CompletedNot Applicable

Peanut Ball in Labor to Reduce Anxiety and Pain

Honduras163 participantsStarted 2025-02-01

Plain-language summary

An open clinical trial-type study of randomized assignment groups, an interventional model of parallel assignment, will be carried out to establish whether or not there are significant differences in the levels of anxiety and intensity of pain, in labor in patients who use the peanut ball and those that don't.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Submission of a signed and dated informed consent form. * Declared willingness to comply with all study procedures and availability for the duration of the study. * Female 18 to 45 years of age * USG having normal amniotic fluid index and monitoring. * Gestational age \> 36 weeks 0 days * Singleton pregnancy * Cephalic presentation. * Nulliparous * Cervical dilatation less than 5 cm * Spontaneous evolution * Induction or conduction of labor Exclusion Criteria: * Pre-pregnancy BMI \>30 kg/m2 or obesity * Multiple gestation * Intrauterine fetal death * Musculoskeletal problems that hinder ball use * Receiving magnesium sulfate * Premature rupture of the membrane greater than 24 hours * Cervical incompetence * High risk pregnancies (Preeclampsia/eclampsia, cholestasis, intrauterine growth retardation, fetal anomaly, polyhydramnios or oligohydramnios, heart disease, HIV). * Labor dystocia * Diagnosis of mental illness. * Multiparous.

What they're measuring

anxiety level

Timeframe: Since intervention until 8 hours

Visual Analog Pain Scale

Timeframe: Since intervention until 24 hours

Trial details

NCT IDNCT06811584

SponsorRicardo A Gutierrez Ramirez, MD, MSc, FACOG

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More Labor Stage, First trials