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

Primary Purpose

Labor Pain, Satisfaction, Patient, Labor Fast

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
balls
Sponsored by
Gaziantep Islam Science and Technology University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring birth ball, labor pain, satisfaction, maternal, fetal

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Tuğçe Sönmez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

birth ball

peanut ball

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Introductory Information Form
this form consists of 7 questions regarding participants' descriptive and obstetric characteristics.
Visual Analogue Scale
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.
Verbal Rating Scale
This scale is based on participants' choice of word that defines their pain state
Partogram
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
Evaluation Scale for Maternal Satisfaction with Normal Delivery
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

Secondary Outcome Measures

Full Information

First Posted
March 26, 2021
Last Updated
March 30, 2021
Sponsor
Gaziantep Islam Science and Technology University
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1. Study Identification

Unique Protocol Identification Number
NCT04827797
Brief Title
Effects of Different Birthing Balls Used at the First Stage of Childbirth
Official Title
Effects of Different Birthing Balls Used at the First Stage of Childbirth on Birth Outcomes and Maternal Satisfaction November, 2018
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziantep Islam Science and Technology University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Satisfaction, Patient, Labor Fast
Keywords
birth ball, labor pain, satisfaction, maternal, fetal

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
birth ball
Arm Type
Experimental
Arm Description
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.
Arm Title
peanut ball
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
balls
Other Intervention Name(s)
Birth ball, Peanut Ball
Intervention Description
Birth balls to exercise
Primary Outcome Measure Information:
Title
Introductory Information Form
Description
this form consists of 7 questions regarding participants' descriptive and obstetric characteristics.
Time Frame
when pregnant women come to the delivery room
Title
Visual Analogue Scale
Description
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.
Time Frame
Latent, active and transition phase in labor
Title
Verbal Rating Scale
Description
This scale is based on participants' choice of word that defines their pain state
Time Frame
Latent, active and transition phase of labor
Title
Partogram
Description
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
Time Frame
active phase of labor
Title
Evaluation Scale for Maternal Satisfaction with Normal Delivery
Description
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
Time Frame
within a period of 1-4 hours postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tuğçe sönmez
Organizational Affiliation
Gaziantep ıslamic science and tecnology university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuğçe Sönmez
City
Toroslar
State/Province
Mersin
Country
Turkey

12. IPD Sharing Statement

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

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