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

Study Overview
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Brief Summary
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*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
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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.

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

Conditions
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Labor Pain

Intervention / Treatment
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* Device: Peanut Ball


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; cervical dilation is less than 5 cm; able to listen, speak, read and write in Chinese; complete the informed consent form. Exclusion Criteria: emergency cesarean section; diagnosed with metal disease or drug abuser; complicated with abnormality during labor.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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. | Device: Peanut Ball<br>* 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.<br>|
| No Intervention: Control group<br>Take the routine health brochure. The participants will be at independent compartment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| Duration of labor | Duration of labor from Medical record sheet | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peanut Ball, Labor Pain, Support and Control, Anxiety, Labor Duration