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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04204395
• Other study ID #: N201910010
• Status: Completed
• Phase: N/A
• Start date: December 25, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2019
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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; 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

Device:
• Peanut Ball
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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	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.
Secondary	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.	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	Duration of labor	Duration of labor from Medical record sheet	within 24 hours after delivery
Secondary	Changed trajectory of Heart Rate Variability	Heart Rate Variability assessed by Heart Rate Variability Device which indicates the sympathetic nervous system status.	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.