ExerciseNCT06808620
The Effect of Using Peanuts Balls at Birth
A study testing The group where the peanut ball is used in people with Exercise and Labor, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The necessity of applying the research on humans, whether the application has been done in our country or in other countries before, if it has been done, additional data expected from this study or differences from this study from others, and the expected benefits, please explain within the framework of scientific… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- The group where the peanut ball is used
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2024to 30 May 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
- Pregnant women should be in their 38-42nd weeks of pregnancy
- Cervical dilation should be 3 cm or more
- Single live baby
- Vertex position should be
- No health problems
- No communication problems
Show all 10Show fewer
- No risky pregnancies
- Those who can have vaginal birth
- Primiparous pregnancy
- Active phase
Who cannot join
- Indication for Caesarean section
- Complications during delivery
- Unwilling to continue working
- Risky pregnancies
- Pregnant women without inclusion criteria
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Using Peanut Balls During Labor on Perceived Labor Pain, Duration, and Self-Efficacy: A Randomized Controlled Study
The necessity of applying the research on humans, whether the application has been done in our country or in other countries before, if it has been done, additional data expected from this study or differences from this study from others, and the expected benefits, please explain within the framework of scientific data.
With this planned study, it is aimed to increase the activities of pregnant women during birth by using peanut balls during the birth process, to support the pregnant women psychologically, to reduce labor pains, to shorten the duration of normal birth, to increase self-efficacy for normal birth, to reduce cesarean section rates, to increase labor satisfaction, to reduce fear of birth, to expand the pelvic diameter, to stretch the pelvic muscles and to provide positive gains on connective tissues. With this planned study, it is aimed to reduce labor pain, to shorten the duration of labor and to increase the self-efficacy of the pregnant women for vaginal birth by using peanut balls during the birth process and benefiting from the stated benefits.
Read more
When the literature review was done, it was determined that partial studies were conducted on the effect of peanut balls on birth in Turkey and in the world, and it was determined that peanut balls are not used in delivery rooms in Turkey despite having many benefits on birth. This study aims to pioneer the widespread use of peanut balls in Turkey. This study was planned to determine the effect of using peanut balls on labor duration, perceived labor pain and self-efficacy in primiparous pregnant women with a cervical dilation of 4 cm and above, in line with the vaginal birth plan. The aim of the planned study is to evaluate the effect of changing position with peanut balls during labor on perceived labor pain, labor duration and self-efficacy levels for normal birth.
The hypotheses of the study proposed for this purpose are; H1: Labor pain, duration and self-efficacy of pregnant women who use peanut balls during labor are different from the control group.
H2: Perceived labor pain decreases in pregnant women who use peanut balls during labor compared to the control group.
H3: The duration of labor (the time period from the active phase to the completion of the transition phase) is shortened in pregnant women who use peanut balls during labor compared to the control group.
H4: The duration of labor (the second stage of labor) is shortened in pregnant women who use peanut balls during labor compared to the control group.
H5: Using peanut balls during birth increases the self-efficacy level in pregnant women compared to the control group.
The peanut ball will be applied in 6 different positions. These positions will consist of side-lying positions, half-sitting pose, forward bending pose and squatting positions. The positions to be applied are planned as in-bed. Pregnant women will be informed about the positions to be applied. The peanut ball will be applied for 20-25 minutes and a 5-10 minute break will be given. The introductory and obstetric information form will be filled out once for each patient. The partograph will be started with the start of the peanut ball use and will end with the end of labor. The visual comparison scale (VAS) and the self-efficacy scale for normal labor will be used 3 times in this study. It will be applied when the dilation is 4 cm and below before the application, immediately after the peanut ball application and half an hour after the peanut ball application.
