An interventional study of Structured early postpartum mother-infant skin-to-skin contact and Maternal inhalational lavender aromatherapy in Breastfeeding, Cesarean Section and Postpartum Period, sponsored by Ataturk University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care
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.
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.
262 studies on the registry are indexed under Breast Feeding; 112 are open to participants now.
This study's planned enrollment of 150 is above the median of 95 across 210 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Behavioral: Structured early postpartum mother-infant skin-to-skin contact
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.
Behavioral: Structured early postpartum mother-infant skin-to-skin contact · Other: Maternal inhalational lavender aromatherapy
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.
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.
Time frame: From immediately after birth (T0) to 60 minutes postpartum (T1)
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.
Time frame: From immediately after birth (T0) to 60 minutes postpartum (T1)
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.
Time frame: Preoperative baseline to 120 minutes postpartum (T2)
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.
Time frame: 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.
Time frame: 60 minutes (T1) and 120 minutes (T2) postpartum
Time to first analgesic requirement
Time from completion of surgery to first request or administration of postoperative analgesia, recorded in minutes.
Time frame: From end of surgery to first analgesic requirement within the first 24 hours postoperatively
Early breastfeeding success
Proportion of mothers achieving successful breastfeeding within the first 60 and 120 minutes postpartum, as judged by effective latch and sustained feeding.
Time frame: Within 60 minutes and within 120 minutes postpartum
LATCH breastfeeding score
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).
Time frame: From first breastfeeding attempt up to 120 minutes postpartum (T2)
Neonatal axillary temperature
Neonatal axillary temperature measured with a digital thermometer at 60 minutes (T1) and 120 minutes (T2) postpartum.
Time frame: 60 minutes (T1) and 120 minutes (T2) postpartum
Cumulative duration of skin-to-skin contact
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.
Time frame: From birth to 60 minutes and to 120 minutes postpartum
Need for mother-infant separation
Requirement for temporary separation of mother and infant for clinical reasons during the first 2 hours postpartum (yes/no).
Time frame: Within the first 120 minutes postpartum
Correlation between skin-to-skin duration and cortisol change
Correlation between cumulative duration of skin-to-skin contact and change in maternal salivary cortisol level from T0 to T1.
Time frame: From immediately after birth (T0) to 60 minutes postpartum (T1)
Plan to share: No — There is no current plan to share individual participant data (IPD) outside the study team due to institutional and national data protection regulations.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ataturk University