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

Not Applicable

Completed

• Conditions: Pain; Labor Pain; Satisfaction

• Registration Number: NCT05312502
• Lead Sponsor: Selcuk University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-06-01
• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-04-02
• Study First Posted: 2022-04-05
• Study Completion: 2022-12-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 111

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Introductory Information Form	pre-intervention	The 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 Form	during the intervention	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.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	during the intervention	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.
Birth Satisfaction Scale-Short Form (DME-F)	in the first hour in postpartum period	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).

Trial Locations

Locations (1)

Dr. Ali Kemal Belviranlı Gynecology and Pediatrics Hospital; 🇹🇷 Konya, Turkey