- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07563374
Continuous Birth Support by Student Midwives and Labor Pain and Birth Satisfaction (MİDWİFERY)
The Effect of Continuous Birth Support Provided by Student Midwives on Labor Outcomes, Birth Perception, and Birth Satisfaction: A Randomized Controlled Trial
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Döşemealti
-
Antalya, Döşemealti, Turkki (Türkiye), 07190
- Antalya
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Continuous Birth Support by Student Midwives
Participants received continuous non-pharmacological birth support provided by trained senior student midwifery students under supervision throughout labor.
|
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.
|
|
Muut: Routine Intrapartum Care
Participants received routine intrapartum care without continuous one-to-one birth support.
|
Standard intrapartum care practices routinely provided in the study setting.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in labor pain intensity from baseline to active labor.
Aikaikkuna: 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
Aikaikkuna: 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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Obstetric Interventions
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Seda Serhatlioglu, Doctorate, Antalya Bilim University
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2025-SS
- 1919B012325051 (Muu apuraha/rahoitusnumero: TUBITAK 2209-A Undergraduate Research Support Program)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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