- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06312449
Effect of Peanut Balls Used of the Second Stage of Labor, Pushing Perceptions, Fatigue and Birth Outcomes
Effect of Peanut Balls Used on the Duration of the Second Stage of Labor, Pushing Perceptions, Fatigue and Birth Outcomes
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taoyuan City, Taiwan
- Yu-Ching Tung
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The experimental group
The second stage of delivery involves using the lateral position with peanut ball
|
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 |
Placebo Comparator: Control Group A
The second stage of delivery adopts the 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
|
No Intervention: Control Group B
As usual care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The duration of the second stage of labor of women who use side-lying with peanut balls.
Time Frame: calculated from the labor records within 24 hours postpartum, will be recorded by the researcher onto the individual basic information form.
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The duration of the second stage of labor
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calculated from the labor records within 24 hours postpartum, will be recorded by the researcher onto the individual basic information form.
|
The pushing time of women in the second stage of labor who use side-lying with peanut balls.
Time Frame: As documented in the nursing records within 24 hours postpartum, will be transcribed by the researcher onto the second stage labor pushing record form.
|
The second stage of labor pushing time
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As documented in the nursing records within 24 hours postpartum, will be transcribed by the researcher onto the second stage labor pushing record form.
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lateral position with peanut ball in terms of women's perceived pushing effort experiences.
Time Frame: Measurements will be conducted within 1 to 4 hours postpartum.
|
Measuring pushing effort experiences
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Measurements will be conducted within 1 to 4 hours postpartum.
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Parturients using the side-lying position with a peanut ball for experience levels of fatigue.
Time Frame: Measurements will be conducted within 1 to 4 hours postpartum.
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Measuring fatigue
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Measurements will be conducted within 1 to 4 hours postpartum.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yu-Ching Tung, Nurse, Chang Gung Medical Foundation Institutional Review Board
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2211110001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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