- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: AYSENUR DOSTBİL, MD
- Telefonnummer: +905333676696
- E-mail: adostbil@hotmail.com
Undersøgelse Kontakt Backup
- Navn: orhan buyukkurt, MD
- Telefonnummer: +905062883544
- E-mail: orti_jordan@hotmail.com
Studiesteder
-
-
-
Erzurum, Tyrkiet (Türkiye), 25240
- Ataturk University
-
Kontakt:
- AYSENUR DOSTBİL, MD
- Telefonnummer: +905333676696
- E-mail: adostbil@hotmail.com
-
Kontakt:
- orhan buyukkurt, MD
- Telefonnummer: +905062883544
- E-mail: orti_jordan@hotmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: 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.
|
|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in maternal salivary cortisol level
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maternal salivary IgA level
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: kamber kasali, PhD, Atatürk University Faculty of Medicine, Department of Biostatistics, Erzurum, Turkey
- Studiestol: gamzenur cimilli senocak, MD, Atatürk University Faculty of Medicine, Department of Obstetrics and Gynecology, Erzurum, Turkey
- Studiestol: orhan buyukkurt, MD, Ataturk University Faculty of Medicine, Department of Anesthesiology and Reanimation
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B.30.2.ATA.0.01.00/229
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Kejsersnit
-
University Hospital, GrenobleIkke rekrutterer endnuPost-Cesarean Maternal Satisfaction Scale