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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05312502
• Other study ID #: 0000-0002
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2023
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 47 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain
• Pain
• Satisfaction

Intervention

Other:
• Birth Ball
During labour, the pregnant woman was positioned using a birth ball.

Locations

Country	Name	City	State
Turkey	Dr. Ali Kemal Belviranli Gynecology and Pediatrics Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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 Serhatlioglu et al. in 2018 (Göncü Serhatlioglu 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