Using a peanut ball during labor to reduce anxiety and pain
Peanut Ball in Labor to Reduce Anxiety and Pain: Single-blind Randomized Clinical Trial
NA · Universidad Nacional Autonoma de Honduras · NCT06811584
This study tests if using a peanut ball during labor can help reduce anxiety and pain for women giving birth.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Universidad Nacional Autonoma de Honduras (other) |
| Locations | 1 site (Tegucigalpa, Francisco Morazán) |
| Trial ID | NCT06811584 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of using a peanut ball during the first stage of labor on anxiety and pain levels in women. Participants will be randomly assigned to either use the peanut ball or not during labor, allowing researchers to compare the outcomes between the two groups. The study aims to enhance the childbirth experience by exploring non-pharmacological methods to alleviate discomfort and anxiety. The initiative aligns with global efforts to promote safe and respectful maternity care.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy women aged 18 to 45 with a singleton pregnancy who are in the first stage of labor.
Not a fit: Patients with high-risk pregnancies or those with certain medical conditions that prevent the use of the peanut ball may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the childbirth experience by reducing anxiety and pain for women in labor.
How similar studies have performed: While the use of peanut balls in labor is gaining attention, this specific approach is relatively novel and has not been extensively tested in clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tegucigalpa, Francisco Morazán
- Hospital Escuela — Tegucigalpa, Francisco Morazán, Honduras (RECRUITING)
Study contacts
- Study coordinator: Ricardo A. Gutierrez Ramirez, MD, MSc
- Email: ricardo.gutierrez@unah.edu.hn
- Phone: 50497546940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Labor Stage, First, Anxiety, Pain Intensity Assessment, Peanut ball, Labor stage, first, anxiety, pain intensity assesment