LaborpeanutballNCT05557383
Effect of Using Peanut Ball on the Length of Labor for Women Laboring With an Epidural
A study testing use peanut ball in people with Labor and Epidural Anesthesia, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the Effect of using peanut ball on the length of labor, delivery pattern and childbirth satisfaction for women laboring with an Epidural.This study aims to understand the intervention of using peanut ball in the future during the delivery period is expected.it is expected to… 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
- Labor, Epidural Anesthesia
- What is being tested?
- use peanut ball
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Oct 2019to 31 Aug 2020
- 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
- Aged over 20 years old
- Full-term women who are more than 37 weeks pregnant and diagnosed as low-risk pregnancy by physicians
- Pain relief with epidural anesthesia
- Singleton
- Normal birth position ( The first part of the head)
- Know the Chinese characters and be able to communicate in Chinese and Taiwanese
- Agree to participate in this researcher.
Who cannot join
- Language communication barriers
- Any abnormality and comorbidity of the woman and fetus during labor
- No epidural anesthesia for pain relief.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Nursing Hui-Chin Chen Head Nurse
The purpose of this study is to investigate the Effect of using peanut ball on the length of labor, delivery pattern and childbirth satisfaction for women laboring with an Epidural.This study aims to understand the intervention of using peanut ball in the future during the delivery period is expected.it is expected to reduce the cesarean section with delayed delivery.
Read the detailed description
In this study, expectant mothers who used epidural anesthesia to reduce pain during delivery in the delivery room of a central medical center, including primiparous women and menstrual women, were evaluated for compliance with the acceptance criteria through the mother's manual and maternity examination data. The maternal agreed to fill out the subject consent form,After obtaining the consent form of the test subject, it is included in the research object of this trial. It is expected that 190 expectant mothers will be accepted, and 40 expectant mothers will be accepted. The research tool uses the Chinese version of the Mackey Childbirth Satisfaction Rating Scale to measure women's satisfaction with the behavioral performance of self, partner, and baby during delivery / production. The scale was agreed by the original author and translator. Use consists of six levels: overall satisfaction (3 questions), self-satisfaction (9 questions), newborns (3 questions), midwifery care workers (9 questions), physicians (6 questions), and Satisfaction with partners (2 questions), a total of 32 items. After data collection, the data will be archived and analyzed with Statistical Package for the Social Sciences (version 22.0) software.
- Conditions
- Labor, Epidural Anesthesia
- Being tested
- use peanut ball
- Keywords
- peanut ball, Length of Labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use peanut ballBehavioural
Also called usual care
The peanut ball was placed between the legs of a woman in the intervention group immediately after she received her epidural and consented to participate in the study.
| Study group | Role | What they receive |
|---|---|---|
| use peanut ball | Experimental | Registered nurses were educated by the investigators on the study protocol, and standard care was given to both the intervention and control groups.The peanut ball was placed between the legs of a woman in the intervention group immediately after she received her epidural and consented to participate in the study. Receives: Behavioral: use peanut ball |
| usual care | No intervention | usual nursing care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between peanut ball intervention and labor progress
If assign to the experimental group, will provide peanut ball interventions every 30 minutes, and assist in changing postures according to the mother's wishes, including four position. Each time the peanut balls are placed for at least 10 minutes, continuous electronic fetal monitoring is given, and the uterine contractions and fetal conditions of the expecting mother are assessed every 30 minutes. When the cervix full dilates, and fetal descends, stop using the peanut balls and be ready to labor. Control group: no intervention with peanut balls, regular care as experimental group.
Measured: Record the time of the first and second stage of labor.Data collect through study completion about 1 year. analysis with SPSS.Because the data were tested for non-normal distribution, Mann-Whitney U test (continuous variable) and χ2 (discontinuous variab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start24 Oct 2019
- Primary completion18 Jun 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaborStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-group controlled, randomized study, the intervention groups: use peanut ball, control groups: not use peanut ball
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557383
- Sponsor's protocol ID
- CG19310B
- Acronym
- peanutball
- Status last verified
- Oct 2019
- First submitted
- 13 Sep 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- 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 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Nursing Hui-Chin Chen Head Nurse
- ClinicalTrials.gov ID
- NCT05557383
- Acronym / sponsor ID
- peanutball / CG19310B
- Conditions
- Labor, Epidural Anesthesia
- Keywords
- peanut ball, Length of Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 28 Sep 2022 (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.
