Clinical trial NCT04888013: Birth Environment and Childbirth-stress, Control & Outcome
Official title: The Impact of Birth Environment and Childbirth-stress, Birth Control & Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childbirth Problems
Birth; Delayed
Keywords: birth Environment
childbirth-stress
birth control
outcomes
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Taoyuan General Hospital
First posted: 2021-05-17
Enrollment: 129
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Stress Scale
timeFrame: From latent phase to postpartum 2 hours
measure: salivary amylase
timeFrame: From latent phase to postpartum 2 hours
measure: Heart rate variability
timeFrame: From latent phase to postpartum 2 hours
Secondary outcomes:
measure: Perception of Childbirth Environment Scale
timeFrame: through study completion, an average of Postpartum 24 hours
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Taoyuan General Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Ll-li Chen, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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 Clin Trials Commun. 2019 Feb 15;14:100336. doi: 10.1016/j.conctc.2019.100336. eCollection 2019 Jun.