- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07831785
Supportive Care During Childbirth in Syrian Migrant Women
Comparison of Childbirth Satisfaction, Breastfeeding Self-Efficacy, and Perceived Stress in Syrian Migrant Women Receiving and Not Receiving Supportive Care During Childbirth
This randomized controlled trial aims to evaluate the effects of structured supportive midwifery care provided during labor on childbirth satisfaction, breastfeeding success, breastfeeding self-efficacy, and perceived stress among Syrian migrant women. A total of 100 eligible women admitted to the delivery unit of Yuregir State Hospital in Adana, Türkiye, will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Women in the intervention group will receive structured supportive midwifery care in addition to routine hospital care, whereas women in the control group will receive routine maternity care. The supportive care intervention will include physical support, emotional support, informational and communication support, and advocacy throughout labor. Outcomes will be assessed using validated measurement tools during the childbirth and early postpartum periods.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This study is designed as a two-arm, parallel-group, randomized controlled trial. The study population will consist of Syrian migrant women admitted in active labor to the Delivery Unit of Yuregir State Hospital in Adana, Türkiye, who meet the eligibility criteria and provide written informed consent.
A total of 100 participants will be randomized in a 1:1 ratio to the intervention group (n=50) or control group (n=50). A variable block randomization procedure using block sizes of 4 and 6 will be used. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes.
Participants assigned to the intervention group will receive structured supportive midwifery care provided by the researcher midwife throughout labor in addition to routine hospital care. The intervention consists of four main components: physical support, emotional support, informational and communication support, and advocacy. Physical support includes measures such as mobilization, position changes, breathing and relaxation techniques, massage, sacral pressure, touch, and other comfort measures according to the woman's needs. Emotional support includes continuous presence, reassurance, encouragement, empathetic communication, and respect for privacy. Informational support includes explanations about the labor process, procedures, breathing and pushing techniques, and early postpartum and breastfeeding education. Advocacy focuses on supporting women's preferences, participation in decision-making, privacy, and communication with healthcare professionals.
Participants assigned to the control group will receive the routine labor and postpartum care provided by the hospital without the additional structured supportive care intervention delivered by the researcher.
Study outcomes include childbirth satisfaction, breastfeeding success assessed using the LATCH Breastfeeding Assessment Tool, postpartum breastfeeding self-efficacy, and perceived stress. Data will be collected at predefined time points from the beginning of labor through the first 24 hours postpartum.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Özlem KOÇ, PhD
- Telefoonnummer: 05520839594
- E-mail: ozlemkoc@tarsus.edu.tr
Studie Locaties
-
-
-
Adana, Turkije (Türkiye)
- Adana Yuregir State Hospital
-
Contact:
- Fatma KEÇE
- Telefoonnummer: +90 05347857596
- E-mail: 254131005@tarsus.edu.tr
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Syrian migrant women admitted to the Delivery Unit of Adana Yüreğir State Hospital due to labor.
- Aged 18 years or older.
- Gestational age between 37 and 42 weeks.
- Singleton, live pregnancy.
- Fetus in cephalic presentation.
- Spontaneous vaginal labor initiated and in the active phase of labor.
- Able to communicate in Arabic or Turkish at a level sufficient to understand the data collection instruments and the intervention to be applied.
- Voluntarily agreeing to participate in the study and providing informed consent.
Exclusion Criteria:
- Having a planned (elective) cesarean delivery decision at the time of admission.
- Having an obstetric condition contraindicating vaginal delivery.
- Having a high-risk pregnancy or labor condition, including severe preeclampsia, eclampsia, placenta previa, or placental abruption.
- Multiple pregnancy.
- Intrauterine fetal death or a major fetal anomaly incompatible with life.
- Having a maternal or fetal clinical condition requiring emergency obstetric intervention at the time of admission for labor.
- Having a cognitive impairment or severe psychiatric condition that would prevent participation, communication, or the informed consent process.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Structured Supportive Midwifery Care
Participants assigned to this arm will receive structured supportive midwifery care provided by the researcher midwife throughout labor in addition to routine hospital care. Supportive care includes physical support, emotional support, informational and communication support, and advocacy. |
Structured supportive midwifery care will be provided by the researcher midwife throughout labor in addition to routine hospital care. The intervention consists of four components: physical support, emotional support, informational and communication support, and advocacy. Physical support includes mobilization, position changes, breathing and relaxation techniques, massage, sacral pressure, touch, and comfort measures according to the woman's needs. Emotional support includes continuous presence, reassurance, encouragement, empathetic communication, and respect for privacy. Informational and communication support includes explanations about the labor process and procedures, guidance on breathing and pushing techniques, and early postpartum and breastfeeding education. Advocacy includes supporting the woman's preferences, participation in decision-making, privacy, and communication with healthcare professionals. |
|
Actieve vergelijker: Routine Care
Participants assigned to this arm will receive the routine labor and postpartum care provided by Yuregir State Hospital. No additional structured supportive midwifery care will be provided by the researcher. |
Structured supportive midwifery care will be provided by the researcher midwife throughout labor in addition to routine hospital care. The intervention consists of four components: physical support, emotional support, informational and communication support, and advocacy. Physical support includes mobilization, position changes, breathing and relaxation techniques, massage, sacral pressure, touch, and comfort measures according to the woman's needs. Emotional support includes continuous presence, reassurance, encouragement, empathetic communication, and respect for privacy. Informational and communication support includes explanations about the labor process and procedures, guidance on breathing and pushing techniques, and early postpartum and breastfeeding education. Advocacy includes supporting the woman's preferences, participation in decision-making, privacy, and communication with healthcare professionals. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Childbirth Satisfaction
Tijdsspanne: At 24 hours postpartum
|
Childbirth satisfaction will be assessed using the Mackey Childbirth Satisfaction Rating Scale (MCSRS). The scale consists of 34 items rated on a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). The total score ranges from 34 to 170, with higher scores indicating greater satisfaction with the childbirth experience. |
At 24 hours postpartum
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Özlem KOÇ, Tarsus University, Faculty of Health Sciences, Department of Midwifery
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- FKECE-RCT-2026-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Individual participant data will not be shared.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .