Birth Environment and Childbirth-stress, Control & Outcome

The Impact of Birth Environment and Childbirth-stress, Birth 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.

Study Overview

• Status: Completed
• Conditions: Childbirth Problems; Birth; Delayed
• Intervention / Treatment: Other: Positive Birth Environment

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 33004
    • Taoyuan General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; Routine care for childbirth	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.
Experimental: experimental 2; Building childbirth environment	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.
Experimental: experimental 1; Building childbirth environment and labor delivery recovery room	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.

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

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Collaborators: Taoyuan General Hospital

Publications and helpful links

General Publications

• 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 randomised controlled trial. Trials. 2018 Nov 19;19(1):641. doi: 10.1186/s13063-018-2979-7.
• 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.
• 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.
• 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 Clin Trials Commun. 2019 Feb 15;14:100336. doi: 10.1016/j.conctc.2019.100336. eCollection 2019 Jun. Erratum In: Contemp Clin Trials Commun. 2020 Dec 10;20:100690.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: May 2, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: outcomes; birth control; birth Environment; childbirth-stress
• Other Study ID Numbers: TYGH109064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No