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Completed

NCT Number: NCT05557383

Effect of Using Peanut Ball on the Length of Labor for Women Laboring With an Epidural

The purpose of this study is to investigate the Effect of using peanut ball on the length of labor, delivery pattern and childbirth satisfaction for women laboring with an Epidural.This study aims to understand the intervention of using peanut ball in the future during the delivery period is expected.it is expected to reduce the cesarean section with delayed delivery.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

About this study

In this study, expectant mothers who used epidural anesthesia to reduce pain during delivery in the delivery room of a central medical center, including primiparous women and menstrual women, were evaluated for compliance with the acceptance criteria through the mother's manual and maternity examination data. The maternal agreed to fill out the subject consent form,After obtaining the consent form of the test subject, it is included in the research object of this trial. It is expected that 190 expectant mothers will be accepted, and 40 expectant mothers will be accepted. The research tool uses the Chinese version of the Mackey Childbirth Satisfaction Rating Scale to measure women's satisfaction with the behavioral performance of self, partner, and baby during delivery / production. The scale was agreed by the original author and translator. Use consists of six levels: overall satisfaction (3 questions), self-satisfaction (9 questions), newborns (3 questions), midwifery care workers (9 questions), physicians (6 questions), and Satisfaction with partners (2 questions), a total of 32 items. After data collection, the data will be archived and analyzed with Statistical Package for the Social Sciences (version 22.0) software.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged over 20 years old
  • Full-term women who are more than 37 weeks pregnant and diagnosed as low-risk pregnancy by physicians
  • Pain relief with epidural anesthesia
  • Singleton
  • Normal birth position ( The first part of the head)
  • Know the Chinese characters and be able to communicate in Chinese and Taiwanese
  • Agree to participate in this researcher.

Exclusion criteria

  • Language communication barriers
  • Any abnormality and comorbidity of the woman and fetus during labor
  • No epidural anesthesia for pain relief.

Treatment and study plan

use peanut ball

Behavioral

The peanut ball was placed between the legs of a woman in the intervention group immediately after she received her epidural and consented to participate in the study.

Other names: usual care

Primary outcomes

  1. Correlation between peanut ball intervention and labor progress

    Time frame: Record the time of the first and second stage of labor.Data collect through study completion about 1 year. analysis with SPSS.Because the data were tested for non-normal distribution, Mann-Whitney U test (continuous variable) and χ2 (discontinuous variab

    If assign to the experimental group, will provide peanut ball interventions every 30 minutes, and assist in changing postures according to the mother's wishes, including four position. Each time the peanut balls are placed for at least 10 minutes, continuous electronic fetal monitoring is given, and the uterine contractions and fetal conditions of the expecting mother are assessed every 30 minutes. When the cervix full dilates, and fetal descends, stop using the peanut balls and be ready to labor. Control group: no intervention with peanut balls, regular care as experimental group.

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

Department of Nursing Hui-Chin Chen Head Nurse

Acronym: peanutball

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2022
Registry last updated
Sep 28, 2022

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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