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Continuous Birth Support by Student Midwives and Labor Pain and Birth Satisfaction (MİDWİFERY)

29. april 2026 oppdatert av: Antalya Bilim University

The Effect of Continuous Birth Support Provided by Student Midwives on Labor Outcomes, Birth Perception, and Birth Satisfaction: A Randomized Controlled Trial

This randomized controlled study aimed to evaluate the effect of continuous birth support provided by senior student midwives on labor outcomes, birth perception, and birth satisfaction. Pregnant women admitted for spontaneous vaginal birth were randomly assigned to either a continuous birth support group or a routine care control group. The intervention consisted of continuous non-pharmacological support provided by trained student midwives under supervision throughout labor. Primary outcomes included perceived birth pain and birth satisfaction, while secondary outcomes included birth perception and obstetric interventions.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This randomized controlled trial is designed to evaluate the effect of continuous birth support provided by student midwives on labor pain intensity and birth satisfaction among women giving birth vaginally. The study will be conducted in a maternity hospital setting.

Eligible pregnant women who are admitted to the labor ward and meet the inclusion criteria will be informed about the study and asked to provide written informed consent before participation. After enrollment, participants will be randomly assigned to either an experimental group receiving continuous birth support or a control group receiving routine intrapartum care.

Participants in the experimental group will receive continuous birth support provided by trained student midwives in addition to routine intrapartum care. The intervention will consist of structured breathing exercises guided by student midwives, including slow-paced breathing, patterned breathing during contractions, and relaxation-focused breathing between contractions. The support will begin at admission to the labor ward and continue throughout labor until birth, following a standardized intervention protocol.

Participants in the control group will receive routine intrapartum care according to the standard clinical protocols of the maternity hospital, including regular maternal and fetal monitoring and clinical care by midwives and obstetric staff. No structured breathing exercise program will be provided.

The primary outcome of the study is labor pain intensity, assessed using the Visual Analog Scale (VAS). Pain will be measured at two time points: at admission to the labor ward (baseline) and at cervical dilatation of 6-7 cm.

The secondary outcome is birth satisfaction, assessed within 24 hours postpartum using the Birth Satisfaction Scale-Revised (BSS-R). he study aims to determine whether continuous birth support provided by student midwives is associated with reduced labor pain intensity and increased birth satisfaction compared to routine intrapartum care.

Studietype

Intervensjonell

Registrering (Faktiske)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia (Türkiye)
    • Döşemealti
      • Antalya, Döşemealti, Tyrkia (Türkiye), 07190
        • Antalya

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Pregnant women aged 18 years or older
  • Singleton pregnancy
  • Gestational age ≥ 37 completed weeks
  • Low-risk pregnancy
  • Planned vaginal birth
  • Admitted to the labor ward in the latent or early active phase of labor
  • No pharmacological analgesia before the first pain assessment
  • Ability to communicate and provide written informed consent

Exclusion Criteria:

  • High-risk pregnancy requiring continuous medical or obstetric intervention
  • Planned cesarean section
  • Multiple pregnancy
  • Known fetal anomaly
  • Use of pharmacological analgesia (e.g., epidural anesthesia, systemic opioids) before baseline pain assessment
  • Obstetric complications requiring emergency intervention at admission (e.g., fetal distress, placental abruption, cord prolapse)
  • Inability to cooperate with breathing exercises

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Continuous Birth Support by Student Midwives
Participants received continuous non-pharmacological birth support provided by trained senior student midwifery students under supervision throughout labor.
Atferdsmessig: Continuous Birth Support
Continuous emotional, physical, informational, and advocacy support provided by senior student midwifery students under supervision during labor, including positioning, breathing techniques, massage, relaxation techniques, and psychological support.
Annen: Routine Intrapartum Care
Participants received routine intrapartum care without continuous one-to-one birth support.
Annen: Routine Care
Standard intrapartum care practices routinely provided in the study setting.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in labor pain intensity from baseline to active labor.
Tidsramme: Baseline and during active labor, up to 24 hours
Labor pain intensity will be assessed using the Visual Analog Scale, a 10-centimeter horizontal line anchored with "no pain" and "worst pain imaginable." Scores range from 0 to 10. Higher scores indicate greater pain intensity. The outcome will be the change in participant-reported VAS score from baseline to active labor.
Baseline and during active labor, up to 24 hours
Birth satisfaction measured by the Birth Satisfaction Scale-Revised
Tidsramme: Up to 24 hours postpartum (Day 1)
Birth satisfaction will be assessed using the Birth Satisfaction Scale-Revised, a validated self-report questionnaire measuring women's satisfaction with the childbirth experience. The total score ranges from 0 to 40. Higher scores indicate greater birth satisfaction. The total scale score will be used as the outcome measure.
Up to 24 hours postpartum (Day 1)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Obstetric Interventions
Tidsramme: During active labor (cervical dilation 4-10 cm, assessed continuously until delivery and at 1 hour postpartum
Frequency of obstetric interventions during labor, including episiotomy, amniotomy, and labor augmentation.
During active labor (cervical dilation 4-10 cm, assessed continuously until delivery and at 1 hour postpartum

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Antalya Bilim University

Etterforskere

  • Hovedetterforsker: Seda Serhatlioglu, Doctorate, Antalya Bilim University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

  • Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database of Systematic Reviews. 2017;7:CD003766. doi:10.1002/14651858.CD003766.pub6
  • Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database of Systematic Reviews. 2013;7:CD003766. doi:10.1002/14651858.CD003766.pub5

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. desember 2024

Primær fullføring (Faktiske)

4. mars 2025

Studiet fullført (Faktiske)

4. mars 2025

Datoer for studieregistrering

Først innsendt

31. desember 2025

Først innsendt som oppfylte QC-kriteriene

29. april 2026

Først lagt ut (Faktiske)

4. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025-SS
  • 1919B012325051 (Annet stipend/finansieringsnummer: TUBITAK 2209-A Undergraduate Research Support Program)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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