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

Introduction: In the last decade, there has been an increased interest in exploring the impact of the physical birth environment on birth outcomes. The birth environment might have an important role in facilitating the production of the hormone oxytocin that causes contractions during labour. Oxytoc...

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Main Authors: Iben Lorentzen, Charlotte Sander Andersen, Henriette Svenstrup Jensen, Ann Fogsgaard, Maralyn Foureur, Finn Friis Lauszus, Ellen Aagaard Nohr
Format: Article
Language:English
Published: Elsevier 2019-06-01
Series:Contemporary Clinical Trials Communications
Online Access:http://www.sciencedirect.com/science/article/pii/S245186541830125X
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author Iben Lorentzen
Charlotte Sander Andersen
Henriette Svenstrup Jensen
Ann Fogsgaard
Maralyn Foureur
Finn Friis Lauszus
Ellen Aagaard Nohr
author_facet Iben Lorentzen
Charlotte Sander Andersen
Henriette Svenstrup Jensen
Ann Fogsgaard
Maralyn Foureur
Finn Friis Lauszus
Ellen Aagaard Nohr
author_sort Iben Lorentzen
collection DOAJ
description Introduction: In the last decade, there has been an increased interest in exploring the impact of the physical birth environment on birth outcomes. The birth environment might have an important role in facilitating the production of the hormone oxytocin that causes contractions during labour. Oxytocin is released in a safe, secure and confidence-inducing environment, and environments focused on technology and medical interventions to achieve birth may disrupt the production of oxytocin and slow down the progress of labour. An experimental “birth environment room” was designed, inspired by knowledge from evidence-based healthcare design, which advocates bringing nature into the room to reduce stress. The purpose is to examine whether the ‘birth environment room’, with its design and decor to minimise stress, has an impact on birth outcomes and the birth experience of the woman and her partner. Materials and methods: A randomised controlled trial will recruit 680 nulliparous women at term who will be randomly allocated to either the “birth environment room” or a standard room. The study will take place at the Department of Obstetrics and Gynecology at Herning Hospital, with recruitment from May 2015. Randomisation to either the “birth environment room” or standard room takes place just before admission to a birth room during labour. The primary outcome is augmentation of labour, and the study has 80% power to detect a 10% difference between the two groups (two-sided α = 0.05). Secondary outcomes are duration of labour, use of pharmacological pain relief, mode of birth, and rating of the birth experience by women and their partners. Trial registration: NCT02478385(10/08/2016).
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spelling doaj.art-75596cf4eab14c4f8b41997eb65991ff2022-12-21T18:11:55ZengElsevierContemporary Clinical Trials Communications2451-86542019-06-0114Study protocol for a randomised trial evaluating the effect of a “birth environment room” versus a standard labour room on birth outcomes and the birth experienceIben Lorentzen0Charlotte Sander Andersen1Henriette Svenstrup Jensen2Ann Fogsgaard3Maralyn Foureur4Finn Friis Lauszus5Ellen Aagaard Nohr6Department of Gynecology and Obstetrics, Gl. Landevej 61, 7400 Herning, Denmark; Corresponding author.Department of Gynecology and Obstetrics, Gl. Landevej 61, 7400 Herning, DenmarkDepartment of Gynecology and Obstetrics, Gl. Landevej 61, 7400 Herning, DenmarkDepartment of Gynecology and Obstetrics, Gl. Landevej 61, 7400 Herning, DenmarkCentre for Midwifery, Child and Family Health, University of Technology Sydney, Level 11, Room 109, Building 10, City Campus, PO Box 123 Broadway, Sydney, NSW 2007, AustraliaDepartment of Gynecology and Obstetrics, Gl. Landevej 61, 7400 Herning, DenmarkResearch Unit for Obstetrics and Gynecology, Institute of Clinical Research, University of Southern Denmark, Campusvej 55, 5230 Odense C, Denmark; Centre of Women's, Family and Child Health, University of South-Eastern Norway, Kongsberg, NorwayIntroduction: In the last decade, there has been an increased interest in exploring the impact of the physical birth environment on birth outcomes. The birth environment might have an important role in facilitating the production of the hormone oxytocin that causes contractions during labour. Oxytocin is released in a safe, secure and confidence-inducing environment, and environments focused on technology and medical interventions to achieve birth may disrupt the production of oxytocin and slow down the progress of labour. An experimental “birth environment room” was designed, inspired by knowledge from evidence-based healthcare design, which advocates bringing nature into the room to reduce stress. The purpose is to examine whether the ‘birth environment room’, with its design and decor to minimise stress, has an impact on birth outcomes and the birth experience of the woman and her partner. Materials and methods: A randomised controlled trial will recruit 680 nulliparous women at term who will be randomly allocated to either the “birth environment room” or a standard room. The study will take place at the Department of Obstetrics and Gynecology at Herning Hospital, with recruitment from May 2015. Randomisation to either the “birth environment room” or standard room takes place just before admission to a birth room during labour. The primary outcome is augmentation of labour, and the study has 80% power to detect a 10% difference between the two groups (two-sided α = 0.05). Secondary outcomes are duration of labour, use of pharmacological pain relief, mode of birth, and rating of the birth experience by women and their partners. Trial registration: NCT02478385(10/08/2016).http://www.sciencedirect.com/science/article/pii/S245186541830125X
spellingShingle Iben Lorentzen
Charlotte Sander Andersen
Henriette Svenstrup Jensen
Ann Fogsgaard
Maralyn Foureur
Finn Friis Lauszus
Ellen Aagaard Nohr
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
Contemporary Clinical Trials Communications
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url http://www.sciencedirect.com/science/article/pii/S245186541830125X
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