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BreastfeedingLAVENDER-SSCNCT07612059

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

A study testing Structured early postpartum mother-infant skin-to-skin contact and Maternal inhalational lavender aromatherapy in people with Breastfeeding and Cesarean Section, run by Ataturk University at 1 site in Turkey (Türkiye).

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breastfeeding, Cesarean Section, Postpartum Period
What is being tested?
Structured early postpartum mother-infant skin-to-skin contact and Maternal inhalational lavender aromatherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2026to 30 Dec 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

aysenur dostbil, MD contact

+905333676696

adostbil@hotmail.com

orhan buyukkurt, MD contact

+905062883544

orti_jordan@hotmail.com

Turkey (Türkiye)1 site
  • Ataturk University

    Erzurum, 25240

    AYSENUR DOSTBİL, MD, +905333676696, adostbil@hotmail.com

    orhan buyukkurt, MD, +905062883544, orti_jordan@hotmail.com

Other trials in Turkey (Türkiye)

About this study

Official 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

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.

Read the detailed description

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.

Being tested
Structured early postpartum mother-infant skin-to-skin contact, Maternal inhalational lavender aromatherapy
Keywords
Elective cesarean section, Skin-to-skin contact, Lavender aromatherapy, Salivary cortisol, Immunoglobulin A (IgA), Early breastfeeding, Postoperative pain
Medical subject headings
Breast Feeding, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured early postpartum mother-infant skin-to-skin contactBehavioural

    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 aromatherapyOther

    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.

Study groups in NCT07612059
Study groupRoleWhat they receive
Routine CareNo interventionParticipants 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.
Structured Skin-to-Skin ContactExperimentalParticipants 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.
Receives: Behavioral: Structured early postpartum mother-infant skin-to-skin contact
Structured Skin-to-Skin Contact Plus Lavender AromatherapyExperimentalParticipants 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.
Receives: Behavioral: Structured early postpartum mother-infant skin-to-skin contact; Other: Maternal inhalational lavender aromatherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From immediately after birth (T0) to 60 minutes postpartum (T1)

Secondary outcomes (11)
  1. 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.

    Measured: From immediately after birth (T0) to 60 minutes postpartum (T1)

  2. 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.

    Measured: Preoperative baseline to 120 minutes postpartum (T2)

  3. 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.

    Measured: 60 minutes (T1) and 120 minutes (T2) postpartum

  4. 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.

    Measured: 60 minutes (T1) and 120 minutes (T2) postpartum

  5. Time to first analgesic requirement

    Time from completion of surgery to first request or administration of postoperative analgesia, recorded in minutes.

    Measured: From end of surgery to first analgesic requirement within the first 24 hours postoperatively

  6. 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.

    Measured: Within 60 minutes and within 120 minutes postpartum

  7. 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).

    Measured: From first breastfeeding attempt up to 120 minutes postpartum (T2)

  8. Neonatal axillary temperature

    Neonatal axillary temperature measured with a digital thermometer at 60 minutes (T1) and 120 minutes (T2) postpartum.

    Measured: 60 minutes (T1) and 120 minutes (T2) postpartum

  9. 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.

    Measured: From birth to 60 minutes and to 120 minutes postpartum

  10. Need for mother-infant separation

    Requirement for temporary separation of mother and infant for clinical reasons during the first 2 hours postpartum (yes/no).

    Measured: Within the first 120 minutes postpartum

  11. 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.

    Measured: From immediately after birth (T0) to 60 minutes postpartum (T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment of three groups: routine postoperative care, structured early postpartum mother-infant skin-to-skin contact, and structured skin-to-skin contact combined with maternal inhalational lavender aromatherapy after elective cesarean section under spinal anesthesia.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07612059
Sponsor's protocol ID
B.30.2.ATA.0.01.00/229
Acronym
LAVENDER-SSC
Status last verified
May 2026
First submitted
21 May 2026
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no current plan to share individual participant data (IPD) outside the study team due to institutional and national data protection regulations.

Publications

  • Namba Y, Smith JB, Fox GS, Challis JR. Plasma cortisol concentrations during Caesarean section. Br J Anaesth. 1980 Oct;52(10):1027-32. doi: 10.1093/bja/52.10.1027.

    PubMed 7437211
  • Nouira M, Souayeh N, Kanzari SA, Rouis H, Lika A, Mbarki C, Rahali FZ, Bettaieb H. Aromatherapy Using Lavender Oil Effectiveness on Pain and Anxiety After C-Section: A Randomized Controlled Trial. J Epidemiol Glob Health. 2024 Dec;14(4):1536-1544. doi: 10.1007/s44197-024-00305-6. Epub 2024 Oct 14.

    PubMed 39400653
  • Widstrom AM, Brimdyr K, Svensson K, Cadwell K, Nissen E. Skin-to-skin contact the first hour after birth, underlying implications and clinical practice. Acta Paediatr. 2019 Jul;108(7):1192-1204. doi: 10.1111/apa.14754. Epub 2019 Mar 13.

    PubMed 30762247

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