Labor PainNCT04204395
Efficacy of Peanut Ball Usage on Labor Pain, Support and Control, Anxiety, and Labor Duration
A study testing Peanut Ball in people with Labor Pain, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
*Primary: To compare the control group, women in the experimental group will have lower level of labor pain after the intervention of peanut ball usage. *Secondary: To compare the control group, women in the experimental group will have higher level of support and control after the intervention of peanut ball usage… 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 Pain
- What is being tested?
- Peanut Ball
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Dec 2019to 30 Jun 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
- vaginal birth;
- pregnant women at ≥3 6 weeks of gestation;
- greater than 20 years old of age;
- no major obstetric or medical complications;
- singleton pregnancy;
- the partner will be accompanied during the labor;
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- cervical dilation is less than 5 cm;
- able to listen, speak, read and write in Chinese;
- complete the informed consent form.
Who cannot join
- emergency cesarean section;
- diagnosed with metal disease or drug abuser;
- complicated with abnormality during labor.
Trial locations and contacts
1 site in 1 country.
About this study
*Primary: To compare the control group, women in the experimental group will have lower level of labor pain after the intervention of peanut ball usage.
*Secondary: To compare the control group, women in the experimental group will have higher level of support and control after the intervention of peanut ball usage; To compare the control group, women in the experimental group will have lower level of anxiety after intervention of peanut ball usage; To compare the control group, women in the experimental group will have shorter duration of labor after intervention of peanut ball usage.
Read the detailed description
We will ask the participants to join this research on the department of obstetric outpatient department, and give the consent form to sign. Then we will allocate the participant into the experiment group or the control group, furthermore, we will give the sheet which includes the information about peanut ball usage, like the destination, method, position, duration, and quick response code of the video.
When they finish the admission process in the delivery room, we will give the peanut ball to the participants who is in the experimental group, and the participants of the control group will receive the routine care of delivery room.
- Conditions
- Labor Pain
- Being tested
- Peanut Ball
- Keywords
- Peanut Ball, Labor Pain, Support and Control, Anxiety, Labor Duration
- Medical subject headings
- Labor Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut BallDevice
The participants in the experimental group will use the peanut ball at least every 2 hours, 30-minute usage for each time. More frequency will be available. Then, the participants will stop using the peanut ball when cervical os is dilated and effaced, may be ready to push.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | When complete the admission process, the caregiver will give a peanut ball to perform, besides the routine health brochure.
The participants will be at independent compartment. Receives: Device: Peanut Ball |
| Control group | No intervention | Take the routine health brochure. The participants will be at independent compartment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changed perception of Pain
Perception of Pain assessed by Visual analogue scale for pain(VAS-P). Range of the VAS-P score is 0 to 10, higher scores means worse outcome.
Measured: The baseline will be assessed when the cervical dilation is during 0 to 3 centimeters. The three post-tests will be assessed when 30 minutes after each intervention, and cervical dilation is during 5 to 7 centimeters, and during 8 to 10 centimeters.
Secondary outcomes (4)
Changed perception of Support and Control in Birth
Perception of Support and Control assessed by Chinese version support and control scale in birth(C-SCIB). The range of the score is from 33 to 165, higher score means better outcome.
Measured: The baseline will be assessed when the cervical dilation is during 0 to 3 centimeters. The post-test will be assessed within 24 hours after delivery.
Changed perception of anxiety
Perception of anxiety assessed by Visual analogue scale for anxiety(VAS-A). Range of the score is 0 to 10, higher scores means worse outcome.
Measured: The baseline will be assessed when the cervical dilation is during 0 to 3 centimeters. The three post-tests will be assessed when 30 minutes after each intervention, and cervical dilation is during 5 to 7 centimeters, and during 8 to 10 centimeters.
Duration of labor
Duration of labor from Medical record sheet
Measured: within 24 hours after delivery
Changed trajectory of Heart Rate Variability
Heart Rate Variability assessed by Heart Rate Variability Device which indicates the sympathetic nervous system status.
