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

*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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Device: Peanut Ball

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
NO_INTERVENTION: Control group; Take the routine health brochure. The participants will be at independent compartment.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: Taipei Medical University Hospital
• Investigators: Study Director: Shu-Yu Kuo, PhD., Taipei Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 25, 2019
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): June 30, 2020

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (ACTUAL): December 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 9, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Anxiety; Labor Pain; Peanut Ball; Support and Control; Labor Duration
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: N201910010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No