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

Not Applicable

Completed

• Conditions: Labor; Epidural Anesthesia
• Interventions: Behavioral: use peanut ball

• Registration Number: NCT05557383
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2019-10
• Study Start: 2019-10-24
• Primary Completion: 2020-06-18
• Study Completion: 2020-08-31
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-22
• Last Update Submitted: 2022-09-22
• Study First Posted: 2022-09-28
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 190

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
use peanut ball	use peanut ball	Registered nurses were educated by the investigators on the study protocol, and standard care was given to both the intervention and control groups.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.

Primary Outcome Measures

Name	Time	Method
Correlation between peanut ball intervention and labor progress	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.

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan