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OpenTrials
Completed

NCT Number: NCT05312502

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

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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Key information

Age range

19 year–47 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Ali Kemal Belviranlı Gynecology and Pediatrics Hospital

Konya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Birth Ball

Other

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

Primary outcomes

  1. Introductory Information Form

    Time frame: 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.

  2. Birth Process Follow-up Form

    Time frame: 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 outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 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.

  2. Birth Satisfaction Scale-Short Form (DME-F)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 5, 2022
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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