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Completed

NCT Number: NCT04888013

Birth Environment and Childbirth-stress, Control & Outcome

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.

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Key information

Conditions

Childbirth Problems Birth; Delayed

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Taoyuan General Hospital

Taoyuan, 33004, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive Birth Environment

Other

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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

  1. Perception of Childbirth Environment Scale

    Time frame: through study completion, an average of Postpartum 24 hours

    Using LIKERT-5, the higher the score, the better the environmental experience

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Collaborators

  • Taoyuan General Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 17, 2021
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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