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

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Device: Peanut Ball

• Registration Number: NCT04204395
• Lead Sponsor: Taipei Medical University

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.

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-19
• Study Start: 2019-12-25
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Peanut Ball	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.

Primary Outcome Measures

Name	Time	Method
Changed perception of Pain	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan