Birth Outcome, AdverseNCT06387680
The Peanut Ball Use on Labor
A study of Birth Outcome, Adverse and Birth, First, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to evaluate the effect of using peanut balls during labor on labor memory, labor satisfaction, labor length, and neonatal APGAR scores. 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
- Birth Outcome, Adverse, Birth, First, Labor Long
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Mar 2024
- 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
- Pregnant women were included if they had indications for vaginal delivery,
- Were primiparous,
- Had cervical dilation of 3 cm or more,
- Had term pregnancy (38 to 42 weeks of gestation),
- Had a single,
- Healthy,
Show all 12Show fewer
- Vertex-positioned fetus,
- Had no complications that could cause dystocia during labor (contraction anomalies, birth object, dystocia related to the birth canal, dystocia related to the mother's psyche, dystocia related to the mother's psychology),
- Did not use analgesia and anesthesia during the first stage of labor,
- I did not have any physical disability to take the positions to be used in the study,
- Did not have any communication problems,
- Had language skills sufficient to speak and understand Turkish.
Who cannot join
- Pregnant women were excluded if they had abnormal changes in fetal heart rate during labor (fetal distress, etc.),
- Had an unexpected pregnancy or fetal complication,
- Had a high-risk pregnancy,
- Were taking magnesium sulfate,
- Had symptoms of intrauterine infection,
- Had previously attended antenatal classes,
- Or reported having been educated about birthing balls.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled Trial
The purpose of this study was to evaluate the effect of using peanut balls during labor on labor memory, labor satisfaction, labor length, and neonatal APGAR scores.
Read the detailed description
The purpose of this study was to evaluate the effect of using peanut balls during labor on labor memory, labor satisfaction, labor length, and neonatal APGAR scores.
This randomized, controlled, single-blind trial was conducted in 156 primiparous pregnant women (peanut ball group n=78, control group n=78) who delivered between March 2024 and October 2024. Pregnant women in the peanut ball group were instructed to perform movements with the peanut ball after cervical dilation reached 4 cm. The control group received only standard intrapartum midwifery care. Data were collected by personal information form, labor and postpartum follow-up form (APGAR score, etc.), Birth Memory and Recall Scale 4 hours after delivery, and Birth Satisfaction Scales.
- Being tested
- The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled Trial
- Keywords
- Birth memory and recall, Birth satisfaction, Labor length, APGAR score, Peanut ball
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled TrialOther
The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled Trial
| Study group | Role | What they receive |
|---|---|---|
| Peanut Ball Group | Experimental | When the cervical dilation reached 4 cm, the peanut ball was first applied to the pregnant women in the side-lying position (right side/left side) for 20 minutes, and then the pregnant women were allowed to rest for 10 minutes. Second, the semi-seated position was applied for 20 minutes and the pregnant women were allowed to rest for 10 minutes. Third, the supine position was applied for 20 minutes followed by 10 minutes of rest. Fourth, the hand-knee position was applied for 20 minutes and rested for 10 minutes. Finally, the squatting position was practiced for 20 minutes and then the pregnant women rested for 10 minutes. Each position was practiced with the peanut ball for 20 minutes and rested for 10 minutes. Each position was performed once during the procedure. A pregnant woman who wished to remain in a position longer was allowed an additional 10 minutes without interrupting the flow of the intervention and then rested for 10 minutes. Receives: Other: The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled Trial |
| Control Group | No intervention | Control Group (CG) No intervention other than routine intrapartum midwifery care was provided to primiparous pregnant women in the control group. After admission to the hospital for delivery, the pregnant women in the control group were informed about the study, written informed consent was obtained, routine practices and care in the delivery room were performed (taking history, taking vital signs, demonstrating correct breathing techniques, ensuring freedom of movement), vaginal examination and cervical changes were recorded on the partograph, EFM (electronic fetal monitoring) was performed when the time came according to the doctor's order, fetal heart rate (FHR) was listened to every half hour and recorded on the partograph. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of sociodemographic of pregnant women.
Sociodemographic of pregnant women will be collected through surveys and compared and reported.
Measured: 6 months
Comparison of obstetric characteristics of pregnant women
Obstetric of pregnant women will be collected through surveys and compared and reported.
Measured: 6 months
Comparison of postpartum characteristics of pregnant women
Postpartum characteristics of pregnant women will be collected through surveys and compared and reported.
Measured: 6 months
Comparison of duration of 1st and 2nd stage of labor by group
The 1st and 2nd stages of the birth of pregnant women will be followed by the midwife and notes will be taken in the survey.
Measured: 6 months
Comparison of 1st and 5th minute APGAR scores of newborns by group
The 1st and 5th minute APGAR scores of newborns will be noted in the survey.
Measured: 6 months
Comparison of the mean scores of the Pregnant Women's Birth Memory and Recall Questionnaire (BirthMARQ) and its subscales by groups
BirthMARQ scale will be applied to pregnant women. BirthMARQ ranges from 1 to 147 points (min-max), with higher scores indicating poor mood and more frequent involuntary recall.
Measured: 6 months
Comparison of pregnant women's Birth Satisfaction Scale (BSS) mean scores by groups
BSS scale will be applied to pregnant women.BSS is 0-40 points (min-max), and as the score increases, the level of birth satisfaction increases.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Jan 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birth Outcome, AdverseStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyhan Çankaya, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387680
- Sponsor's protocol ID
- 2022/187
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cankaya S, Alan Dikmen H, Atas A. The effect of peanut ball use on labor memory, labor satisfaction, delivery length, and neonatal APGAR score: a randomized controlled trial. Postgrad Med. 2025 Jun;137(5):368-378. doi: 10.1080/00325481.2025.2510198. Epub 2025 May 26.
PubMed 40396494
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06387680
- Acronym / sponsor ID
- 2022/187
- Keywords
- Birth memory and recall, Birth satisfaction, Labor length, APGAR score, Peanut ball
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 29 Apr 2024 (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.
The purpose of this study was to evaluate the effect of using peanut balls during labor on labor memory, labor satisfaction, labor length, and neonatal APGAR scores.
Detailed description
The purpose of this study was to evaluate the effect of using peanut balls during labor on labor memory, labor satisfaction, labor length, and neonatal APGAR scores.
This randomized, controlled, single-blind trial was conducted in 156 primiparous pregnant women (peanut ball group n=78, control group n=78) who delivered between March 2024 and October 2024. Pregnant women in the peanut ball group were instructed to perform movements with the peanut ball after cervical dilation reached 4 cm. The control group received only standard intrapartum midwifery care. Data were collected by personal information form, labor and postpartum follow-up form (APGAR score, etc.), Birth Memory and Recall Scale 4 hours after delivery, and Birth Satisfaction Scales.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peanut Ball Group | Experimental | Other: The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled TrialWhen the cervical dilation reached 4 cm, the peanut ball was first applied to the pregnant women in the side-lying position (right side/left side) for 20 minutes, and then the pregnant women were allowed to rest for 10 minutes. Second, the semi-seated position was applied for 20 minutes and the pregnant women were allowed to rest for 10 minutes. Third, the supine position was applied for 20 minutes followed by 10 minutes of rest. Fourth, the hand-knee position was applied for 20 minutes and rested for 10 minutes. Finally, the squatting position was practiced for 20 minutes and then the pregnant women rested for 10 minutes. Each position was practiced with the peanut ball for 20 minutes and rested for 10 minutes. Each position was performed once during the procedure. A pregnant woman who wished to remain in a position longer was allowed an additional 10 minutes without interrupting the flow of the intervention and then rested for 10 minutes. |
| Control Group | No intervention | –Control Group (CG) No intervention other than routine intrapartum midwifery care was provided to primiparous pregnant women in the control group. After admission to the hospital for delivery, the pregnant women in the control group were informed about the study, written informed consent was obtained, routine practices and care in the delivery room were performed (taking history, taking vital signs, demonstrating correct breathing techniques, ensuring freedom of movement), vaginal examination and cervical changes were recorded on the partograph, EFM (electronic fetal monitoring) was performed when the time came according to the doctor's order, fetal heart rate (FHR) was listened to every half hour and recorded on the partograph. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Pregnant women were included if they had indications for vaginal delivery,
- Were primiparous,
- Had cervical dilation of 3 cm or more,
- Had term pregnancy (38 to 42 weeks of gestation),
- Had a single,
Key exclusion criteria (7 listed)
- Pregnant women were excluded if they had abnormal changes in fetal heart rate during labor (fetal distress, etc.),
- Had an unexpected pregnancy or fetal complication,
- Had a high-risk pregnancy,
- Were taking magnesium sulfate,
- Had symptoms of intrauterine infection,
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 |
|---|---|---|
| The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled TrialThe Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled Trial | Other | Peanut Ball Group |
Primary outcome
Comparison of sociodemographic of pregnant women.
Time frame: 6 months
Sociodemographic of pregnant women will be collected through surveys and compared and reported.
Comparison of obstetric characteristics of pregnant women
Time frame: 6 months
Obstetric of pregnant women will be collected through surveys and compared and reported.
Comparison of postpartum characteristics of pregnant women
Time frame: 6 months
Postpartum characteristics of pregnant women will be collected through surveys and compared and reported.
Comparison of duration of 1st and 2nd stage of labor by group
Time frame: 6 months
The 1st and 2nd stages of the birth of pregnant women will be followed by the midwife and notes will be taken in the survey.
Comparison of 1st and 5th minute APGAR scores of newborns by group
Time frame: 6 months
The 1st and 5th minute APGAR scores of newborns will be noted in the survey.
Comparison of the mean scores of the Pregnant Women's Birth Memory and Recall Questionnaire (BirthMARQ) and its subscales by groups
Time frame: 6 months
BirthMARQ scale will be applied to pregnant women. BirthMARQ ranges from 1 to 147 points (min-max), with higher scores indicating poor mood and more frequent involuntary recall.
Comparison of pregnant women's Birth Satisfaction Scale (BSS) mean scores by groups
Time frame: 6 months
BSS scale will be applied to pregnant women.BSS is 0-40 points (min-max), and as the score increases, the level of birth satisfaction increases.
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 15 Apr 2025.
- Derived from this study: PubMed 40396494Cankaya S, Alan Dikmen H, Atas A. The effect of peanut ball use on labor memory, labor satisfaction, delivery length, and neonatal APGAR score: a randomized controlled trial. Postgrad Med. 2025 Jun;137(5):368-378. doi: 10.1080/00325481.2025.2510198. Epub 2025 May 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Birth Outcome, Adverse and Birth, First, run by Selcuk University at 1 site in Turkey (Türkiye).
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 12 inclusion and 7 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 15 Apr 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 Turkey (Türkiye). 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?
Comparison of sociodemographic of pregnant women. (time frame: 6 months). The study lists 7 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 NCT06387680, which also lists 1 linked publication.
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 15 Apr 2025.