OtherNCT06312449
Effect of Peanut Balls Used of the Second Stage of Labor, Pushing Perceptions, Fatigue and Birth Outcomes
A study testing The side-lying position with the peanut ball during the second stage of labor. and During the second stage, the patient is placed in a lateral position in people with Other, run by Tung Yu-Ching at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Other
- What is being tested?
- The side-lying position with the peanut ball during the second stage of labor. and During the second stage, the patient is placed in a lateral position
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2023to 23 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Peanut Balls Used on the Duration of the Second Stage of Labor, Pushing Perceptions, Fatigue and Birth Outcomes
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.
Read the 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.
- Conditions
- Other
- Being tested
- The side-lying position with the peanut ball during the second stage of labor., During the second stage, the patient is placed in a lateral position
- Keywords
- Peanut ball, Second stage of labor, Perceived effort experience, Fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The side-lying position with the peanut ball during the second stage of labor.Other
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 positionOther
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
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | The second stage of delivery involves using the lateral position with peanut ball Receives: Other: The side-lying position with the peanut ball during the second stage of labor. |
| Control Group A | Placebo comparator | The second stage of delivery adopts the lateral position Receives: Other: During the second stage, the patient is placed in a lateral position |
| Control Group B | No intervention | As usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
The second stage of labor pushing time
Measured: As documented in the nursing records within 24 hours postpartum, will be transcribed by the researcher onto the second stage labor pushing record form.
lateral position with peanut ball in terms of women's perceived pushing effort experiences.
Measuring pushing effort experiences
Measured: Measurements will be conducted within 1 to 4 hours postpartum.
Parturients using the side-lying position with a peanut ball for experience levels of fatigue.
Measuring fatigue
Measured: Measurements will be conducted within 1 to 4 hours postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Mar 2023
- Primary completion20 Sep 2023
- Study completion23 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtherStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tung Yu-Ching
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Sponsor-investigator, Tung Yu-Ching, National Taipei University of Nursing and Health Sciences
- Investigators
- Yu-Ching Tung, Nurse, Principal investigator, Chang Gung Medical Foundation Institutional Review Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312449
- Sponsor's protocol ID
- 2211110001
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Peanut Balls Used on the Duration of the Second Stage of Labor, Pushing Perceptions, Fatigue and Birth Outcomes
- ClinicalTrials.gov ID
- NCT06312449
- Acronym / sponsor ID
- 2211110001
- Conditions
- Other
- Keywords
- Peanut ball, Second stage of labor, Perceived effort experience, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Tung Yu-ChingUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 23 Sep 2023 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Other: The side-lying position with the peanut ball during the second stage of labor.The second stage of delivery involves using the lateral position with peanut ball |
| Control Group A | Placebo comparator | Other: During the second stage, the patient is placed in a lateral positionThe second stage of delivery adopts the lateral position |
| Control Group B | No intervention | –As usual care |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | The experimental group |
| During the second stage, the patient is placed in a lateral positionThe 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 | Other | Control Group A |
Primary outcome
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.
The duration of the second stage of labor
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
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
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.
Measuring fatigue
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Ching Tung, Nurse principal investigator
Chang Gung Medical Foundation Institutional Review Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The side-lying position with the peanut ball during the second stage of labor. and During the second stage, the patient is placed in a lateral position in people with Other, run by Tung Yu-Ching at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.