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Birth Environment and Childbirth-stress, Control & Outcome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04888013
Enrollment
129
Registered
2021-05-17
Start date
2021-07-21
Completion date
2022-11-30
Last updated
2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth; Delayed, Childbirth Problems

Keywords

birth Environment, childbirth-stress, birth control, outcomes

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.

Interventions

OTHERPositive Birth Environment

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.

Sponsors

Taoyuan General Hospital
CollaboratorOTHER_GOV
National Taipei University of Nursing and Health Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Stress ScaleFrom latent phase to postpartum 2 hoursThe 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 amylaseFrom latent phase to postpartum 2 hourshe 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 variabilityFrom latent phase to postpartum 2 hoursThe 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

MeasureTime frameDescription
Perception of Childbirth Environment Scalethrough study completion, an average of Postpartum 24 hoursUsing LIKERT-5, the higher the score, the better the environmental experience

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026