Birth Environment and Childbirth-stress, Control & Outcome

NCT04888013 | Completed

• 1 other identifier: TYGH109064
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Childbirth Problems; Birth; Delayed

Keywords

birth Environment; childbirth-stress; birth control; outcomes

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Perception of Childbirth Environment Scale

  through study completion, an average of Postpartum 24 hours

Study Arms (3)

control group

PLACEBO COMPARATOR

Routine care for childbirth

Other: Positive Birth Environment

experimental 2

EXPERIMENTAL

Building childbirth environment

Other: Positive Birth Environment

experimental 1

EXPERIMENTAL

Building childbirth environment and labor delivery recovery room

Other: Positive Birth Environment

Interventions

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.

control group; experimental 1; experimental 2

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Taoyuan General Hospital: collaborator

Study Sites (1)

Taoyuan General Hospital

Taoyuan District, 33004, Taiwan

Location

Related 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 randomised controlled trial. Trials. 2018 Nov 19;19(1):641. doi: 10.1186/s13063-018-2979-7.

  PMID: 30454075 RESULT

• 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.

  PMID: 29772012 RESULT

• 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.

  PMID: 19489810 RESULT

• 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.

  PMID: 30886935 RESULT

Study Officials

• Ll-li Chen, PhD Student

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN PhD student

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 17, 2021
• Study Start: July 21, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)