- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07659249
USE OF PERINEAL MIRROR DURING THE SECOND STAGE OF LABOR
THE EFFECT OF PERİNEAL MİRROR USE DURİNG THE SECOND STAGE OF LABOR ON THE DURATİON OF THE SECOND STAGE, RECOVERY, AND PERCEİVED PAİN, SUPPORT, AND CONTROL LEVELS DURİNG DELİVERY
Objective: This study was designed to evaluate the effect of perineal mirror use during the second stage of labor on the duration of the second stage, postpartum recovery, and perceived pain, support, and control levels during delivery.
Method: The study was designed as a randomized controlled experimental study to examine the effect of perineal mirror use on delivery outcomes in primiparous women. The study population consisted of primiparous pregnant women admitted to the maternity clinic between June 29, 2026, and October 30, 2026. The sample size was calculated using the G*Power 3.1.9.2 program with an effect size of 0.50, 5% Type I error, and 95% power level; a total of 72 participants were selected, 36 in the intervention group and 36 in the control group. Considering potential losses, the sample size was increased by 10%, and a total of 80 pregnant women were planned to be included in the study. Participants were randomly assigned to the intervention group using a perineal mirror and the control group receiving routine care. The following instruments will be used as data collection tools: Pregnancy Demographic Information Form, REEDA Scale, Visual Analog Scale (VAS), and Perceived Support and Control in Childbirth Scale.
Expected Outcome: It is predicted that the perineal mirror may increase the woman's active participation, motivation, and perceived control by allowing her to see the fetal descent and the progress of labor; consequently, it may reduce the duration of active pushing and the duration of the second stage. It is also thought that it may have positive effects on the birth experience, postpartum recovery, and perceived level of support and control. The research results are expected to provide evidence for non-invasive and low-cost applications that can be used in childbirth care.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: MELEK BALÇIK ÇOLAK, MSc, Assoc. Prof.
- Telefonnummer: +90 264 295 3881
- E-post: mbalcikcolak@sakarya.edu.tr
Studiesteder
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Düzce, Tyrkia (Türkiye)
- Düzce Atatürk State Hospital
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Ta kontakt med:
- Nurşen BAYRAM AYBEY
- Telefonnummer: +90 534 692 7151
- E-post: nursen.bayram1@ogr.sakarya.edu.tr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Women aged 19 and over
- Women with term pregnancy (38+0 - 41+6)
- Women with singleton pregnancy
- Women who have had spontaneous vaginal delivery
- Primiparous pregnant women
- Women who voluntarily agree to participate in the study will be included.
Exclusion Criteria:
- Women with high-risk pregnancies
- Women with multiple pregnancies
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Perineal Mirror Group
Participants in this group will receive perineal mirror use during the active pushing phase of the second stage of labor in addition to routine intrapartum care.
The mirror will be positioned to allow visualization of fetal descent and birth progress.
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A perineal mirror will be positioned at the foot of the delivery bed during the active pushing phase of the second stage of labor.
The mirror will allow the woman to visualize fetal descent and birth progress while continuing routine intrapartum care.
The intervention is non-invasive, does not alter standard clinical management, and is intended to enhance maternal participation, motivation, perceived control, and support during childbirth.
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Ingen inngripen: Routine Care Group
Participants in this group will receive routine intrapartum care during labor without perineal mirror use.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Duration of the Second Stage of Labor
Tidsramme: During labor (second stage of labor)
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Duration of the second stage of labor, measured in minutes from complete cervical dilatation to birth.
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During labor (second stage of labor)
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- E-43012747-050.04-579687-319
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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