905333676696
  • Correo electrónico: adostbil@hotmail.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Female participants aged 18 to 40 years
  • Term singleton pregnancy (≥37 weeks of gestation)
  • Scheduled for elective cesarean section
  • ASA physical status I-II
  • Planned spinal anesthesia
  • Clinically stable mother and newborn immediately after birth
  • Ability to initiate breastfeeding in the early postpartum period
  • Provision of written informed consent

Exclusion Criteria:

  • Emergency cesarean section
  • General anesthesia or conversion from spinal to general anesthesia
  • Need for neonatal resuscitation or severe neonatal compromise
  • Maternal hemodynamic instability or massive hemorrhage
  • Major fetal congenital anomalies
  • Known allergy or intolerance to lavender
  • Severe asthma or intolerance to strong odors
  • Major psychiatric disorders
  • Serious endocrine diseases affecting stress hormone regulation
  • Clinical conditions that preclude breastfeeding
  • Contraindications to spinal anesthesia
  • Refusal to participate in the study

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Routine Care
Participants in this arm will receive routine intraoperative and postoperative care after elective cesarean section under spinal anesthesia, according to the standard practice of Ataturk University Research Hospital. No structured early skin-to-skin contact protocol or lavender aromatherapy will be applied beyond usual care.
Experimental: Structured Skin-to-Skin Contact
Participants in this arm will receive a structured early postpartum mother-infant skin-to-skin contact protocol after elective cesarean section under spinal anesthesia. Following delivery and clinical stabilization of the mother and newborn, the naked neonate will be placed prone on the mother's bare chest, covered with a warm blanket, and maintained in continuous skin-to-skin contact during the first 60 minutes postpartum as tolerated. Cumulative duration of skin-to-skin contact, number of interruptions, and reasons for interruption will be recorded.
A structured early postpartum skin-to-skin contact protocol applied after elective cesarean section under spinal anesthesia. Following stabilization of the mother and newborn, the naked neonate is placed prone on the mother's bare chest and covered with a warm blanket. Continuous skin-to-skin contact is maintained during the first 60 minutes postpartum as tolerated, and cumulative duration, number of interruptions, and reasons for interruption are recorded.
Experimental: Structured Skin-to-Skin Contact Plus Lavender Aromatherapy
Participants in this arm will receive the same structured early postpartum mother-infant skin-to-skin contact protocol as in the skin-to-skin only group, combined with maternal inhalational lavender aromatherapy. Lavender essential oil will be administered via inhalation using a cotton pad or similar carrier placed near the mother's face during the early postpartum period, starting shortly after surgery and maintained during the first 60 minutes postpartum as tolerated, according to the study protocol. Tolerance to aromatherapy and any adverse reactions will be monitored and recorded.
A structured early postpartum skin-to-skin contact protocol applied after elective cesarean section under spinal anesthesia. Following stabilization of the mother and newborn, the naked neonate is placed prone on the mother's bare chest and covered with a warm blanket. Continuous skin-to-skin contact is maintained during the first 60 minutes postpartum as tolerated, and cumulative duration, number of interruptions, and reasons for interruption are recorded.
Maternal inhalational aromatherapy using lavender essential oil during the early postpartum period after elective cesarean section. Lavender oil is applied via inhalation using a cotton pad or similar carrier placed near the mother's face during the first 60 minutes postpartum, in combination with the structured skin-to-skin contact protocol, as tolerated. Tolerance to aromatherapy and any adverse reactions are monitored and recorded.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in maternal salivary cortisol level
Periodo de tiempo: From immediately after birth (T0) to 60 minutes postpartum (T1)
Difference in maternal salivary cortisol concentration between immediately after birth (T0) and 60 minutes postpartum (T1), compared among the three study groups.
From immediately after birth (T0) to 60 minutes postpartum (T1)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Maternal salivary IgA level
