About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female participants aged 18 to 40 years
Term singleton pregnancy (≥37 weeks of gestation)
Scheduled for elective cesarean section
ASA physical status I-II
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Structured early postpartum mother-infant skin-to-skin contact
BehavioralA 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 lavender aromatherapy
Other interventionMaternal 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in maternal salivary cortisol level
Difference in maternal salivary cortisol concentration between immediately after birth (T0) and 60 minutes postpartum (T1), compared among the three study groups.
Secondary outcomes
Maternal salivary IgA level
Maternal salivary immunoglobulin A (IgA) concentrations measured immediately after birth (T0) and at 60 minutes postpartum (T1), compared among study groups.
State anxiety score (STAIS-5)
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.
Postoperative pain intensity (VAS)
Maternal postoperative pain scores measured using a 0-10 cm visual analog scale (VAS) at 60 minutes (T1) and 120 minutes (T2) postpartum.
Postoperative nausea and vomiting
Presence and severity of postoperative nausea (0-3 scale) and the occurrence of vomiting recorded at 60 minutes (T1) and 120 minutes (T2) postpartum.
Sponsors and contacts
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