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NCT Number: NCT07612059

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured early postpartum mother-infant skin-to-skin contact

Behavioral

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 lavender aromatherapy

Other

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.

Primary outcomes

  1. Change in maternal salivary cortisol level

    Time frame: 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.

Secondary outcomes

  1. Maternal salivary IgA level

    Time frame: 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.

  2. State anxiety score (STAIS-5)

    Time frame: 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.

  3. Postoperative pain intensity (VAS)

    Time frame: 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.

  4. Postoperative nausea and vomiting

    Time frame: 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.

  5. Time to first analgesic requirement

    Time frame: 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.

  6. Early breastfeeding success

    Time frame: 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.

  7. LATCH breastfeeding score

    Time frame: 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).

  8. Neonatal axillary temperature

    Time frame: 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.

  9. Cumulative duration of skin-to-skin contact

    Time frame: 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.

  10. Need for mother-infant separation

    Time frame: 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).

  11. Correlation between skin-to-skin duration and cortisol change

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

aysenur dostbil, MD

CONTACT

[email protected]

+905333676696

orhan buyukkurt, MD

CONTACT

[email protected]

+905062883544

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Acronym: LAVENDER-SSC

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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