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

NCT05312502 | Completed

• 1 other identifier: 0000-0002
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Labor Pain; Satisfaction

Keywords

Birth ball; birth satisfaction; pain; midwifery care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Visual Analog Scale (VAS)

  during the intervention

• Birth Satisfaction Scale-Short Form (DME-F)

  in the first hour in postpartum period

Study Arms (2)

Experimental: Birth Ball

EXPERIMENTAL

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

Control

NO INTERVENTION

A routine care was performed.

Interventions

Birth Ball OTHER

During labour, the pregnant woman was positioned using a birth ball.

Experimental: Birth Ball

Eligibility Criteria

• Age: 19 Years - 47 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Dr. Ali Kemal Belviranlı Gynecology and Pediatrics Hospital

Konya, Turkey (Türkiye)

Location

Related Publications (1)

• Kilic S, Dereli Yilmaz S. Virtual Reality Headset Simulating a Nature Environment to Improve Health Outcomes in Pregnant Women: A Randomized-Controlled Trial. Clin Nurs Res. 2023 Nov;32(8):1104-1114. doi: 10.1177/10547738231184923. Epub 2023 Jul 5.

  PMID: 37408298 DERIVED

MeSH Terms

Conditions

Pain; Labor Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Prof. Dr.

Model Details: The sample size was 106 pregnant women, 53 in each group, with a known score using the G\*Power 3.1.7 program (intervention group=29.19±5.86-control group=26.51±5.13) with 85% power, 0.48 effect size and 0.15 error. was calculated as. Considering data loss, it is planned to reach 10% more pregnant women. Intervention group=57, control group=54 pregnants, and the study was terminated. The women were divided into two groups using the random numbers table in the simple random sampling method. Single blinding was performed on the women participating in the study. However, in order to prevent bias, the researcher who collected the data gave codes to the questionnaire forms of the pregnant women.

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 5, 2022
• Study Start: March 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2022
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

TU (1)