Read the detailed description
Even if there is no risk, the success of the labor is shaped by the mobility, general well-being and needs of the pregnant woman. While social support is provided in line with the principles of individualized care during labor, positioning the woman in the most comfortable positions positively affects the sense of control during labor. This reduces unnecessary interventions and the possibility of cesarean section during labor. Peanut-shaped birth balls are popular in countries with high vaginal birth rates and among researchers. Reducing labor pain and keeping labor durations at an optimum level is possible with non-pharmacological methods. It has been proven that using peanut balls during labor reduces cesarean section rates, increases maternal satisfaction with perceived labor success, and shortens labor pain and labor duration. Using peanut balls during labor makes it easier for pregnant women to move into different positions safely and comfortably. Despite the known benefits of peanut balls, they are not common in births in Turkey. To our knowledge, although some birth balls are observed to be used during labor, no study has been found testing the perception of self-sufficiency during labor shaped by the perceived labor pain, labor duration and feelings of control of peanut balls during labor. The planned research is a pretest-posttest randomized control group experimental study to examine the effect of using peanut balls during labor on perceived labor pain, duration and self-efficacy. The universe of the research will consist of pregnant women who apply to Hakkari Yüksekova Maternity and Childbirth Hospital for vaginal delivery. The sample of the research was calculated with power analysis. "Descriptive and Obstetric Information Form", "Visual Comparison Scale (VAS)", "Partograph" and "Self-efficacy Scale for Normal Delivery" will be used to collect the data. Different position changes will be applied to the study group with peanut balls during labor. The control group will benefit from the hospital's routine care. The partograph will end with the end of labor. VAS and self-efficacy scale for normal delivery will be used 3 times. Descriptive statistics in the analysis will be applied according to the results obtained from normal distribution tests, parametric or nonparametric tests will be applied.
- Being tested
- The group where the peanut ball is used
- Keywords
- Labor Pain, Labor Duration, Self-Sufficiency, Peanut Ball, Vaginal Birth
- Medical subject headings
- Motor Activity, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group where the peanut ball is usedOther
Also called The group which has no implementation
Before the application, the appropriate ball size for the physical characteristics and comfort of the pregnant women will be determined. Pregnant women will be given 4 different sizes of peanut balls with a diameter of 40, 55, 65 and 75 cm. In order for the pregnant woman to continue her in-bed balance exercises and position changes, she will be allowed to sit on the peanut ball with her knees and hips at an angle of approximately 90° and her spine upright. A 40-55 cm birthing ball will be used for women between 150-160 cm tall, a 65 cm birthing ball for women between 160-170 cm tall, and a 75 cm birthing ball for women between 170-185 cm tall. Position changes with the peanut ball will be carried out in accordance with a position/exercise guide prepared by researchers in line with literature information. The peanut ball will be applied in 6 different positions. These positions to be applied will consist of side-lying positions, semi-sitting pose, forward bending pose and squatting pos
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Control | No intervention | The group which has no implementation |
| Use of peanut ball | Experimental | The group which peanut ball are implemented Receives: Other: The group where the peanut ball is used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived labor pain (Visual Analog Scale)
The visual analog scale (VAS) was developed by Price et al. (1983) to determine the level of perceived pain during labor. VAS is used easily and conveniently by converting some situations that are difficult to measure quantitatively into numerical values (Yeşilyurt and Faydalı, 2020). The visual comparison scale is in the form of a 10 cm vertical and horizontal ruler. In order to determine the intensity of pain, one end indicates the lowest level of perceived pain and the other end indicates that the intensity of pain increases. If there is no perceived pain, "0" is shown, and the number "10" indicates the highest level of pain. The pregnant woman in pain evaluates her own pain out of 10 and indicates the appropriate number for herself. A score of 1-4 on this scale indicates mild pain, 5-6 indicates moderate pain, and a score above 7 indicates severe pain (Ayan et al., 2013). No cut-off point is specified in the visual comparison scale. Its use is recommended in comparative studies
Measured: During labor
Labor duration
Effect of using peanut ball on labor duration
Measured: Labor
Perception of Self-Efficacy for Normal Birth
Effect of using peanut ball on self-efficacy perception for normal birth
Measured: During labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start30 Oct 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Randomized Controlled Study
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Citil Canbay, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808620
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/295
- Status last verified
- Aug 2024
- First submitted
- 11 Oct 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not want to provide information about plans to share individual participant data (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Peanut Balls During Labor on Perceived Labor Pain, Duration, and Self-Efficacy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06808620
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/295
- Keywords
- Labor Pain, Labor Duration, Self-Sufficiency, Peanut Ball, Vaginal Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 5 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.
