EFFECT OF DIFFERENT TYPES OF BIRTH BALLS ON BIRTH COMFORT: A RANDOMIZED CONTROLLED TRIAL

NCT07849179 | Completed

• 1 other identifier: KarsHarakani Lazoglu0002
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Labor Comfort

Keywords

Birth ball; Peanut ball; Labor comfort; Labor pain; Randomized controlled trial; Midwifery; Non-pharmacological pain management; Comfort theory

Outcome Measures

Primary Outcomes (1)

• 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 once, within 15 minutes of completing the assigned intervention, at the end of the active phase of the first stage of labor.

Study Arms (4)

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.

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.

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.

Device: Donut Birth Ball Exercise

Interventions

Round Birth Ball Exercise DEVICE

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

Round Ball

Peanut Birth Ball Exercise DEVICE

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.

Peanut Ball

Donut Birth Ball Exercise DEVICE

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.

Donut Ball

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Development of any obstetric complication during labor Need for emergency cesarean section during labor

Sponsors & Collaborators

• Kars Harakani State Hospital: lead

Study Sites (1)

Kars Harakani State Hospital

Kars, Merkez, 36100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Merve Lazoglu, Assistant Professor

  Kafkas University, Faculty of Health Sciences, Department of Midwifery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: September 22, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 25, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims of an approved analysis plan, subject to a data use agreement.

Locations

TU (1)