- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07612059
Skin-to-Skin Contact and Lavender Aromatherapy After Elective Cesarean: Effects on Cortisol and Early Breastfeeding (LAVENDER-SSC)
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
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: AYSENUR DOSTBİL, MD
- Telefonszám: +905333676696
- E-mail: adostbil@hotmail.com
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: orhan buyukkurt, MD
- Telefonszám: +905062883544
- E-mail: orti_jordan@hotmail.com
Tanulmányi helyek
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Erzurum, Törökország (Türkiye), 25240
- Ataturk University
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Kapcsolatba lépni:
- AYSENUR DOSTBİL, MD
- Telefonszám: +905333676696
- E-mail: adostbil@hotmail.com
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Kapcsolatba lépni:
- orhan buyukkurt, MD
- Telefonszám: +905062883544
- E-mail: orti_jordan@hotmail.com
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
Egészséges önkénteseket fogad
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Nincs beavatkozás: 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.
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Kísérleti: 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.
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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.
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Kísérleti: 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.
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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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Change in maternal salivary cortisol level
Időkeret: From immediately after birth (T0) to 60 minutes postpartum (T1)
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Difference in maternal salivary cortisol concentration between immediately after birth (T0) and 60 minutes postpartum (T1), compared among the three study groups.
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From immediately after birth (T0) to 60 minutes postpartum (T1)
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Maternal salivary IgA level
Időkeret: From immediately after birth (T0) to 60 minutes postpartum (T1)
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Maternal salivary immunoglobulin A (IgA) concentrations measured immediately after birth (T0) and at 60 minutes postpartum (T1), compared among study groups.
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From immediately after birth (T0) to 60 minutes postpartum (T1)
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State anxiety score (STAIS-5)
Időkeret: Preoperative baseline to 120 minutes postpartum (T2)
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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.
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Preoperative baseline to 120 minutes postpartum (T2)
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Postoperative pain intensity (VAS)
Időkeret: 60 minutes (T1) and 120 minutes (T2) postpartum
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Maternal postoperative pain scores measured using a 0-10 cm visual analog scale (VAS) at 60 minutes (T1) and 120 minutes (T2) postpartum.
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60 minutes (T1) and 120 minutes (T2) postpartum
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Postoperative nausea and vomiting
Időkeret: 60 minutes (T1) and 120 minutes (T2) postpartum
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Presence and severity of postoperative nausea (0-3 scale) and the occurrence of vomiting recorded at 60 minutes (T1) and 120 minutes (T2) postpartum.
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60 minutes (T1) and 120 minutes (T2) postpartum
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Time to first analgesic requirement
Időkeret: From end of surgery to first analgesic requirement within the first 24 hours postoperatively
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Time from completion of surgery to first request or administration of postoperative analgesia, recorded in minutes.
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From end of surgery to first analgesic requirement within the first 24 hours postoperatively
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Early breastfeeding success
Időkeret: Within 60 minutes and within 120 minutes postpartum
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Proportion of mothers achieving successful breastfeeding within the first 60 and 120 minutes postpartum, as judged by effective latch and sustained feeding.
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Within 60 minutes and within 120 minutes postpartum
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LATCH breastfeeding score
Időkeret: From first breastfeeding attempt up to 120 minutes postpartum (T2)
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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).
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From first breastfeeding attempt up to 120 minutes postpartum (T2)
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Neonatal axillary temperature
Időkeret: 60 minutes (T1) and 120 minutes (T2) postpartum
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Neonatal axillary temperature measured with a digital thermometer at 60 minutes (T1) and 120 minutes (T2) postpartum.
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60 minutes (T1) and 120 minutes (T2) postpartum
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Cumulative duration of skin-to-skin contact
Időkeret: From birth to 60 minutes and to 120 minutes postpartum
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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.
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From birth to 60 minutes and to 120 minutes postpartum
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Need for mother-infant separation
Időkeret: Within the first 120 minutes postpartum
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Requirement for temporary separation of mother and infant for clinical reasons during the first 2 hours postpartum (yes/no).
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Within the first 120 minutes postpartum
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Correlation between skin-to-skin duration and cortisol change
Időkeret: From immediately after birth (T0) to 60 minutes postpartum (T1)
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Correlation between cumulative duration of skin-to-skin contact and change in maternal salivary cortisol level from T0 to T1.
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From immediately after birth (T0) to 60 minutes postpartum (T1)
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi szék: kamber kasali, PhD, Atatürk University Faculty of Medicine, Department of Biostatistics, Erzurum, Turkey
- Tanulmányi szék: gamzenur cimilli senocak, MD, Atatürk University Faculty of Medicine, Department of Obstetrics and Gynecology, Erzurum, Turkey
- Tanulmányi szék: orhan buyukkurt, MD, Ataturk University Faculty of Medicine, Department of Anesthesiology and Reanimation
Publikációk és hasznos linkek
Általános kiadványok
- 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.
- 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.
- 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.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- B.30.2.ATA.0.01.00/229
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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