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

NCT ID: NCT04204395

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-25
• Study Completion Date: 2020-06-30

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.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental group

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.

Group Type: EXPERIMENTAL

Peanut Ball

Intervention Type: DEVICE

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.

Control group

Take the routine health brochure. The participants will be at independent compartment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University Hospital

OTHER

Sponsor Role: collaborator

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shu-Yu Kuo, PhD.

Role: STUDY_DIRECTOR

Taipei Medical University

Locations

Taipei Medical University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N201910010

Identifier Type: -

Identifier Source: org_study_id