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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04827797
• Other study ID #: 3301cukurova
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: March 2021
• Source: Gaziantep Islamic University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 20, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Fast
• Labor Pain
• Satisfaction, Patient

Intervention

Device:
• balls
Birth balls to exercise

Locations

Country	Name	City	State
Turkey	Tugçe Sönmez	Toroslar	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Gaziantep Islamic University of Science and Technology

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Introductory Information Form	this form consists of 7 questions regarding participants' descriptive and obstetric characteristics.	when pregnant women come to the delivery room
Primary	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.	Latent, active and transition phase in labor
Primary	Verbal Rating Scale	This scale is based on participants' choice of word that defines their pain state	Latent, active and transition phase of labor
Primary	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	active phase of labor
Primary	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	within a period of 1-4 hours postpartum