Peanut Ball in Labor to Reduce Anxiety and Pain

NCT06811584 | Completed DMC

• 1 other identifier: PGO-UNAH-48-7-2025
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Stage, First; Anxiety; Pain Intensity Assessment

Keywords

Peanut ball; Labor stage, first; anxiety; pain intensity assesment

Outcome Measures

Primary Outcomes (2)

• anxiety level

  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.

  Since intervention until 8 hours

• Visual Analog Pain Scale

  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

  Since intervention until 24 hours

Secondary Outcomes (2)

• Maternal Well-being in Childbirth Scale 2 (BMSP2)

  Since intervention until 24 hours

• The Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ)

  Since intervention until 24 hours

Study Arms (2)

Peanut ball

EXPERIMENTAL

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.

Device: Peanut ball

Standard management

NO INTERVENTION

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.

Interventions

Peanut ball DEVICE

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. * The positions to be performed with the peanut ball will be: * Side lying * Bent position * Semi-sitting position * Taylor position.

Also known as: peanut shaped ball, peanut labor ball

Peanut ball

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ricardo A Gutierrez Ramirez, MD, MSc, FACOG: lead

Study Sites (1)

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

Location

Related Publications (1)

• 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.

  PMID: 34996318 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ricardo A. Gutierrez Ramirez, MD, MSc.

  Universidad Nacional Autonoma de Honduras

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Both the patient and the principal investigator will know the intervention, the data analyst researcher does not know the group to which the patients have been assigned.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Titular professor

Model Details: Single-blind, parallel-group, efficacy, superiority, single-blind clinical trial.

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: February 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: September 1, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1)