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

NCT ID: NCT05557383

Last Updated: 2022-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-24

Study Completion Date

2020-08-31

Brief Summary

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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

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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.

Conditions

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Labor Epidural Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A two-group controlled, randomized study, the intervention groups: use peanut ball, control groups: not use peanut ball
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigator and outcomes Assessor has no information for use peanut ball

Study Groups

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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.

Group Type EXPERIMENTAL

use peanut ball

Intervention Type 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.

usual care

usual nursing care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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usual care

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CG19310B

Identifier Type: -

Identifier Source: org_study_id

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