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

NCT07612059 | Not Yet Recruiting

• 1 other identifier: B.30.2.ATA.0.01.00/229
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breastfeeding; Cesarean Section; Postpartum Period; Maternal Stress

Keywords

Elective cesarean section; Skin-to-skin contact; Lavender aromatherapy; Salivary cortisol; Immunoglobulin A (IgA); Early breastfeeding; Postoperative pain

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (11)

• Maternal salivary IgA level

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

• State anxiety score (STAIS-5)

  Preoperative baseline to 120 minutes postpartum (T2)

• Postoperative pain intensity (VAS)

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

• Postoperative nausea and vomiting

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

• Time to first analgesic requirement

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

Study Arms (3)

Routine Care

NO INTERVENTION

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.

Structured Skin-to-Skin Contact

EXPERIMENTAL

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

Structured Skin-to-Skin Contact Plus Lavender Aromatherapy

EXPERIMENTAL

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

Interventions

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.

Structured Skin-to-Skin Contact; Structured Skin-to-Skin Contact Plus Lavender Aromatherapy

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.

Structured Skin-to-Skin Contact Plus Lavender Aromatherapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 7437211 RESULT

• 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.

  PMID: 39400653 RESULT

• 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.

  PMID: 30762247 RESULT

MeSH Terms

Conditions

Breast Feeding; Pain, Postoperative

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• kamber kasali, PhD

  Atatürk University Faculty of Medicine, Department of Biostatistics, Erzurum, Turkey

  STUDY CHAIR

• gamzenur cimilli senocak, MD

  Atatürk University Faculty of Medicine, Department of Obstetrics and Gynecology, Erzurum, Turkey

  STUDY CHAIR

• orhan buyukkurt, MD

  Ataturk University Faculty of Medicine, Department of Anesthesiology and Reanimation

  STUDY CHAIR

Central Study Contacts

aysenur dostbil, MD

CONTACT

+905333676696; adostbil@hotmail.com

orhan buyukkurt, MD

CONTACT

+905062883544; orti_jordan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Open-label to participants and care providers; laboratory personnel and statistical analysis team will be blinded to group allocation when assessing biochemical and outcome data (outcomes assessor-masked).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology and Reanimation

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)