Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05312502
Enrollment
111
Registered
2022-04-05
Start date
2020-03-01
Completion date
2022-12-01
Last updated
2023-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Labor Pain, Satisfaction

Keywords

Birth ball, birth satisfaction, pain, midwifery care

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.

Interventions

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

Sponsors

Selcuk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 47 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Introductory Information Formpre-interventionThe form consisting of 13 questions was prepared by the researcher in order to describe the sociodemographic characteristics and current health status of women.
Birth Process Follow-up Formduring the interventionIt 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.

Secondary

MeasureTime frameDescription
Visual Analog Scale (VAS)during the interventionIt 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.
Birth Satisfaction Scale-Short Form (DME-F)in the first hour in postpartum periodThe 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026