Birth, FirstNCT06200688
The Effect of Peanut Ball Application on Delivery Process
A study testing PEANUT BALL in people with Birth, First, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study was carried out to evaluate the effect of peanut ball application on labor process, birth pain, and birth comfort. The data of the study were collected between July 2021 and July 2022 in a Training and Research Hospital in Istanbul. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth, First
- What is being tested?
- PEANUT BALL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 28 May 2023
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous pregnant women
- 37w-40w gestational week (term)
- Pregnant women over the age of 18 years
Who cannot join
- Pregnant women who gave birth by cesarean section
- who had received epidural anesthesia/analgesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34430
About this study
Official title: The Effect of Peanut Ball Application on the Delivery Process, Birth Pain, and Birth Process: a Randomized Controlled Study
This study was carried out to evaluate the effect of peanut ball application on labor process, birth pain, and birth comfort. The data of the study were collected between July 2021 and July 2022 in a Training and Research Hospital in Istanbul. 115 pregnant women who met the inclusion criteria of the study were included in the sampling, and the study was completed with 102 (experimental n: 51; control n: 51) pregnant women. Data were collected with an introductory information form, visual and verbal pain scales, Birth Comfort Scale, and birth follow-up form.
Read the detailed description
A group was determined to be involved in the study after obtaining consent from the pregnant women participating in the research. The purpose of the study was explained to all pregnant women, informing them that the data would be anonymized and privacy principles would be adhered to.
Experimental Group: Pregnant women who received the peanut ball application were provided with necessary information about the ball and how to use it through visual aids showing the positions provided by the midwife. A total of 5 positions were shown to the pregnant women. The peanut ball was used when the cervical dilation reached 6 cm. Pregnant women in active labor, the transition phase, and the second stage with the peanut ball were directed to change positions every 30-45 minutes. Emphasis was placed on selecting positions in which the pregnant women felt comfortable.
Control Group: No intervention was made other than routine practices within the clinic for pregnant women. It was observed that pregnant women generally spent the time before delivery lying down and connected to electronic fetal monitoring.
In the Birth Monitoring Form, the gestational week found in the patient's file, interventions and medications applied in the first stage of labor, the situation of episiotomy application in the second stage, the newborn's birth time, and 1st and 5th APGAR scores, newborn's length, weight, head circumference, and gender were recorded. In both groups, labor pains during the dilation stage were evaluated three times using the Visual Anolog Scale (VAS) when the dilation was at 6 cm, 9 cm, and 10 cm. During this period, the pregnant women were asked to rate the pain they felt on the VAS scale from 1 to 10, and the values expressed were recorded by the researcher. The childbirth comfort scale and the form indicating mothers' views
- Conditions
- Birth, First
- Being tested
- PEANUT BALL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEANUT BALLOther
Experimental Group: Pregnant women who were applied with a peanut ball were informed about the necessary information related to the ball by the midwife with a visual representation of the positions. A total of 5 positions were shown to the pregnant women. Peanut ball was started to be used when the cervical dilation reached 6 cm. Pregnant women in the active phase, the transition phase, and the second stage of labor where the peanut ball was applied were directed to change positions every 30-45 minutes. Importance was given to selecting positions where the pregnant woman felt comfortable.
Control Group: No intervention was made other than routine practices within the clinic for pregnant women. It was generally observed that pregnant women spent the time until delivery lying down and connected to electronic fetal monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Peanut Ball Group | Experimental | In this group, pregnant women changed positions with a peanut ball during labor. Receives: Other: PEANUT BALL |
| Control Group | No intervention | No intervention was applied in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth duration
Birth duration was assessed using a partograph.
Measured: 1 day
Birth pain
Labor pains in the dilatation phase: dilation 6 cm, 9 cm and 10 cm with VAS It was evaluated 3 times in total during the time it was cm. During this period, pregnant women were asked to VAS They were asked to score the pain they felt between 1 and 10, and the expressed values were recorded by the researcher.
Measured: 8 hours
Birth comfort
The birth comfort scale was administered to pregnant women by the researcher within the first 4 hours after birth.
Measured: 15 minutes
Secondary outcomes (2)
Pregnancy introductory information
A pregnancy information form was used for all pregnant women after randomization to identify and evaluate the sociodemographic and socioeconomic information of the pregnant women.
Measured: 15 minutes
Birth Follow-up
In the Birth Follow-up Form, it is included in the hospitalization file of the pregnant woman.
gestational week, interventions and medications administered in the first stage of labor, Episiotomy application status in the second stage, newborn birth time, 1st and 5th APGAR and Newborn height, weight, head circumference and gender were evaluated and recorded.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Jul 2021
- Primary completion1 Apr 2023
- Study completion28 May 2023
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, 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
- Experimental Group: Pregnant women who received the peanut ball application were provided with necessary information about the ball and how to use it through visual aids showing the positions provided by the midwife. A total of 5 positions were shown to the pregnant women. The peanut ball was used when the cervical dilation reached 6 cm. Pregnant women in active labor, the transition phase, and the second stage with the peanut ball were directed to change positions every 30-45 minutes. Emphasis was placed on selecting positions in which the pregnant women felt comfortable. Control Group: No intervention was made other than routine practices within the clinic for pregnant women. It was observed that pregnant women generally spent the time before delivery lying down and connected to electronic fetal monitoring.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YELİZ YILDIRIM VARIŞOĞLU, Istanbul Medipol University Hospital
- Investigators
- YELİZ YILDIRIM VARIŞOĞLU, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200688
- Sponsor's protocol ID
- 745044
- Status last verified
- Dec 2023
- First submitted
- 16 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoyladi E, Yildirim Varisoglu Y. Randomized controlled trial on the effect of the peanut ball devices on the duration of active labor, labor pain and comfort. BMC Pregnancy Childbirth. 2026 Feb 17;26(1):322. doi: 10.1186/s12884-026-08720-2.
