Effect of Peanut Balls Used of the Second Stage of Labor, Pushing Perceptions, Fatigue and Birth Outcomes

Other Clinical Trial

Official title:

Effect of Peanut Balls Used on the Duration of the Second Stage of Labor, Pushing Perceptions, Fatigue and Birth Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06312449
• Other study ID #: 2211110001
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: September 23, 2023

Study information

• Verified date: March 2024
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 women's perceived pushing effort experiences, fatigue, and birth outcomes.

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 exertion.This study was conducted at a maternity ward in the Northern Region of a certain medical center. Participants were selected through consecutive convenient sampling.The total of 192 participants for the entire study.The research tools included:1.Personal basic demographic and obstetric information survey form: A self-designed questionnaire to gather personal basic information.2.Labor exertion experience scale: Adapted from the modified 10-item labor exertion experience scale designed by Chang et al. (2011).3.Visual Analog Scale for Fatigue (VAS-F): Employed as an assessment tool for fatigue.After 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 ball.Participants 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: September 23, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Primiparous women with a singleton fetus in cephalic presentation at 36 weeks gestation or later.
• Anticipated vaginal delivery.
• Ability to understand, speak, read, and write Chinese.
• Normal prenatal examination findings for the fetus.
• Low-risk pregnancy.
• Voluntary participation after receiving an explanation of the study.

Exclusion Criteria:

• Mothers or fetuses experiencing abnormalities during labor requiring emergency cesarean section.
• Participants unwilling to engage in the side-lying position with exertion using the peanut ball during the second stage of labor.

Related Conditions & MeSH terms

• Fatigue
• Other

Intervention

Other:
• The side-lying position with the peanut ball during the second stage of labor.
The usage of the peanut ball is divided into two stages: Stage one: The parturient assumes a side-lying position with the bed elevated to a 30-degree angle. The peanut ball is placed between the legs, allowing for leg separation. The parturient can choose to lie on either the left or right side according to preference. Stage two: When the fetal presenting part reaches 1 centimeter below the ischial spine (+1 Station), still in a side-lying position with the bed elevated to a 30-degree angle, the parturient has the option to switch sides. The peanut ball is then positioned between the legs with the knees bent together, for pushing
• During the second stage, the patient is placed in a lateral position
The parturient assumes a side-lying position with the bed elevated to a 30-degree angle. The parturient can choose to lie on either the left or right side according to preference.When the fetal presenting part reaches 1 centimeter below the ischial spine (+1 Station), still in a side-lying position with the bed elevated to a 30-degree angle, the parturient has the option to switch sides, for pushing

Locations

Country	Name	City	State
Taiwan	Yu-Ching Tung	Taoyuan City

Sponsors (2)

Lead Sponsor	Collaborator
Tung Yu-Ching	Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The duration of the second stage of labor of women who use side-lying with peanut balls.	The duration of the second stage of labor	calculated from the labor records within 24 hours postpartum, will be recorded by the researcher onto the individual basic information form.
Primary	The pushing time of women in the second stage of labor who use side-lying with peanut balls.	The second stage of labor pushing time	As documented in the nursing records within 24 hours postpartum, will be transcribed by the researcher onto the second stage labor pushing record form.
Primary	lateral position with peanut ball in terms of women's perceived pushing effort experiences.	Measuring pushing effort experiences	Measurements will be conducted within 1 to 4 hours postpartum.
Primary	Parturients using the side-lying position with a peanut ball for experience levels of fatigue.	Measuring fatigue	Measurements will be conducted within 1 to 4 hours postpartum.