Peanut Ball in Labor to Reduce Anxiety and Pain (BAM)
Peanut Ball in Labor to Reduce Anxiety and Pain: Single-blind Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Francisco Morazán Department
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Tegucigalpa, Francisco Morazán Department, Honduras, 11101
- Hospital Escuela
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Peanut ball
Participants will be provided with a peanut ball, and she will be allowed to use it at least every two hours for a period of 30 minutes.
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Participants will be provided with a mani ball, which will be covered by a cover provided by the investigator. This cover will be changed for each patient. The ball will be placed between the participant's knees, and she will be allowed to use it at least every two hours for a period of 30 minutes. Participants will also have the option to use the balloon more frequently if they wish. Balloon use will be discontinued when the cervical os reaches 10 cm dilation or when the participant is ready to begin the pushing process.
Other Names:
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No Intervention: Standard management
women will not use the peanut balloon and will receive standard care for labor, which may include measures such as pharmacologic pain relief and other labor management interventions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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anxiety level
Time Frame: Since intervention until 8 hours
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Pain Anxiety Symptom Scale - Short Format 20 (PASS-20), This test measures 20 items using a Likert scale from 1 to 5, with a minimum score of 20 and a maximum of 100.
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Since intervention until 8 hours
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Visual Analog Pain Scale
Time Frame: Since intervention until 24 hours
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It is a horizontal line of 10 centimeters, at the ends of which the extreme expressions of a symptom are shown.
On the left side is located the absence or lower intensity and on the right side the higher intensity.
The patient is then asked to mark on the line the point indicating the intensity and it is measured with a millimeter ruler.
The intensity is expressed in centimeters or millimeters
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Since intervention until 24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Maternal Well-being in Childbirth Scale 2 (BMSP2)
Time Frame: Since intervention until 24 hours
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The total scale score defines three levels of maternal well-being: excellent (score > 200), adequate (score > 183 and <. 200), and poor (score < 183), the score range has a minimum of 47 and a maximum of 235
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Since intervention until 24 hours
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The Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ)
Time Frame: Since intervention until 24 hours
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measures the Fear of childbirth.
It is divided into 2 parts, part A with 32 items with a Likert scale (32 to 192 points) and part B with 30 points with a Likert scale (30 to 180 points)
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Since intervention until 24 hours
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Collaborators and Investigators
Investigators
- Study Director: Ricardo A. Gutierrez Ramirez, MD, MSc., Universidad Nacional Autonoma de Honduras
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PGO-UNAH-48-7-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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