Peanut Ball in Labor to Reduce Anxiety and Pain (NCT06811584) | Clinical Trial Compass
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 range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
anxiety level
Timeframe: Since intervention until 8 hours
2
Visual Analog Pain Scale
Timeframe: Since intervention until 24 hours
Trial details
NCT IDNCT06811584
SponsorRicardo A Gutierrez Ramirez, MD, MSc, FACOG