Birth Environment and Childbirth-stress, Control & Outcome

Study 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.

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

Conditions
-----------------
Childbirth Problems, Birth; Delayed

Intervention / Treatment
-----------------
* Other: Positive Birth Environment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>Routine care for childbirth | Other: Positive Birth Environment<br>* The intent is to surround the woman and her caregivers with specific types of auditory, visual, and tactile stim uli. One key feature of the ambient room is what is missing-the standard hospital bed. As an alternative, a portable double-sized mattress with several large pillows is set up in a corner of the room. The intent is to allow the woman freedom in positioning and to permit close contact with support people, and to limit the routine use of continuous elec tronic fetal heart rate monitoring and other technologies during normal labor. Lighting is dimmed. A wide variety of music selections are also available.<br>|
| Experimental: experimental 2<br>Building childbirth environment | Other: Positive Birth Environment<br>* The intent is to surround the woman and her caregivers with specific types of auditory, visual, and tactile stim uli. One key feature of the ambient room is what is missing-the standard hospital bed. As an alternative, a portable double-sized mattress with several large pillows is set up in a corner of the room. The intent is to allow the woman freedom in positioning and to permit close contact with support people, and to limit the routine use of continuous elec tronic fetal heart rate monitoring and other technologies during normal labor. Lighting is dimmed. A wide variety of music selections are also available.<br>|
| Experimental: experimental 1<br>Building childbirth environment and labor delivery recovery room | Other: Positive Birth Environment<br>* The intent is to surround the woman and her caregivers with specific types of auditory, visual, and tactile stim uli. One key feature of the ambient room is what is missing-the standard hospital bed. As an alternative, a portable double-sized mattress with several large pillows is set up in a corner of the room. The intent is to allow the woman freedom in positioning and to permit close contact with support people, and to limit the routine use of continuous elec tronic fetal heart rate monitoring and other technologies during normal labor. Lighting is dimmed. A wide variety of music selections are also available.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Stress Scale | 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 | From latent phase to postpartum 2 hours | 
| salivary amylase | 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. | From latent phase to postpartum 2 hours | 
| Heart rate variability | 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. | From latent phase to postpartum 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of Childbirth Environment Scale | Using LIKERT-5, the higher the score, the better the environmental experience | through study completion, an average of Postpartum 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
birth Environment, childbirth-stress, birth control, outcomes