Clinical trial NCT04204395: 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
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Peanut Ball
Labor Pain
Support and Control
Anxiety
Labor Duration
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Taipei Medical University Hospital
First posted: 2019-12-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changed perception of Pain
timeFrame: 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:
measure: Changed perception of Support and Control in Birth
timeFrame: 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.
measure: Changed perception of anxiety
timeFrame: 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.
measure: Duration of labor
timeFrame: within 24 hours after delivery
measure: Changed trajectory of Heart Rate Variability
timeFrame: 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.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Shu-Yu Kuo, PhD.
role: STUDY_DIRECTOR
References: