Labor ComfortBBBCNCT07849179
EFFECT OF DIFFERENT TYPES OF BIRTH BALLS ON BIRTH COMFORT: A RANDOMIZED CONTROLLED TRIAL
A study testing Round Birth Ball Exercise, Peanut Birth Ball Exercise and Donut Birth Ball Exercise in people with Labor Comfort, run by Kars Harakani State Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial compared the effects of three types of birth balls (round, peanut, and donut) used during the first stage of labor on labor comfort in primiparous women, relative to routine intrapartum care alone. 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 Comfort
- What is being tested?
- Round Birth Ball Exercise, Peanut Birth Ball Exercise and Donut Birth Ball Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 31 Dec 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparity (first pregnancy, no prior live birth) At least a primary-school education No communication barrier No high-risk pregnancy No chronic illness Being in the latent phase of labor at enrollment Intact (unruptured) amniotic membranes at enrollment
Who cannot join
- Development of any obstetric complication during labor Need for emergency cesarean section during labor
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kars Harakani State Hospital
Kars, Merkez, 36100
About this study
This randomized controlled trial compared the effects of three types of birth balls (round, peanut, and donut) used during the first stage of labor on labor comfort in primiparous women, relative to routine intrapartum care alone. Two hundred ten women were randomly assigned to one of four groups (control, round ball, peanut ball, or donut ball) using a lottery method. Participants in the intervention groups performed a 30-minute supervised exercise routine on their assigned ball during the latent and active phases of labor, in addition to routine care. Labor comfort was measured at the end of the active phase using the Birth Comfort Scale. The study tested the hypothesis that birth ball use increases labor comfort compared with routine care, and explored whether comfort differs by ball type, including the donut ball, which had not previously been evaluated in published research.
Read the detailed description
Childbirth is a significant and intimate experience, and comfort during labor is an important, patient-centered dimension of maternity care quality, alongside traditional indicators such as maternal and neonatal outcomes. Birth balls are simple, non-invasive, low-cost tools increasingly used by midwives to enhance comfort during labor by facilitating comfortable positioning, reducing pressure on the ischial tuberosities, relieving low-back and pelvic pressure, and promoting a sense of control and self-efficacy. While round and peanut balls have been studied previously, the donut ball had not been evaluated in the published literature as a labor-comfort intervention prior to this trial.
This open-label, four-arm, parallel-group randomized controlled trial was conducted in the delivery unit of Kars Harakani State Hospital, Kars, Türkiye, between 1 August and 30 December 2023. Primiparous women in the latent phase of labor were randomized 1:1:1:1 via a lottery method to routine care alone (control), or routine care plus 30 minutes of supervised exercise (rocking, rotation, and gentle bouncing combined with breathing exercises) on a round ball, peanut ball, or donut ball during the latent and active phases.The primary outcome, labor comfort, was assessed at the end of the active phase using the 9-item Turkish Birth Comfort Scale (range 9-45, higher scores indicating greater comfort), administered via face-to-face interview by the researcher. Of 210 women randomized, 200 (n=50 per group) completed the intervention and outcome assessment and were included in the per-protocol analysis. Statistical analyses included one-way ANOVA and Kruskal-Wallis tests with post-hoc comparisons, ANCOVA adjusting for prenatal-education attendance (which differed at baseline), exploratory factor analysis of the outcome scale, multivariable linear regression, and effect-size and statistical power analyses for all pairwise comparisons.
- Conditions
- Labor Comfort
- Being tested
- Round Birth Ball Exercise, Peanut Birth Ball Exercise, Donut Birth Ball Exercise
- Keywords
- Birth ball, Peanut ball, Labor comfort, Labor pain, Randomized controlled trial, Midwifery, Non-pharmacological pain management, Comfort theory
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Round Birth Ball ExerciseDevice
Also called Swiss Ball
A 30-minute supervised exercise session (hip rotations, forward-backward and side-to-side rocking, and gentle bouncing combined with breathing exercises) performed while seated on a round exercise ball (55, 65, or 75 cm diameter, selected according to participant height) during the latent and active phases of the first stage of labor, in addition to routine intrapartum care.
Peanut Birth Ball ExerciseDevice
A 30-minute supervised exercise session (forward-backward and side-to-side rocking, forward-leaning, and gentle bouncing combined with breathing exercises) performed while seated on a peanut-shaped ball (40, 50, 60, or 70 cm depending on height/position) during the latent and active phases of the first stage of labor, in addition to routine intrapartum care.
