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Supportive Care During Childbirth in Syrian Migrant Women

21. September 2026 aktualisiert von: Özlem KOÇ, Tarsus University

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.

Aktiver Komparator: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Childbirth Satisfaction
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Özlem KOÇ, Tarsus University, Faculty of Health Sciences, Department of Midwifery

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. März 2027

Studienabschluss (Geschätzt)

1. März 2027

Studienanmeldedaten

Zuerst eingereicht

15. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. September 2026

Zuerst gepostet (Tatsächlich)

21. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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