The purpose of this study is to investigate the Effect of using peanut ball on the length of labor, delivery pattern and childbirth satisfaction for women laboring with an Epidural.This study aims to understand the intervention of using peanut ball in the future during the delivery period is expected.it is expected to reduce the cesarean section with delayed delivery.
Detailed description
In this study, expectant mothers who used epidural anesthesia to reduce pain during delivery in the delivery room of a central medical center, including primiparous women and menstrual women, were evaluated for compliance with the acceptance criteria through the mother's manual and maternity examination data. The maternal agreed to fill out the subject consent form,After obtaining the consent form of the test subject, it is included in the research object of this trial. It is expected that 190 expectant mothers will be accepted, and 40 expectant mothers will be accepted. The research tool uses the Chinese version of the Mackey Childbirth Satisfaction Rating Scale to measure women's satisfaction with the behavioral performance of self, partner, and baby during delivery / production. The scale was agreed by the original author and translator. Use consists of six levels: overall satisfaction (3 questions), self-satisfaction (9 questions), newborns (3 questions), midwifery care workers (9 questions), physicians (6 questions), and Satisfaction with partners (2 questions), a total of 32 items. After data collection, the data will be archived and analyzed with Statistical Package for the Social Sciences (version 22.0) software.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A two-group controlled, randomized study, the intervention groups: use peanut ball, control groups: not use peanut ball
| Arm | Type | Receives |
|---|---|---|
| use peanut ball | Experimental | Behavioral: use peanut ballRegistered nurses were educated by the investigators on the study protocol, and standard care was given to both the intervention and control groups.The peanut ball was placed between the legs of a woman in the intervention group immediately after she received her epidural and consented to participate in the study. |
| usual care | No intervention | –usual nursing care. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged over 20 years old
- Full-term women who are more than 37 weeks pregnant and diagnosed as low-risk pregnancy by physicians
- Pain relief with epidural anesthesia
- Singleton
- Normal birth position ( The first part of the head)
Key exclusion criteria (3 listed)
- Language communication barriers
- Any abnormality and comorbidity of the woman and fetus during labor
- No epidural anesthesia for pain relief.
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 |
|---|---|---|
| use peanut ballAlso: usual careThe peanut ball was placed between the legs of a woman in the intervention group immediately after she received her epidural and consented to participate in the study. | Behavioural | use peanut ball |
Primary outcome
Correlation between peanut ball intervention and labor progress
Time frame: Record the time of the first and second stage of labor.Data collect through study completion about 1 year. analysis with SPSS.Because the data were tested for non-normal distribution, Mann-Whitney U test (continuous variable) and χ2 (discontinuous variab
If assign to the experimental group, will provide peanut ball interventions every 30 minutes, and assist in changing postures according to the mother's wishes, including four position. Each time the peanut balls are placed for at least 10 minutes, continuous electronic fetal monitoring is given, and the uterine contractions and fetal conditions of the expecting mother are assessed every 30 minutes. When the cervix full dilates, and fetal descends, stop using the peanut balls and be ready to labor. Control group: no intervention with peanut balls, regular care as experimental group.
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 28 Sep 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use peanut ball in people with Labor and Epidural Anesthesia, run by Taichung Veterans General Hospital 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 7 inclusion and 3 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 28 Sep 2022. 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. 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?
Correlation between peanut ball intervention and labor progress (time frame: Record the time of the first and second stage of labor.Data collect through study completion about 1 year. analysis with SPSS.Because the data were tested for non-normal distribution, Mann-Whitney U test (continuous variable) and χ2 (discontinuous variab). 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 28 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.