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Clinical Trials/NCT04888013
NCT04888013
Completed
Not Applicable

The Impact of Birth Environment and Childbirth-stress, Birth Control & Outcome

National Taipei University of Nursing and Health Sciences1 site in 1 country129 target enrollmentJuly 21, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Childbirth Problems
Sponsor
National Taipei University of Nursing and Health Sciences
Enrollment
129
Locations
1
Primary Endpoint
Visual Analogue Stress Scale
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This research improves the correlation between birth control and birth outcomes by understanding the childbirth environment and birth stress. A Quasi Experiment research . The sample size was calculated using a two-tailed test, the significance level α was 0.05, the power was 80%, three groups of repeated measurements were taken three times, the effect size (effect size) was set to medium.25, and the required number of samples was 108 people, resulting in a 20% wastage rate, a total of 129 people are needed, so each of the three groups is expected to accept 43 people.

Registry
clinicaltrials.gov
Start Date
July 21, 2021
End Date
November 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Sequential
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Li-li Chen

RN PhD student

National Taipei University of Nursing and Health Sciences

Eligibility Criteria

Inclusion Criteria

  • Be at least 20 years old,
  • Those who agree to participate in this research and can read and write Chinese,
  • vaginal delivery
  • Those who have no high-risk complications or chronic diseases during pregnancy and childbirth.

Exclusion Criteria

  • Those who have been diagnosed with mental illness by a doctor, including those with depression and mood disorders
  • Exclude stillbirths and newborns with congenital abnormalities

Outcomes

Primary Outcomes

Visual Analogue Stress Scale

Time Frame: From latent phase to postpartum 2 hours

The visual analogue scale for stress is a horizontal line of 0-10 cm. It is divided into the maximum level of stress. 0 means no stress at all, and 10 means extreme stress. The individual will point out the most suitable value for the feeling at this moment. Centimeters represent one point, and fractions gradually represent a decrease in the score

salivary amylase

Time Frame: From latent phase to postpartum 2 hours

he measurement standard values are as follows: 30 kIU/L is no pressure; 31\~45 kIU/L is a small amount of pressure; 46\~60 kIU/L is a moderate pressure; more than 61 kIU/L is a severe pressure.

Heart rate variability

Time Frame: From latent phase to postpartum 2 hours

The heart rate variability measurement uses TS-0411 sample, wrist-type physiological monitor (approved by the Department of Health No. 5200277), with multiple built-in biological sensors, which have been calibrated before leaving the factory to achieve high accuracy.

Secondary Outcomes

  • Perception of Childbirth Environment Scale(through study completion, an average of Postpartum 24 hours)

Study Sites (1)

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