|- candidate number||12911|
|- NTR Number||NTR3490|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-jun-2012|
|- Secondary IDs||1227 METC MMC|
|- Public Title||Evaluation of the Origo prototype for enhancing women's labor & delivery experience.|
|- Scientific Title||Evaluation of the Origo prototype for enhancing women's labor & delivery experience.|
|- hypothesis||We hypothesise that Origo, an experience design concept that supports the woman during labor in a personal and unobtrusive way by providing real-time breathing support and visualizing progress of labor, will enhance the woman s labor & delivery experience in the hospital by means of ambient experience design (AE).We assume the use of the Origo App and the Origo system in the delivery room will give both patient and her partner more confidence and leads to less fear of childbirth.|
|- Healt Condition(s) or Problem(s) studied||Labour, Experience, Support|
|- Inclusion criteria||1. Maternal age ≥ 18 years;|
3. Singleton pregnancy;
4. Planned vaginal delivery;
5. Gestational age beyond 20 weeks;
6. Dutch speaking.
|- Exclusion criteria||1. High patients (tertiary care)-risk;|
2. Known fetal anomaly.
|- mec approval received||no|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2012|
|- planned closingdate||1-aug-2013|
|- Target number of participants||140|
|- Interventions||Origo, an experience design concept that supports the woman during labor in a personal and unobtrusive way by providing real-time breathing support and visualizing progress of labor.
‘Origo’ consists of an App and a special conditioned delivery room. The App can be used during pregnancy as well as during labor, both at home and in the hospital. Furthermore, the delivery room is equipped with an AE system, which is built on the App with which the woman end her partner are already familiar with. It contains an interactive light animation that is coupled to physiological data obtained by contraction monitoring (which is standard equipment present in any delivery room), and results in a unique memento after the delivery.
Pregnant women will be randomized to the Origo concept or to care as usual.
|- Primary outcome||The primary outcome measure will be maternal quality of life. |
|- Secondary outcome||1. Experiences of the loved ones of the participants;|
2. Experiences of the clinical staff;
3. Need for painrelief during labour.
|- Timepoints||One year duration of the study.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| C. Verhoeven|
|- CONTACT for SCIENTIFIC QUERIES|| C. Verhoeven|
|- Sponsor/Initiator ||Máxima Medical Center|
(Source(s) of Monetary or Material Support)
|Maxima Medical Center|
|- Publications||Buitendijk, S.E., (2010) 'Vrouwen moeten zeggenschap terugkrijgen over bevalling. De stem van vroede vrouwen'. Oratie Geneeskunde van mw. prof. dr. S.E. Buitendijk, bijzonder hoogleraar Eerstelijns Verloskunde en Ketenzorg|
Ford, R.C. and Myron, D. (2000) Creating Customer-focused Health Care Organizations. Health Care Management Review 25(4), 18-33.
Goodman, P., Mackey, M.C. and Tavakoli, A.S. (2004) Issues and innovations in nursing practice: Factors related to childbirth satisfaction. Journal of Advanced Nursing 46(2), 212-219.
Rijnders, M., Baston, H., Schönbeck, Y., van der Pal, K., Prins, M. Green, J. and Buitendijk, S. (2008) Perinatal factors related to negative or positive recall of birth experience in woman 3 years postpartum in the Netherlands. Birth 35(2), 107-116.
|- Brief summary||Randomized trial to gain insights into the value of the proposition ‘Origo’ for women and their loved ones, medical staff and care institution. |
|- Main changes (audit trail)|
|- RECORD||19-jun-2012 - 6-jul-2012|