Birth Environment and Childbirth-stress, Control & Outcome

Childbirth Problems Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04888013
• Other study ID #: TYGH109064
• Status: Completed
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: March 2023
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Birth; Delayed
• Childbirth Problems

Intervention

Other:
• Positive 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.

Locations

Country	Name	City	State
Taiwan	Taoyuan General Hospital	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences	Taoyuan General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Ayerle GM, Schafers R, Mattern E, Striebich S, Haastert B, Vomhof M, Icks A, Ronniger Y, Seliger G. Effects of the birthing room environment on vaginal births and client-centred outcomes for women at term planning a vaginal birth: BE-UP, a multicentre ran — View Citation

Downe S, Finlayson K, Oladapo OT, Bonet M, Gulmezoglu AM. Correction: What matters to women during childbirth: A systematic qualitative review. PLoS One. 2018 May 17;13(5):e0197791. doi: 10.1371/journal.pone.0197791. eCollection 2018. — View Citation

Hodnett ED, Stremler R, Weston JA, McKeever P. Re-conceptualizing the hospital labor room: the PLACE (pregnant and laboring in an ambient clinical environment) pilot trial. Birth. 2009 Jun;36(2):159-66. doi: 10.1111/j.1523-536X.2009.00311.x. — View Citation

Lorentzen I, Andersen CS, Jensen HS, Fogsgaard A, Foureur M, Lauszus FF, Nohr EA. Study protocol for a randomised trial evaluating the effect of a "birth environment room" versus a standard labour room on birth outcomes and the birth experience. Contemp C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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