The necessity of applying the research on humans, whether the application has been done in our country or in other countries before, if it has been done, additional data expected from this study or differences from this study from others, and the expected benefits, please explain within the framework of scientific data.
With this planned study, it is aimed to increase the activities of pregnant women during birth by using peanut balls during the birth process, to support the pregnant women psychologically, to reduce labor pains, to shorten the duration of normal birth, to increase self-efficacy for normal birth, to reduce cesarean section rates, to increase labor satisfaction, to reduce fear of birth, to expand the pelvic diameter, to stretch the pelvic muscles and to provide positive gains on connective tissues. With this planned study, it is aimed to reduce labor pain, to shorten the duration of labor and to increase the self-efficacy of the pregnant women for vaginal birth by using peanut balls during the birth process and benefiting from the stated benefits.
When the literature review was done, it was determined that partial studies were conducted on the effect of peanut balls on birth in Turkey and in the world, and it was determined that peanut balls are not used in delivery rooms in Turkey despite having many benefits on birth. This study aims to pioneer the widespread use of peanut balls in Turkey. This study was planned to determine the effect of using peanut balls on labor duration, perceived labor pain and self-efficacy in primiparous pregnant women with a cervical dilation of 4 cm and above, in line with the vaginal birth plan. The aim of the planned study is to evaluate the effect of changing position with peanut balls during labor on perceived labor pain, labor duration and self-efficacy levels for normal birth.
The hypotheses of the study proposed for this purpose are; H1: Labor pain, duration and self-efficacy of pregnant women who use peanut balls during labor are different from the control group.
H2: Perceived labor pain decreases in pregnant women who use peanut balls during labor compared to the control group.
H3: The duration of labor (the time period from the active phase to the completion of the transition phase) is shortened in pregnant women who use peanut balls during labor compared to the control group.
H4: The duration of labor (the second stage of labor) is shortened in pregnant women who use peanut balls during labor compared to the control group.
H5: Using peanut balls during birth increases the self-efficacy level in pregnant women compared to the control group.
The peanut ball will be applied in 6 different positions. These positions will consist of side-lying positions, half-sitting pose, forward bending pose and squatting positions. The positions to be applied are planned as in-bed. Pregnant women will be informed about the positions to be applied. The peanut ball will be applied for 20-25 minutes and a 5-10 minute break will be given. The introductory and obstetric information form will be filled out once for each patient. The partograph will be started with the start of the peanut ball use and will end with the end of labor. The visual comparison scale (VAS) and the self-efficacy scale for normal labor will be used 3 times in this study. It will be applied when the dilation is 4 cm and below before the application, immediately after the peanut ball application and half an hour after the peanut ball application.
