Birth Environment and Childbirth-stress, Control & Outcome

Not Applicable

Completed

• Conditions: Childbirth Problems; Birth; Delayed
• Interventions: Other: Positive Birth Environment

• Registration Number: NCT04888013
• Lead Sponsor: National Taipei University of Nursing and Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-02
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-17
• Study Start: 2021-07-21
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 129

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
experimental 2	Positive Birth Environment	Building childbirth environment
control group	Positive Birth Environment	Routine care for childbirth
experimental 1	Positive Birth Environment	Building childbirth environment and labor delivery recovery room

Primary Outcome Measures

Name	Time	Method
Visual Analogue Stress Scale	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	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	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 Outcome Measures

Name	Time	Method
Perception of Childbirth Environment Scale	through study completion, an average of Postpartum 24 hours	Using LIKERT-5, the higher the score, the better the environmental experience

Trial Locations

Locations (1)

Taoyuan General Hospital; 🇨🇳 Taoyuan, Taiwan