- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04827797
Effects of Different Birthing Balls Used at the First Stage of Childbirth
Effects of Different Birthing Balls Used at the First Stage of Childbirth on Birth Outcomes and Maternal Satisfaction November, 2018
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The study aimed to determine the effects of different birthing balls used at the first stage of childbirth on birth outcomes and maternal satisfaction. Randomized controlled, single-blind clinical study included a total of 180 pregnant women. The study included 3 groups (A: routine hospital care, B: spherical birthing ball, C: peanut ball). Especially spherical birthing ball, were effective in reducing labor pain and facilitating faster rate of descent of the fetal head, and they increased maternal satisfaction.
IMPACT STATEMENT What is already known on this subject? Labor pain and outcomes occurring during labor are known and expected situation. Some non-pharmacological methods are applied to ensure that birth is easy and maternal satisfaction is high.
What the results of this study add? There is no studies using the peanut ball and the spherical birth ball together. In our study, it was found that both balls are effective, but the spherical birth ball is more significant.
What the implications are of these findings for clinical practice and/or further research? Our study suggested that the spherical birth ball had effective on birth outcomes. Future studies should be performed to investigate the effects of birth balls in the postpartum period, breastfeeding or prenatal period.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Mersin
-
Toroslar, Mersin, Tyrkia
- Tuğçe Sönmez
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- primiparous
- admitted to the delivery room for vaginal delivery
- 38-40 week
- being in the latent phase of labor
- having no obstetric risks
Exclusion Criteria:
- undergo caesarean sections for various reasons
- having obstetric risks
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: birth ball
The positions and movements for birth ball in the active and latent phases: kneeling on the ground and leaning on the spherical birthing ball, sitting on the ball with front support, sitting positions on the spherical birthing ball, full rotation of hip, moving to the right/left, back and forth.
Positions and movements were repeated every 30 minutes.
The 30-minute intervals were interrupted in cases where the women were not feeling well.
|
Birth balls to exercise
Andre navn:
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|
Eksperimentell: peanut ball
The positions and movements for the pregnant women in peanut ball: upright sitting position, forward bending positions, with backward and forward movement and swaying right and left on the peanut ball
|
Birth balls to exercise
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Introductory Information Form
Tidsramme: when pregnant women come to the delivery room
|
this form consists of 7 questions regarding participants' descriptive and obstetric characteristics.
|
when pregnant women come to the delivery room
|
|
Visual Analogue Scale
Tidsramme: Latent, active and transition phase in labor
|
in this scale, the participants marked the severity of their pain on a 10-cm ruler with one end stating "no pain" and the other end "worst possible pain".
VAS was used to determine the severity of pain and the effectiveness of the intervention in this study.
|
Latent, active and transition phase in labor
|
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Verbal Rating Scale
Tidsramme: Latent, active and transition phase of labor
|
This scale is based on participants' choice of word that defines their pain state
|
Latent, active and transition phase of labor
|
|
Partogram
Tidsramme: active phase of labor
|
This is used starting from the active phase of labor.
The progress of the labor and the health status of the baby are monitored on the partogram
|
active phase of labor
|
|
Evaluation Scale for Maternal Satisfaction with Normal Delivery
Tidsramme: within a period of 1-4 hours postpartum
|
This is used to assess maternal satisfaction in normal delivery.
Higher total scores on the scale indicate stronger maternal satisfaction with the hospital care provided in normal delivery
|
within a period of 1-4 hours postpartum
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: tuğçe sönmez, Gaziantep ıslamic science and tecnology university
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
- 3301cukurova
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