Labor Stage, FirstBAMNCT06811584
Peanut Ball in Labor to Reduce Anxiety and Pain
A study testing Peanut ball in people with Labor Stage, First and Anxiety, run by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG at 1 site in Honduras.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Stage, First, Anxiety, Pain Intensity Assessment
- What is being tested?
- Peanut ball
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteHonduras
- Study dates
- 1 Feb 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- Cephalic presentation.
- Nulliparous
- Cervical dilatation less than 5 cm
- Spontaneous evolution
- Induction or conduction of labor
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Honduras1 site
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, 11101
About this study
Official title: Peanut Ball in Labor to Reduce Anxiety and Pain: Single-blind Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Labor Stage, First, Anxiety, Pain Intensity Assessment
- Being tested
- Peanut ball
- Keywords
- Peanut ball, Labor stage, first, anxiety, pain intensity assesment
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut ballDevice
Also called peanut shaped ball, peanut labor ball
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Since intervention until 24 hours
Secondary outcomes (2)
Maternal Well-being in Childbirth Scale 2 (BMSP2)
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
Measured: Since intervention until 24 hours
The Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ)
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)
Measured: Since intervention until 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Feb 2025
- Primary completion31 Jul 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Labor Stage, FirstStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, parallel-group, efficacy, superiority, single-blind clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
- Investigators
- Ricardo A. Gutierrez Ramirez, MD, MSc., Study director, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811584
- Sponsor's protocol ID
- PGO-UNAH-48-7-2025
- Acronym
- BAM
- Status last verified
- Sep 2025
- First submitted
- 31 Jan 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not necessary, none of the 18 HIPAA identifiers will be placed
Publications
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.
PubMed 34996318Zelaya IO, Soto ORR, Ventura GPM, Barahona ICF, Gutierrez-Ramirez RA. Peanut ball during labor to reduce pain and anxiety: A single-blind randomized clinical trial. Eur J Midwifery. 2026 May 30;10. doi: 10.18332/ejm/220424. eCollection 2026.
PubMed 42221709
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peanut Ball in Labor to Reduce Anxiety and Pain: Single-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06811584
- Acronym / sponsor ID
- BAM / PGO-UNAH-48-7-2025
- Conditions
- Labor Stage, First, Anxiety, Pain Intensity Assessment
- Keywords
- Peanut ball, Labor stage, first, anxiety, pain intensity assesment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Ricardo A Gutierrez Ramirez, MD, MSc, FACOGUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, parallel-group, efficacy, superiority, single-blind clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Peanut ball | Experimental | Device: Peanut ballParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- Pre-pregnancy BMI >30 kg/m2 or obesity
- Multiple gestation
- Intrauterine fetal death
- Musculoskeletal problems that hinder ball use
- Receiving magnesium sulfate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanut ballAlso: peanut shaped ball, peanut labor ballParticipants 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. | Device | Peanut ball |
Primary outcome
anxiety level
Time frame: Since intervention until 8 hours
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.
Visual Analog Pain Scale
Time frame: Since intervention until 24 hours
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
2 secondary outcomes
Maternal Well-being in Childbirth Scale 2 (BMSP2)
Time frame: Since intervention until 24 hours
The Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ)
Time frame: Since intervention until 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 34996318Delgado 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.
- Derived from this study: PubMed 42221709Zelaya IO, Soto ORR, Ventura GPM, Barahona ICF, Gutierrez-Ramirez RA. Peanut ball during labor to reduce pain and anxiety: A single-blind randomized clinical trial. Eur J Midwifery. 2026 May 30;10. doi: 10.18332/ejm/220424. eCollection 2026.
- Individual participant dataSharing planned: No. It is not necessary, none of the 18 HIPAA identifiers will be placed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo A. Gutierrez Ramirez, MD, MSc. study director
Universidad Nacional Autonoma de Honduras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut ball in people with Labor Stage, First and Anxiety, run by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG at 1 site in Honduras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety level (time frame: Since intervention until 8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06811584, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.