An interventional study of Round Birth Ball Exercise and Peanut Birth Ball Exercise in Labor Comfort, sponsored by Kars Harakani State Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Kars Harakani State Hospital · Not applicable, Interventional, and Health services research
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.
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.
396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.
This study's enrollment of 210 is above the median of 100 across 326 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →Kars Harakani State Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Development of any obstetric complication during labor Need for emergency cesarean section during labor
Participants received the delivery unit's standard intrapartum monitoring and care provided by ward staff, with no birth-ball intervention
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.
Device: Round Birth Ball Exercise
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.
Device: Peanut Birth Ball Exercise
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.
Device: Donut Birth Ball Exercise
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.
Also known as: Swiss Ball
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.
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.
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.
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.
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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).
Supporting information: Study protocol, Icf
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Kars Harakani State Hospital