Effects of Different Birthing Balls Used at the First Stage of Childbirth

March 30, 2021 updated by: Tugce Sonmez, Gaziantep Islam Science and Technology University

Effects of Different Birthing Balls Used at the First Stage of Childbirth on Birth Outcomes and Maternal Satisfaction November, 2018

The study aimed to determine the effects of different birthing balls used at the first stage of childbirth on birth outcomes and maternal satisfaction. Randomized controlled, single-blind clinical study included a total of 180 pregnant women. The study included 3 groups (A: routine hospital care, B: spherical birthing ball, C: peanut ball). Especially spherical birthing ball, were effective in reducing labor pain and facilitating faster rate of descent of the fetal head, and they increased maternal satisfaction.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The study aimed to determine the effects of different birthing balls used at the first stage of childbirth on birth outcomes and maternal satisfaction. Randomized controlled, single-blind clinical study included a total of 180 pregnant women. The study included 3 groups (A: routine hospital care, B: spherical birthing ball, C: peanut ball). Especially spherical birthing ball, were effective in reducing labor pain and facilitating faster rate of descent of the fetal head, and they increased maternal satisfaction.

IMPACT STATEMENT What is already known on this subject? Labor pain and outcomes occurring during labor are known and expected situation. Some non-pharmacological methods are applied to ensure that birth is easy and maternal satisfaction is high.

What the results of this study add? There is no studies using the peanut ball and the spherical birth ball together. In our study, it was found that both balls are effective, but the spherical birth ball is more significant.

What the implications are of these findings for clinical practice and/or further research? Our study suggested that the spherical birth ball had effective on birth outcomes. Future studies should be performed to investigate the effects of birth balls in the postpartum period, breastfeeding or prenatal period.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Mersin
      • Toroslar, Mersin, Turkey
        • Tuğçe Sönmez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • primiparous
  • admitted to the delivery room for vaginal delivery
  • 38-40 week
  • being in the latent phase of labor
  • having no obstetric risks

Exclusion Criteria:

  • undergo caesarean sections for various reasons
  • having obstetric risks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: birth ball
The positions and movements for birth ball in the active and latent phases: kneeling on the ground and leaning on the spherical birthing ball, sitting on the ball with front support, sitting positions on the spherical birthing ball, full rotation of hip, moving to the right/left, back and forth. Positions and movements were repeated every 30 minutes. The 30-minute intervals were interrupted in cases where the women were not feeling well.
Birth balls to exercise
Other Names:
  • Birth ball
  • Peanut Ball
Experimental: peanut ball
The positions and movements for the pregnant women in peanut ball: upright sitting position, forward bending positions, with backward and forward movement and swaying right and left on the peanut ball
Birth balls to exercise
Other Names:
  • Birth ball
  • Peanut Ball

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Introductory Information Form
Time Frame: when pregnant women come to the delivery room
this form consists of 7 questions regarding participants' descriptive and obstetric characteristics.
when pregnant women come to the delivery room
Visual Analogue Scale
Time Frame: Latent, active and transition phase in labor
in this scale, the participants marked the severity of their pain on a 10-cm ruler with one end stating "no pain" and the other end "worst possible pain". VAS was used to determine the severity of pain and the effectiveness of the intervention in this study.
Latent, active and transition phase in labor
Verbal Rating Scale
Time Frame: Latent, active and transition phase of labor
This scale is based on participants' choice of word that defines their pain state
Latent, active and transition phase of labor
Partogram
Time Frame: active phase of labor
This is used starting from the active phase of labor. The progress of the labor and the health status of the baby are monitored on the partogram
active phase of labor
Evaluation Scale for Maternal Satisfaction with Normal Delivery
Time Frame: within a period of 1-4 hours postpartum
This is used to assess maternal satisfaction in normal delivery. Higher total scores on the scale indicate stronger maternal satisfaction with the hospital care provided in normal delivery
within a period of 1-4 hours postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: tuğçe sönmez, Gaziantep ıslamic science and tecnology university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

March 26, 2021

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3301cukurova

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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