Clinical trial NCT06811584: Peanut Ball in Labor to Reduce Anxiety and Pain
Official title: Peanut Ball in Labor to Reduce Anxiety and Pain: Single-blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labor Stage, First
Anxiety
Pain Intensity Assessment
Keywords: Peanut ball
Labor stage, first
anxiety
pain intensity assesment
Lead sponsor: Universidad Nacional Autonoma de Honduras
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 158
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, parallel-group, efficacy, superiority, single-blind clinical trial.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: The process of labor is a unique and significant experience in a woman's life, and obstetric care is constantly seeking strategies to effectively improve the experience of this crucial event.

Now in response to the growing global attention to quality and respect in maternity care, the International Childbirth Initiative (ICI) has outlined "12 steps to safe and respectful maternity care, which advocate for safe and respectful maternity care".

The declaration of rights of the World Health Organization (WHO) in the year 2021 highlights the urgency of "acting now for a safe and respectful childbirth", reinforcing the global commitment to respect, protect and fulfill the right to health, particularly maternal health. In this context, it emphasizes the need to ensure a positive, satisfactory and well-being experience during pregnancy and childbirth, in Honduras is part of this group of initiatives in order to promote an environment of respect for the mother at the time of childbirth.

Most healthy women can give birth with a minimum of medical procedures without putting at risk the mother-child binomial, the safest delivery is the one that evolves spontaneously and in which there is no unnecessary intervention, for that is necessary health facilities that have the requirements to provide delivery care and professionals who understand what are the basic needs of women during this physiological process. For decades, peanut balls have been used as a non-pharmacological complement for labor management. So far, this non-drug strategy has shown significant advantages in several aspects, among them, pain control, anxiety reduction, improvement in maternal experience and positive influence on obstetric indicators.

In the national and international context of guidelines and commitments towards safe and respectful maternal care, there is a need for a localized and specific evaluation of interventions, such as the use of the peanut balloon, to understand its efficacy in reducing anxiety and pain during labor, With the development of this study we aim to evaluate the efficacy of the use of the peanut balloon as a therapeutic intervention to reduce anxiety and pain in women during labor at Hospital Escuela Universitario in the period from June 2024 to June 2025, which could contribute to the knowledge about therapeutic practices in the obstetric context, providing solid scientific evidence on the efficacy of the use of the peanut balloon. The successful implementation of this intervention could have a positive impact on both women's experience and obstetric clinical practice, and is expected to serve to establish a protocol for the management of labor and delivery using the peanut ball.

Eligibility 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.

Primary outcomes:
measure: anxiety level
timeFrame: Since intervention until 8 hours
measure: Visual Analog Pain Scale
timeFrame: Since intervention until 24 hours
Secondary outcomes:
measure: Maternal Well-being in Childbirth Scale 2 (BMSP2)
timeFrame: Since intervention until 24 hours
measure: The Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ)
timeFrame: Since intervention until 24 hours
Other outcomes:
Locations:
city: Tegucigalpa
country: Honduras
facility: Hospital Escuela
state: Francisco Morazán
Study officials:
affiliation: Universidad Nacional Autonoma de Honduras
name: Ricardo A. Gutierrez Ramirez, MD, MSc.
role: STUDY_DIRECTOR
References:
citation: Delgado A, Katz L, Melo RS, Amorim M, Lemos A. Effectiveness of the peanut ball use for women with epidural analgesia in labour: a systematic review and meta-analysis. J Obstet Gynaecol. 2022 Jul;42(5):726-733. doi: 10.1080/01443615.2021.1997959. Epub 2022 Jan 7.