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Completed

NCT Number: NCT04204395

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.

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Key information

Conditions

Labor Pain Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, 110, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peanut Ball

Device

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 outcomes

  1. Changed perception of Pain

    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.

    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 outcomes

  1. Changed perception of Support and Control in Birth

    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.

    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.

  2. Changed perception of anxiety

    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.

    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.

  3. Duration of labor

    Time frame: within 24 hours after delivery

    Duration of labor from Medical record sheet

  4. Changed trajectory of Heart Rate Variability

    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.

    Heart Rate Variability assessed by Heart Rate Variability Device which indicates the sympathetic nervous system status.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Collaborators

  • Taipei Medical University Hospital

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 19, 2019
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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