Measured: The baseline will be assessed when the cervical dilation is during 0 to 3 centimeters. The three post-tests will be assessed when 30 minutes after each intervention, and cervical dilation is during 5 to 7 centimeters, and during 8 to 10 centimeters.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start25 Dec 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University Hospital
- Responsible party
- Sponsor
- Investigators
- Shu-Yu Kuo, PhD., Study director, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204395
- Sponsor's protocol ID
- N201910010
- Status last verified
- Nov 2019
- First submitted
- 2 Dec 2019
- Last updated
- 9 Oct 2020
- 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 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Peanut Ball Usage on Labor Pain, Support and Control, Anxiety, and Labor Duration
- ClinicalTrials.gov ID
- NCT04204395
- Acronym / sponsor ID
- N201910010
- Conditions
- Labor Pain
- Keywords
- Peanut Ball, Labor Pain, Support and Control, Anxiety, Labor Duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Taipei Medical University Hospital
- Study start
- 25 Dec 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 19 Dec 2019 (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.
*Primary: To compare the control group, women in the experimental group will have lower level of labor pain after the intervention of peanut ball usage.
*Secondary: To compare the control group, women in the experimental group will have higher level of support and control after the intervention of peanut ball usage; To compare the control group, women in the experimental group will have lower level of anxiety after intervention of peanut ball usage; To compare the control group, women in the experimental group will have shorter duration of labor after intervention of peanut ball usage.
Detailed description
We will ask the participants to join this research on the department of obstetric outpatient department, and give the consent form to sign. Then we will allocate the participant into the experiment group or the control group, furthermore, we will give the sheet which includes the information about peanut ball usage, like the destination, method, position, duration, and quick response code of the video.
When they finish the admission process in the delivery room, we will give the peanut ball to the participants who is in the experimental group, and the participants of the control group will receive the routine care of delivery room.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Peanut BallWhen complete the admission process, the caregiver will give a peanut ball to perform, besides the routine health brochure. The participants will be at independent compartment. |
| Control group | No intervention | –Take the routine health brochure. The participants will be at independent compartment. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- vaginal birth;
- pregnant women at ≥3 6 weeks of gestation;
- greater than 20 years old of age;
- no major obstetric or medical complications;
- singleton pregnancy;
Key exclusion criteria (3 listed)
- emergency cesarean section;
- diagnosed with metal disease or drug abuser;
- complicated with abnormality during 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 |
|---|---|---|
| Peanut BallThe participants in the experimental group will use the peanut ball at least every 2 hours, 30-minute usage for each time. More frequency will be available. Then, the participants will stop using the peanut ball when cervical os is dilated and effaced, may be ready to push. | Device | Experimental group |
Primary outcome
Changed perception of Pain
Time frame: The baseline will be assessed when the cervical dilation is during 0 to 3 centimeters. The three post-tests will be assessed when 30 minutes after each intervention, and cervical dilation is during 5 to 7 centimeters, and during 8 to 10 centimeters.
Perception of Pain assessed by Visual analogue scale for pain(VAS-P). Range of the VAS-P score is 0 to 10, higher scores means worse outcome.
4 secondary outcomes
Changed perception of Support and Control in Birth
Time frame: The baseline will be assessed when the cervical dilation is during 0 to 3 centimeters. The post-test will be assessed within 24 hours after delivery.
Changed perception of anxiety
Time frame: The baseline will be assessed when the cervical dilation is during 0 to 3 centimeters. The three post-tests will be assessed when 30 minutes after each intervention, and cervical dilation is during 5 to 7 centimeters, and during 8 to 10 centimeters.
Duration of labor
Time frame: within 24 hours after delivery
Changed trajectory of Heart Rate Variability
Time frame: The baseline will be assessed when the cervical dilation is during 0 to 3 centimeters. The three post-tests will be assessed when 30 minutes after each intervention, and cervical dilation is during 5 to 7 centimeters, and during 8 to 10 centimeters.
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 9 Oct 2020.
- 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.
Shu-Yu Kuo, PhD. study director
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut Ball in people with Labor Pain, run by Taipei Medical University 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 9 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 9 Oct 2020. 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?
Changed perception of Pain (time frame: The baseline will be assessed when the cervical dilation is during 0 to 3 centimeters. The three post-tests will be assessed when 30 minutes after each intervention, and cervical dilation is during 5 to 7 centimeters, and during 8 to 10 centimeters.). 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 9 Oct 2020.