Periodo de tiempo: From immediately after birth (T0) to 60 minutes postpartum (T1)
Maternal salivary immunoglobulin A (IgA) concentrations measured immediately after birth (T0) and at 60 minutes postpartum (T1), compared among study groups.
From immediately after birth (T0) to 60 minutes postpartum (T1)
State anxiety score (STAIS-5)
Periodo de tiempo: Preoperative baseline to 120 minutes postpartum (T2)
Change in maternal state anxiety assessed using the 5-item State-Trait Anxiety Inventory short form (STAIS-5) at preoperative baseline, 60 minutes (T1), and 120 minutes (T2) postpartum.
Preoperative baseline to 120 minutes postpartum (T2)
Postoperative pain intensity (VAS)
Periodo de tiempo: 60 minutes (T1) and 120 minutes (T2) postpartum
Maternal postoperative pain scores measured using a 0-10 cm visual analog scale (VAS) at 60 minutes (T1) and 120 minutes (T2) postpartum.
60 minutes (T1) and 120 minutes (T2) postpartum
Postoperative nausea and vomiting
Periodo de tiempo: 60 minutes (T1) and 120 minutes (T2) postpartum
Presence and severity of postoperative nausea (0-3 scale) and the occurrence of vomiting recorded at 60 minutes (T1) and 120 minutes (T2) postpartum.
60 minutes (T1) and 120 minutes (T2) postpartum
Time to first analgesic requirement
Periodo de tiempo: From end of surgery to first analgesic requirement within the first 24 hours postoperatively
Time from completion of surgery to first request or administration of postoperative analgesia, recorded in minutes.
From end of surgery to first analgesic requirement within the first 24 hours postoperatively
Early breastfeeding success
Periodo de tiempo: Within 60 minutes and within 120 minutes postpartum
Proportion of mothers achieving successful breastfeeding within the first 60 and 120 minutes postpartum, as judged by effective latch and sustained feeding.
Within 60 minutes and within 120 minutes postpartum
LATCH breastfeeding score
Periodo de tiempo: From first breastfeeding attempt up to 120 minutes postpartum (T2)
Breastfeeding performance assessed using the LATCH scoring system (total score 0-10) during the first successful breastfeeding attempt and, if needed, repeated at 120 minutes postpartum (T2).
From first breastfeeding attempt up to 120 minutes postpartum (T2)
Neonatal axillary temperature
Periodo de tiempo: 60 minutes (T1) and 120 minutes (T2) postpartum
Neonatal axillary temperature measured with a digital thermometer at 60 minutes (T1) and 120 minutes (T2) postpartum.
60 minutes (T1) and 120 minutes (T2) postpartum
Cumulative duration of skin-to-skin contact
Periodo de tiempo: From birth to 60 minutes and to 120 minutes postpartum
Total cumulative duration (in minutes) of mother-infant skin-to-skin contact during the first 60 and 120 minutes postpartum, including number and reasons for interruptions.
From birth to 60 minutes and to 120 minutes postpartum
Need for mother-infant separation
Periodo de tiempo: Within the first 120 minutes postpartum
Requirement for temporary separation of mother and infant for clinical reasons during the first 2 hours postpartum (yes/no).
Within the first 120 minutes postpartum
Correlation between skin-to-skin duration and cortisol change
Periodo de tiempo: From immediately after birth (T0) to 60 minutes postpartum (T1)
Correlation between cumulative duration of skin-to-skin contact and change in maternal salivary cortisol level from T0 to T1.
From immediately after birth (T0) to 60 minutes postpartum (T1)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Silla de estudio: kamber kasali, PhD, Atatürk University Faculty of Medicine, Department of Biostatistics, Erzurum, Turkey
  • Silla de estudio: gamzenur cimilli senocak, MD, Atatürk University Faculty of Medicine, Department of Obstetrics and Gynecology, Erzurum, Turkey
  • Silla de estudio: orhan buyukkurt, MD, Ataturk University Faculty of Medicine, Department of Anesthesiology and Reanimation

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de junio de 2026

Finalización del estudio (Estimado)

30 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

21 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de mayo de 2026

Publicado por primera vez (Actual)

28 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

There is no current plan to share individual participant data (IPD) outside the study team due to institutional and national data protection regulations.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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