Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor

Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor: A Randomized Controlled Trial

H0: There is no difference between birth satisfaction and pain levels of pregnant women who used and did not use a birth ball during labor.

H1: There is a difference between birth satisfaction and pain levels of pregnant women who used and did not use a birth ball during the birth process.

Study Overview

• Status: Completed
• Conditions: Pain; Labor Pain; Satisfaction
• Intervention / Treatment: Other: Birth Ball

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • Dr. Ali Kemal Belviranlı Gynecology and Pediatrics Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• the consent of the pregnant women to participate in the study,
• have signed the informed consent form,
• be over the age of 18,
• Vaginal opening was determined as 4 cm

Exclusion Criteria:

• Having a psychologically diagnosed disorder
• Pregnant women diagnosed with risky pregnancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Birth Ball; In the second stage, the birth ball application was made and followed. Pregnant women with a vaginal opening of 4 cm admitted to the delivery room were instructed to sit on the delivery ball for a total of 30 minutes. A stopwatch clock was used to determine these 30 minutes. The pregnant woman was not asked to sit on the ball all the time, and she could take a break for rest or other needs. The birth ball, which is suitable for women's use, was preferred in 45 cm dimensions, and the pilates circle was used as a stabilizer. Under the supervision of the researcher, the pregnant women sat upright on the ball and began to rock back and forth. Meanwhile, the researcher held the pregnant woman's hand. In order for the pregnant woman not to lose her balance, the birth ball was placed on a pilates circle and she was supported by the researcher in making the movements.	Other: Birth Ball; During labour, the pregnant woman was positioned using a birth ball.
No Intervention: Control; A routine care was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Introductory Information Form	The form consisting of 13 questions was prepared by the researcher in order to describe the sociodemographic characteristics and current health status of women.	pre-intervention
Birth Process Follow-up Form	It was created by the researcher in order to obtain information about the progress of birth and the characteristics of the fetus during the birth process of the pregnant. In the form, there are questions including the hour and subsequent follow-up hours when the vaginal opening is 4 cm, dilatation, fetal heartbeat, whether there is oxytocin administration, the duration and frequency of contractions, and the characteristics of the amniotic fluid.	during the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	It is a measurement usually used to evaluate pain from 0 (no pain) to 10 (unbearable pain). A 10 cm vertical form was used in the study. Pain level was evaluated with VAS during each follow-up of the pregnant woman.	during the intervention
Birth Satisfaction Scale-Short Form (DME-F)	The short form of the scale was revised by Martin et al. in 2016 to evaluate the birth satisfaction levels of women (Martin et al., 2016). The Turkish validity and reliability study was conducted by Serhatlıoğlu et al. in 2018 (Göncü Serhatlıoğlu et al., 2018). The scale consists of 10 items and a minimum of 0 and a maximum of 40 points can be obtained. The items of the scale are in a 5-point Likert type and are scored as Strongly agree (4 points)-Strongly Disagree (0 points).	in the first hour in postpartum period

Collaborators and Investigators

• Sponsor: Selcuk University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: April 2, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: pain; Birth ball; birth satisfaction; midwifery care
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 0000-0002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No