Efficacy of Peanut Ball Usage on Labor Pain, Support and Control, Anxiety, and Labor Duration
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Peanut Ball
Sponsored by
About this trial
This is an interventional supportive care trial for Labor Pain focused on measuring Peanut Ball, Labor Pain, Support and Control, Anxiety, Labor Duration
Eligibility Criteria
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.
Sites / Locations
- Taipei Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
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.
Take the routine health brochure. The participants will be at independent compartment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Duration of labor
Duration of labor from Medical record sheet
Changed trajectory of Heart Rate Variability
Heart Rate Variability assessed by Heart Rate Variability Device which indicates the sympathetic nervous system status.
Full Information
NCT ID
NCT04204395
First Posted
December 2, 2019
Last Updated
October 7, 2020
Sponsor
Taipei Medical University
Collaborators
Taipei Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04204395
Brief Title
Efficacy of Peanut Ball Usage on Labor Pain, Support and Control, Anxiety, and Labor Duration
Official Title
Efficacy of Peanut Ball Usage on Labor Pain, Support and Control, Anxiety, and Labor Duration
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 25, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University
Collaborators
Taipei Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Peanut Ball, Labor Pain, Support and Control, Anxiety, Labor Duration
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Take the routine health brochure. The participants will be at independent compartment.
Intervention Type
Device
Intervention Name(s)
Peanut Ball
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changed perception of Pain
Description
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.
Time Frame
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 Measure Information:
Title
Changed perception of Support and Control in Birth
Description
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.
Time Frame
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.
Title
Changed perception of anxiety
Description
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.
Time Frame
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.
Title
Duration of labor
Description
Duration of labor from Medical record sheet
Time Frame
within 24 hours after delivery
Title
Changed trajectory of Heart Rate Variability
Description
Heart Rate Variability assessed by Heart Rate Variability Device which indicates the sympathetic nervous system status.
Time Frame
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Yu Kuo, PhD.
Organizational Affiliation
Taipei Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of Peanut Ball Usage on Labor Pain, Support and Control, Anxiety, and Labor Duration
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