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Efficacy of Peanut Ball Usage on Labor Pain, Support and Control, Anxiety, and Labor Duration

Efficacy of Peanut Ball Usage on Labor Pain, Support and Control, Anxiety, and Labor Duration

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04204395
Enrollment
80
Registered
2019-12-19
Start date
2019-12-25
Completion date
2020-06-30
Last updated
2020-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

Peanut Ball, Labor Pain, Support and Control, Anxiety, Labor Duration

Brief 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; 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.

Interventions

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.

Sponsors

Taipei Medical University Hospital
CollaboratorOTHER
Taipei Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. vaginal birth; 2. pregnant women at ≥3 6 weeks of gestation; 3. greater than 20 years old of age; 4. no major obstetric or medical complications; 5. singleton pregnancy; 6. the partner will be accompanied during the labor; 7. cervical dilation is less than 5 cm; 8. able to listen, speak, read and write in Chinese; 9. complete the informed consent form.

Exclusion criteria

1. emergency cesarean section; 2. diagnosed with metal disease or drug abuser; 3. complicated with abnormality during labor.

Design outcomes

Primary

MeasureTime frameDescription
Changed perception of PainThe 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.

Secondary

MeasureTime frameDescription
Changed perception of Support and Control in BirthThe 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.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.
Changed perception of anxietyThe 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 anxiety assessed by Visual analogue scale for anxiety(VAS-A). Range of the score is 0 to 10, higher scores means worse outcome.
Duration of laborwithin 24 hours after deliveryDuration of labor from Medical record sheet
Changed trajectory of Heart Rate VariabilityThe 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.Heart Rate Variability assessed by Heart Rate Variability Device which indicates the sympathetic nervous system status.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026