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

Department of Nursing Hui-Chin Chen Head Nurse

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.

Study Overview

• Status: Completed
• Conditions: Labor; Epidural Anesthesia
• Intervention / Treatment: Behavioral: use peanut ball

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 Type: Interventional
• Enrollment (Actual): 190
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: use peanut ball; 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
No Intervention: usual care; usual nursing care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between peanut ball intervention and labor progress	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.	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

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2019
• Primary Completion (Actual): June 18, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: peanut ball; Length of Labor
• Other Study ID Numbers: CG19310B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No