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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain Labor Pain Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Birth Ball

Intervention Type OTHER

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

Control

A routine care was performed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Birth Ball

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

Intervention Type OTHER

Eligibility Criteria

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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