Donut Birth Ball ExerciseDevice
A 30-minute supervised exercise session (forward-backward and side-to-side rocking, forward-leaning, and gentle bouncing combined with breathing exercises) performed while seated on a donut-shaped ball (45×65 cm) during the latent and active phases of the first stage of labor, in addition to routine intrapartum care.
| Study group | Role | What they receive |
|---|---|---|
| Control (Routine Care) | No intervention | Participants received the delivery unit's standard intrapartum monitoring and care provided by ward staff, with no birth-ball intervention |
| Round Ball | Experimental | In addition to routine care, participants sat on a round exercise ball (55, 65, or 75 cm, selected by height) during the latent and active phases and performed hip rotations, rocking, and gentle bouncing combined with breathing exercises, for 30 minutes during contractions, under researcher supervision. Receives: Device: Round Birth Ball Exercise |
| Peanut Ball | Experimental | In addition to routine care, participants sat on a peanut-shaped ball (40, 50, 60, or 70 cm depending on height/position) during the latent and active phases and performed rocking, forward-leaning, and gentle bouncing combined with breathing exercises, for 30 minutes during contractions, under researcher supervision. Receives: Device: Peanut Birth Ball Exercise |
| Donut Ball | Experimental | In addition to routine care, participants sat on a donut-shaped ball (45×65 cm) during the latent and active phases and performed rocking, forward-leaning, and gentle bouncing combined with breathing exercises, for 30 minutes during contractions, under researcher supervision. Receives: Device: Donut Birth Ball Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth Comfort Scale (BCS) Total Score
The Birth Comfort Scale (BCS) is a 9-item, 5-point Likert-type patient-reported instrument adapted from Kolcaba's Comfort Theory and validated in Turkish. Each item is scored from 1 ("strongly disagree") to 5 ("strongly agree"), with three items reverse-scored; total scores range from 9 to 45, with higher scores indicating greater labor comfort. In this study, the scale demonstrated excellent internal consistency (Cronbach's α = 0.93) and a unidimensional structure (one component explaining 66.3% of variance), so only the total score was used for group comparisons.
Measured: Measured once, within 15 minutes of completing the assigned intervention, at the end of the active phase of the first stage of labor.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Aug 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor ComfortStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This was a four-arm, parallel-group, randomized controlled trial with a 1:1:1:1 allocation ratio. Primiparous women in the latent phase of labor were randomly assigned to one of four groups using a lottery method: routine intrapartum care alone (control), or routine care plus 30 minutes of supervised exercise on one of three birth ball types (round ball, peanut ball, or donut ball) during the latent and active phases of the first stage of labor. Each participant received only the intervention corresponding to her assigned group, with no crossover between arms.
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kars Harakani State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Lazoğlu, Kafkas University
- Investigators
- Merve Lazoglu, Assistant Professor, Principal investigator, Kafkas University, Faculty of Health Sciences, Department of Midwifery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849179
- Sponsor's protocol ID
- KarsHarakani Lazoglu0002
- Acronym
- BBBC
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article (after de-identification) will be made available to researchers who provide a methodologically sound proposal, upon reasonable request to the corresponding author (Merve Lazoğlu, merve.aksakalli@hotmail.com).
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF DIFFERENT TYPES OF BIRTH BALLS ON BIRTH COMFORT: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07849179
- Acronym / sponsor ID
- BBBC / KarsHarakani Lazoglu0002
- Conditions
- Labor Comfort
- Keywords
- Birth ball, Peanut ball, Labor comfort, Labor pain, Randomized controlled trial, Midwifery, Non-pharmacological pain management, Comfort theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Kars Harakani State HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 30 Sep 2026 (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 randomized controlled trial compared the effects of three types of birth balls (round, peanut, and donut) used during the first stage of labor on labor comfort in primiparous women, relative to routine intrapartum care alone. Two hundred ten women were randomly assigned to one of four groups (control, round ball, peanut ball, or donut ball) using a lottery method. Participants in the intervention groups performed a 30-minute supervised exercise routine on their assigned ball during the latent and active phases of labor, in addition to routine care. Labor comfort was measured at the end of the active phase using the Birth Comfort Scale. The study tested the hypothesis that birth ball use increases labor comfort compared with routine care, and explored whether comfort differs by ball type, including the donut ball, which had not previously been evaluated in published research.
Detailed description
Childbirth is a significant and intimate experience, and comfort during labor is an important, patient-centered dimension of maternity care quality, alongside traditional indicators such as maternal and neonatal outcomes. Birth balls are simple, non-invasive, low-cost tools increasingly used by midwives to enhance comfort during labor by facilitating comfortable positioning, reducing pressure on the ischial tuberosities, relieving low-back and pelvic pressure, and promoting a sense of control and self-efficacy. While round and peanut balls have been studied previously, the donut ball had not been evaluated in the published literature as a labor-comfort intervention prior to this trial.
