NCT05557383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
Last Updated

September 28, 2022

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

September 13, 2022

Last Update Submit

September 22, 2022

Conditions

Keywords

peanut ballLength of Labor

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

use peanut ball

EXPERIMENTAL

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

usual care

NO INTERVENTION

usual nursing care.

Interventions

use peanut ballBEHAVIORAL

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.

Also known as: usual care
use peanut ball

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsLaboring women were recruited if they met the inclusion criteria, which included being in active labor, using an epidural for pain control
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigator and outcomes Assessor has no information for use peanut ball
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A two-group controlled, randomized study, the intervention groups: use peanut ball, control groups: not use peanut ball
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 28, 2022

Study Start

October 24, 2019

Primary Completion

June 18, 2020

Study Completion

August 31, 2020

Last Updated

September 28, 2022

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations