Clinical trial NCT06003946: Effectiveness of a Breathing and Relaxation Technique in Antenatal Education
Official title: Effectiveness of a Breathing and Relaxation Technique in Antenatal Education (BreLax Study): a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: breathing technique
birth preparation
prenatal education
Lead sponsor: Zurich University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2023-08-22
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this randomised controlled trial is to compare the effects of an antenatal education class including a breathing and relaxation technique on self-efficacy compared to a standard antenatal education class without a focus on breathing and relaxation techniques.

Detailed description: Antenatal education classes were developed to inform expectant mothers about pregnancy, labour and birth and the postpartum period with the aim of improving pregnancy and childbirth experience. They were based, for example, on concepts of Lamaze and Grantly Dick-Read. Studies indicate positive emotional effects on labour and birth outcomes in women who attended antenatal education classes. This includes lower levels of fear of childbirth, lower rates of caesarean birth at the women's request, a higher rate of spontaneous births, and a stronger involvement of the partner, better chances of initiating breastfeeding, a lower likelihood of developing depression symptoms during the postpartum period. There is limited evidence on the link between birth preparation and neonatal outcomes. Considering recent evidence suggesting that antenatal education classes may positively influence maternal and neonatal birth outcomes, we intend to analyse an antenatal education class focusing on a breathing and relaxation technique and assess the impact of such a class on self-efficacy, as well as other maternal and neonatal birth outcomes.

Eligibility criteria: Inclusion Criteria:

* pregnant women with a singleton low-risk pregnancy
* receiving antenatal care
* being willing to attend an antenatal education class
* planning a vaginal birth
* sufficient oral and written German language knowledge

Exclusion Criteria:

* women, who plan an elective caesarean section
* pregnant with multiples
* do not have sufficient oral and written German language knowledge

Primary outcomes:
measure: Self-efficacy
timeFrame: 13 weeks till 37 weeks of pregnancy
Secondary outcomes:
measure: Childbirth experience
timeFrame: within 4 weeks after birth
measure: pain management
timeFrame: within 4 weeks after birth
measure: birthing position
timeFrame: within 4 weeks after birth
measure: Duration of labour
timeFrame: within 4 weeks after birth
measure: Bonding
timeFrame: within 4 weeks after birth
measure: 5-minute Apgar-Score
timeFrame: within 4 weeks after birth
measure: arterial umbilical cord pH
timeFrame: within 4 weeks after birth
measure: Feasibility and effectiveness BreLax
timeFrame: 13 weeks of pregnancy till 4 weeks after birth
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Zurich University of Applied Sciences
state: Zurich
Study officials:
References:
citation: Shand AW, Lewis-Jones B, Nielsen T, Svensson J, Lainchbury A, Henry A, Nassar N. Birth outcomes by type of attendance at antenatal education: An observational study. Aust N Z J Obstet Gynaecol. 2022 Dec;62(6):859-867. doi: 10.1111/ajo.13541. Epub 2022 May 17.
citation: Rouhe H, Salmela-Aro K, Toivanen R, Tokola M, Halmesmaki E, Saisto T. Obstetric outcome after intervention for severe fear of childbirth in nulliparous women - randomised trial. BJOG. 2013 Jan;120(1):75-84. doi: 10.1111/1471-0528.12011. Epub 2012 Nov 2.
citation: Svensson J, Barclay L, Cooke M. Randomised-controlled trial of two antenatal education programmes. Midwifery. 2009 Apr;25(2):114-25. doi: 10.1016/j.midw.2006.12.012. Epub 2007 Apr 24.
citation: Svensson J, Barclay L, Cooke M. Effective antenatal education: strategies recommended by expectant and new parents. J Perinat Educ. 2008 Fall;17(4):33-42. doi: 10.1624/105812408X364152.
citation: Ip WY, Tang CS, Goggins WB. An educational intervention to improve women's ability to cope with childbirth. J Clin Nurs. 2009 Aug;18(15):2125-35. doi: 10.1111/j.1365-2702.2008.02720.x.
citation: Ahlden I, Ahlehagen S, Dahlgren LO, Josefsson A. Parents' expectations about participating in antenatal parenthood education classes. J Perinat Educ. 2012 Winter;21(1):11-7. doi: 10.1891/1058-1243.21.1.11.
citation: Schmidt G, Stoll K, Jager B, Gross MM. [German Version of the Childbirth Self-Efficacy Inventory and its Short Form]. Z Geburtshilfe Neonatol. 2016 Feb;220(1):28-34. doi: 10.1055/s-0035-1547296. Epub 2015 Sep 17. German.