This open-label, four-arm, parallel-group randomized controlled trial was conducted in the delivery unit of Kars Harakani State Hospital, Kars, Türkiye, between 1 August and 30 December 2023. Primiparous women in the latent phase of labor were randomized 1:1:1:1 via a lottery method to routine care alone (control), or routine care plus 30 minutes of supervised exercise (rocking, rotation, and gentle bouncing combined with breathing exercises) on a round ball, peanut ball, or donut ball during the latent and active phases.The primary outcome, labor comfort, was assessed at the end of the active phase using the 9-item Turkish Birth Comfort Scale (range 9-45, higher scores indicating greater comfort), administered via face-to-face interview by the researcher. Of 210 women randomized, 200 (n=50 per group) completed the intervention and outcome assessment and were included in the per-protocol analysis. Statistical analyses included one-way ANOVA and Kruskal-Wallis tests with post-hoc comparisons, ANCOVA adjusting for prenatal-education attendance (which differed at baseline), exploratory factor analysis of the outcome scale, multivariable linear regression, and effect-size and statistical power analyses for all pairwise comparisons.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This was a four-arm, parallel-group, randomized controlled trial with a 1:1:1:1 allocation ratio. Primiparous women in the latent phase of labor were randomly assigned to one of four groups using a lottery method: routine intrapartum care alone (control), or routine care plus 30 minutes of supervised exercise on one of three birth ball types (round ball, peanut ball, or donut ball) during the latent and active phases of the first stage of labor. Each participant received only the intervention corresponding to her assigned group, with no crossover between arms.
| Arm | Type | Receives |
|---|---|---|
| Control (Routine Care) | No intervention | –Participants received the delivery unit's standard intrapartum monitoring and care provided by ward staff, with no birth-ball intervention |
| Round Ball | Experimental | Device: Round Birth Ball ExerciseIn addition to routine care, participants sat on a round exercise ball (55, 65, or 75 cm, selected by height) during the latent and active phases and performed hip rotations, rocking, and gentle bouncing combined with breathing exercises, for 30 minutes during contractions, under researcher supervision. |
| Peanut Ball | Experimental | Device: Peanut Birth Ball ExerciseIn addition to routine care, participants sat on a peanut-shaped ball (40, 50, 60, or 70 cm depending on height/position) during the latent and active phases and performed rocking, forward-leaning, and gentle bouncing combined with breathing exercises, for 30 minutes during contractions, under researcher supervision. |
| Donut Ball | Experimental | Device: Donut Birth Ball ExerciseIn addition to routine care, participants sat on a donut-shaped ball (45×65 cm) during the latent and active phases and performed rocking, forward-leaning, and gentle bouncing combined with breathing exercises, for 30 minutes during contractions, under researcher supervision. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Primiparity (first pregnancy, no prior live birth) At least a primary-school education No communication barrier No high-risk pregnancy No chronic illness Being in the latent phase of labor at enrollment Intact (unruptured) amniotic membranes at enrollment
Key exclusion criteria (1 listed)
- Development of any obstetric complication during labor Need for emergency cesarean section during labor
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 |
|---|---|---|
| Round Birth Ball ExerciseAlso: Swiss BallA 30-minute supervised exercise session (hip rotations, forward-backward and side-to-side rocking, and gentle bouncing combined with breathing exercises) performed while seated on a round exercise ball (55, 65, or 75 cm diameter, selected according to participant height) during the latent and active phases of the first stage of labor, in addition to routine intrapartum care. | Device | Round Ball |
| Peanut Birth Ball ExerciseA 30-minute supervised exercise session (forward-backward and side-to-side rocking, forward-leaning, and gentle bouncing combined with breathing exercises) performed while seated on a peanut-shaped ball (40, 50, 60, or 70 cm depending on height/position) during the latent and active phases of the first stage of labor, in addition to routine intrapartum care. | Device | Peanut Ball |
| Donut Birth Ball ExerciseA 30-minute supervised exercise session (forward-backward and side-to-side rocking, forward-leaning, and gentle bouncing combined with breathing exercises) performed while seated on a donut-shaped ball (45×65 cm) during the latent and active phases of the first stage of labor, in addition to routine intrapartum care. | Device | Donut Ball |
Primary outcome
Birth Comfort Scale (BCS) Total Score
Time frame: Measured once, within 15 minutes of completing the assigned intervention, at the end of the active phase of the first stage of labor.
The Birth Comfort Scale (BCS) is a 9-item, 5-point Likert-type patient-reported instrument adapted from Kolcaba's Comfort Theory and validated in Turkish. Each item is scored from 1 ("strongly disagree") to 5 ("strongly agree"), with three items reverse-scored; total scores range from 9 to 45, with higher scores indicating greater labor comfort. In this study, the scale demonstrated excellent internal consistency (Cronbach's α = 0.93) and a unidimensional structure (one component explaining 66.3% of variance), so only the total score was used for group comparisons.
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 20 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article (after de-identification) will be made available to researchers who provide a methodologically sound proposal, upon reasonable request to the corresponding author (Merve Lazoğlu, merve.aksakalli@hotmail.com).
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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.
Merve Lazoglu, Assistant Professor principal investigator
Kafkas University, Faculty of Health Sciences, Department of Midwifery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Round Birth Ball Exercise, Peanut Birth Ball Exercise and Donut Birth Ball Exercise in people with Labor Comfort, run by Kars Harakani State 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 1 inclusion and 1 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 20 Oct 2026. 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 Comfort Scale (BCS) Total Score (time frame: Measured once, within 15 minutes of completing the assigned intervention, at the end of the active phase of the first stage of labor.). 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 20 Oct 2026.