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

2026年5月21日 更新者:Aysenur Dostbil、Ataturk University

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

150

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
介入なし:Routine Care
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.
実験的:Structured Skin-to-Skin Contact
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.
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.
実験的:Structured Skin-to-Skin Contact Plus Lavender Aromatherapy
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.
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in maternal salivary cortisol level
時間枠: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.
From immediately after birth (T0) to 60 minutes postpartum (T1)

二次結果の測定

結果測定
メジャーの説明
時間枠
Maternal salivary IgA level
時間枠: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.
From immediately after birth (T0) to 60 minutes postpartum (T1)
State anxiety score (STAIS-5)
時間枠: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.
Preoperative baseline to 120 minutes postpartum (T2)
Postoperative pain intensity (VAS)
時間枠: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.
60 minutes (T1) and 120 minutes (T2) postpartum
Postoperative nausea and vomiting
時間枠: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.
60 minutes (T1) and 120 minutes (T2) postpartum
Time to first analgesic requirement
時間枠: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.
From end of surgery to first analgesic requirement within the first 24 hours postoperatively
Early breastfeeding success
時間枠: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.
Within 60 minutes and within 120 minutes postpartum
LATCH breastfeeding score
時間枠: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).
From first breastfeeding attempt up to 120 minutes postpartum (T2)
Neonatal axillary temperature
時間枠: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.
60 minutes (T1) and 120 minutes (T2) postpartum
Cumulative duration of skin-to-skin contact
時間枠: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.
From birth to 60 minutes and to 120 minutes postpartum
Need for mother-infant separation
時間枠: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).
Within the first 120 minutes postpartum
Correlation between skin-to-skin duration and cortisol change
時間枠: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.
From immediately after birth (T0) to 60 minutes postpartum (T1)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディチェア:kamber kasali, PhD、Atatürk University Faculty of Medicine, Department of Biostatistics, Erzurum, Turkey
  • スタディチェア:gamzenur cimilli senocak, MD、Atatürk University Faculty of Medicine, Department of Obstetrics and Gynecology, Erzurum, Turkey
  • スタディチェア:orhan buyukkurt, MD、Ataturk University Faculty of Medicine, Department of Anesthesiology and Reanimation

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2026年6月1日

研究の完了 (推定)

2027年12月30日

試験登録日

最初に提出

2026年5月21日

QC基準を満たした最初の提出物

2026年5月21日

最初の投稿 (実際)

2026年5月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月28日

QC基準を満たした最後の更新が送信されました

2026年5月21日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

There is no current plan to share individual participant data (IPD) outside the study team due to institutional and national data protection regulations.

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