Viewing Study NCT06312449



Ignite Creation Date: 2024-05-06 @ 8:16 PM
Last Modification Date: 2024-10-26 @ 3:23 PM
Study NCT ID: NCT06312449
Status: COMPLETED
Last Update Posted: 2024-03-15
First Post: 2024-02-27

Brief Title: Effect of Peanut Balls Used of the Second Stage of Labor Pushing Perceptions Fatigue and Birth Outcomes
Sponsor: Tung Yu-Ching
Organization: National Taipei University of Nursing and Health Sciences

Study Overview

Official Title: Effect of Peanut Balls Used on the Duration of the Second Stage of Labor Pushing Perceptions Fatigue and Birth Outcomes
Status: COMPLETED
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study aims to explore the use of peanut balls during the second stage of labor It compares three different positions traditional lithotomy position lateral position and lateral position with peanut ball in terms of womens perceived pushing effort experiences fatigue and birth outcomes
Detailed Description: The experimental research design involves enrolling participants during their hospitalization for childbirth After explanation and consent participants are sequentially assigned to Control Group B Control Group A and the Experimental Group The Experimental Group receives education and guidance on using a peanut ball while Control Groups receive standard care During the second stage of labor the Experimental Group assumes a side-lying position with the bed elevated at a 30-degree angle and uses the peanut ball with exertion Control Group A assumes a side-lying position with the bed elevated at a 30-degree angle without the peanut ball and Control Group B assumes a traditional lithotomy position with the bed elevated at a 30-degree angle with exertionThis study was conducted at a maternity ward in the Northern Region of a certain medical center Participants were selected through consecutive convenient samplingThe total of 192 participants for the entire studyThe research tools included1Personal basic demographic and obstetric information survey form A self-designed questionnaire to gather personal basic information2Labor exertion experience scale Adapted from the modified 10-item labor exertion experience scale designed by Chang et al 20113Visual Analog Scale for Fatigue VAS-F Employed as an assessment tool for fatigueAfter enrollment the experimental group received instructions on the intervention with the peanut ball Research staff provided guidance using an educational leaflet on the purpose timing method and precautions of using the peanut ballParticipants and their birth companions were required to demonstrate their understanding by performing the instructed actions with corrections provided as necessary

The research team members did not intervene during the execution process Care was provided by instructed caregivers who stayed with the parturients throughout the second stage of labor Each group of participants was accommodated in individual labor rooms to prevent mutual interference When the cervix was fully dilated to 10 centimeters or when the parturient felt a strong urge to push or when the fetal presenting part reached 1 centimeter below the ischial spine 1 Station instruction on closed-glottis pushing for 5-6 seconds at a time began The experimental group pushed in a side-lying position with the peanut ball while Control Group A pushed in a side-lying position and Control Group B pushed in a traditional lithotomy position Within 1-4 hours postpartum fatigue was assessed using the VAS-F at two time points T1 and T2 and participants were instructed to complete the labor exertion experience scale Finally medical records and parturition records were transcribed to complete the labor duration and related data forms

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None