PubMed 41703489
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peanut Ball Application on the Delivery Process, Birth Pain, and Birth Process: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06200688
- Acronym / sponsor ID
- 745044
- Conditions
- Birth, First
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 28 May 2023 (actual)
- First posted
- 11 Jan 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.
This study was carried out to evaluate the effect of peanut ball application on labor process, birth pain, and birth comfort. The data of the study were collected between July 2021 and July 2022 in a Training and Research Hospital in Istanbul. 115 pregnant women who met the inclusion criteria of the study were included in the sampling, and the study was completed with 102 (experimental n: 51; control n: 51) pregnant women. Data were collected with an introductory information form, visual and verbal pain scales, Birth Comfort Scale, and birth follow-up form.
Detailed description
A group was determined to be involved in the study after obtaining consent from the pregnant women participating in the research. The purpose of the study was explained to all pregnant women, informing them that the data would be anonymized and privacy principles would be adhered to.
Experimental Group: Pregnant women who received the peanut ball application were provided with necessary information about the ball and how to use it through visual aids showing the positions provided by the midwife. A total of 5 positions were shown to the pregnant women. The peanut ball was used when the cervical dilation reached 6 cm. Pregnant women in active labor, the transition phase, and the second stage with the peanut ball were directed to change positions every 30-45 minutes. Emphasis was placed on selecting positions in which the pregnant women felt comfortable.
Control Group: No intervention was made other than routine practices within the clinic for pregnant women. It was observed that pregnant women generally spent the time before delivery lying down and connected to electronic fetal monitoring.
In the Birth Monitoring Form, the gestational week found in the patient's file, interventions and medications applied in the first stage of labor, the situation of episiotomy application in the second stage, the newborn's birth time, and 1st and 5th APGAR scores, newborn's length, weight, head circumference, and gender were recorded. In both groups, labor pains during the dilation stage were evaluated three times using the Visual Anolog Scale (VAS) when the dilation was at 6 cm, 9 cm, and 10 cm. During this period, the pregnant women were asked to rate the pain they felt on the VAS scale from 1 to 10, and the values expressed were recorded by the researcher. The childbirth comfort scale and the form indicating mothers' views
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental Group: Pregnant women who received the peanut ball application were provided with necessary information about the ball and how to use it through visual aids showing the positions provided by the midwife. A total of 5 positions were shown to the pregnant women. The peanut ball was used when the cervical dilation reached 6 cm. Pregnant women in active labor, the transition phase, and the second stage with the peanut ball were directed to change positions every 30-45 minutes. Emphasis was placed on selecting positions in which the pregnant women felt comfortable. Control Group: No intervention was made other than routine practices within the clinic for pregnant women. It was observed that pregnant women generally spent the time before delivery lying down and connected to electronic fetal monitoring.
| Arm | Type | Receives |
|---|---|---|
| Peanut Ball Group | Experimental | Other: PEANUT BALLIn this group, pregnant women changed positions with a peanut ball during labor. |
| Control Group | No intervention | –No intervention was applied in this group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Primiparous pregnant women
- 37w-40w gestational week (term)
- Pregnant women over the age of 18 years
Key exclusion criteria (2 listed)
- Pregnant women who gave birth by cesarean section
- who had received epidural anesthesia/analgesia
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 BALLExperimental Group: Pregnant women who were applied with a peanut ball were informed about the necessary information related to the ball by the midwife with a visual representation of the positions. A total of 5 positions were shown to the pregnant women. Peanut ball was started to be used when the cervical dilation reached 6 cm. Pregnant women in the active phase, the transition phase, and the second stage of labor where the peanut ball was applied were directed to change positions every 30-45 minutes. Importance was given to selecting positions where the pregnant woman felt comfortable. Control Group: No intervention was made other than routine practices within the clinic for pregnant women. It was generally observed that pregnant women spent the time until delivery lying down and connected to electronic fetal monitoring. | Other | Peanut Ball Group |
Primary outcome
Birth duration
Time frame: 1 day
Birth duration was assessed using a partograph.
Birth pain
Time frame: 8 hours
Labor pains in the dilatation phase: dilation 6 cm, 9 cm and 10 cm with VAS It was evaluated 3 times in total during the time it was cm. During this period, pregnant women were asked to VAS They were asked to score the pain they felt between 1 and 10, and the expressed values were recorded by the researcher.
Birth comfort
Time frame: 15 minutes
The birth comfort scale was administered to pregnant women by the researcher within the first 4 hours after birth.
2 secondary outcomes
Pregnancy introductory information
Time frame: 15 minutes
Birth Follow-up
Time frame: 1 day
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 11 Jan 2024.
- Derived from this study: PubMed 41703489Hoyladi E, Yildirim Varisoglu Y. Randomized controlled trial on the effect of the peanut ball devices on the duration of active labor, labor pain and comfort. BMC Pregnancy Childbirth. 2026 Feb 17;26(1):322. doi: 10.1186/s12884-026-08720-2.
- Individual participant dataSharing planned: No
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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.
YELİZ YILDIRIM VARIŞOĞLU principal investigator
Medipol University
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 Birth, First, run by Istanbul Medipol University Hospital 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 3 inclusion and 2 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 11 Jan 2024. 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?
Birth duration (time frame: 1 day). The study lists 3 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 NCT06200688, 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 11 Jan 2024.