Detailed description
Even if there is no risk, the success of the labor is shaped by the mobility, general well-being and needs of the pregnant woman. While social support is provided in line with the principles of individualized care during labor, positioning the woman in the most comfortable positions positively affects the sense of control during labor. This reduces unnecessary interventions and the possibility of cesarean section during labor. Peanut-shaped birth balls are popular in countries with high vaginal birth rates and among researchers. Reducing labor pain and keeping labor durations at an optimum level is possible with non-pharmacological methods. It has been proven that using peanut balls during labor reduces cesarean section rates, increases maternal satisfaction with perceived labor success, and shortens labor pain and labor duration. Using peanut balls during labor makes it easier for pregnant women to move into different positions safely and comfortably. Despite the known benefits of peanut balls, they are not common in births in Turkey. To our knowledge, although some birth balls are observed to be used during labor, no study has been found testing the perception of self-sufficiency during labor shaped by the perceived labor pain, labor duration and feelings of control of peanut balls during labor. The planned research is a pretest-posttest randomized control group experimental study to examine the effect of using peanut balls during labor on perceived labor pain, duration and self-efficacy. The universe of the research will consist of pregnant women who apply to Hakkari Yüksekova Maternity and Childbirth Hospital for vaginal delivery. The sample of the research was calculated with power analysis. "Descriptive and Obstetric Information Form", "Visual Comparison Scale (VAS)", "Partograph" and "Self-efficacy Scale for Normal Delivery" will be used to collect the data. Different position changes will be applied to the study group with peanut balls during labor. The control group will benefit from the hospital's routine care. The partograph will end with the end of labor. VAS and self-efficacy scale for normal delivery will be used 3 times. Descriptive statistics in the analysis will be applied according to the results obtained from normal distribution tests, parametric or nonparametric tests will be applied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Control | No intervention | –The group which has no implementation |
| Use of peanut ball | Experimental | Other: The group where the peanut ball is usedThe group which peanut ball are implemented |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Pregnant women should be in their 38-42nd weeks of pregnancy
- Cervical dilation should be 3 cm or more
- Single live baby
- Vertex position should be
- No health problems
Key exclusion criteria (6 listed)
- Indication for Caesarean section
- Complications during delivery
- Unwilling to continue working
- Risky pregnancies
- Pregnant women without inclusion criteria
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 group where the peanut ball is usedAlso: The group which has no implementationBefore the application, the appropriate ball size for the physical characteristics and comfort of the pregnant women will be determined. Pregnant women will be given 4 different sizes of peanut balls with a diameter of 40, 55, 65 and 75 cm. In order for the pregnant woman to continue her in-bed balance exercises and position changes, she will be allowed to sit on the peanut ball with her knees and hips at an angle of approximately 90° and her spine upright. A 40-55 cm birthing ball will be used for women between 150-160 cm tall, a 65 cm birthing ball for women between 160-170 cm tall, and a 75 cm birthing ball for women between 170-185 cm tall. Position changes with the peanut ball will be carried out in accordance with a position/exercise guide prepared by researchers in line with literature information. The peanut ball will be applied in 6 different positions. These positions to be applied will consist of side-lying positions, semi-sitting pose, forward bending pose and squatting pos | Other | Use of peanut ball |
Primary outcome
Perceived labor pain (Visual Analog Scale)
Time frame: During labor
The visual analog scale (VAS) was developed by Price et al. (1983) to determine the level of perceived pain during labor. VAS is used easily and conveniently by converting some situations that are difficult to measure quantitatively into numerical values (Yeşilyurt and Faydalı, 2020). The visual comparison scale is in the form of a 10 cm vertical and horizontal ruler. In order to determine the intensity of pain, one end indicates the lowest level of perceived pain and the other end indicates that the intensity of pain increases. If there is no perceived pain, "0" is shown, and the number "10" indicates the highest level of pain. The pregnant woman in pain evaluates her own pain out of 10 and indicates the appropriate number for herself. A score of 1-4 on this scale indicates mild pain, 5-6 indicates moderate pain, and a score above 7 indicates severe pain (Ayan et al., 2013). No cut-off point is specified in the visual comparison scale. Its use is recommended in comparative studies
Labor duration
Time frame: Labor
Effect of using peanut ball on labor duration
Perception of Self-Efficacy for Normal Birth
Time frame: During labor
Effect of using peanut ball on self-efficacy perception for normal birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No. I do not want to provide information about plans to share individual participant data (IPD).
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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 testing The group where the peanut ball is used in people with Exercise and Labor, run by Ataturk 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 10 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Feb 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?
Results are not available in the source record.
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?
Perceived labor pain (Visual Analog Scale) (time frame: During labor). 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?
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 5 Feb 2025.