NCT04204395

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

December 25, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

October 9, 2020

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

December 2, 2019

Last Update Submit

October 7, 2020

Conditions

Labor Pain

Keywords

Peanut BallLabor PainSupport and ControlAnxietyLabor Duration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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.

  • 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.

  • Duration of labor

    within 24 hours after delivery

  • 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.

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Peanut BallDEVICE

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.

Experimental group

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • emergency cesarean section;
  • diagnosed with metal disease or drug abuser;
  • complicated with abnormality during labor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Labor PainAnxiety Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Shu-Yu Kuo, PhD.

    Taipei Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2019

First Posted

December 19, 2019

Study Start

December 25, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

October 9, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)