Clinical trial NCT06312449: Effect of Peanut Balls Used of the Second Stage of Labor, Pushing Perceptions, Fatigue and Birth Outcomes
Official title: Effect of Peanut Balls Used on the Duration of the Second Stage of Labor, Pushing Perceptions, Fatigue and Birth Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other
Keywords: Peanut ball
Second stage of labor
Perceived effort experience
Fatigue
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
First posted: 2024-03-15
Enrollment: 162
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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 women's 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The duration of the second stage of labor of women who use side-lying with peanut balls.
timeFrame: calculated from the labor records within 24 hours postpartum, will be recorded by the researcher onto the individual basic information form.
measure: The pushing time of women in the second stage of labor who use side-lying with peanut balls.
timeFrame: As documented in the nursing records within 24 hours postpartum, will be transcribed by the researcher onto the second stage labor pushing record form.
measure: lateral position with peanut ball in terms of women's perceived pushing effort experiences.
timeFrame: Measurements will be conducted within 1 to 4 hours postpartum.
measure: Parturients using the side-lying position with a peanut ball for experience levels of fatigue.
timeFrame: Measurements will be conducted within 1 to 4 hours postpartum.
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Yu-Ching Tung
Study officials:
affiliation: Chang Gung Medical Foundation Institutional Review Board
name: Yu-Ching Tung, Nurse
role: PRINCIPAL_INVESTIGATOR
References: