Effectiveness of a Breathing and Relaxation Technique in Antenatal Education

NCT06003946 — Not applicable, Completed, 68 participants, Zurich University of Applied Sciences

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Effectiveness of a Breathing and Relaxation Technique in Antenatal Education (BreLax Study): a Randomised Controlled Trial

RegistryNCT06003946, acronym BreLax
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, prevention
Enrollment68 (Actual)
SponsorZurich University of Applied Sciences (Other); collaborators: University of Zurich
ConditionsPregnancy
InterventionsBreLax: Antenatal education class, Standard care (control) (Behavioral)
Datesstart 2023-11-01, primary completion 2025-03-25, completion 2025-03-25, first posted 2023-08-22, last updated 2025-04-02
Locations1 site in Switzerland

Related Papers Related Patents Related Grants Related Experts
All trials for Pregnancy All trials of BreLax: Antenatal education class All trials of Standard care (control)

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Intervention group (BreLax)ExperimentalBehavioral: BreLax: Antenatal education classBreLax: midwife-led antenatal education class
Control group (Standard care)Active comparatorBehavioral: Standard care (control)Midwife-led antenatal education class
  • BreLax: Antenatal education class (Behavioral): An antenatal education class over 9 hours with information regarding pregnancy, labour and birth, pain management as well as the postpartum period with an integrated breathing and relaxation technique (prolonged exhalation in the individual rhythm) and 4 accompanying positions (standing upright, sitting supported, four-footed, supported lying on the side). In addition, participants receive a manual for independent practice at home.
  • Standard care (control) (Behavioral): An antenatal education class over 9 hours, with information regarding pregnancy, labour and birth, pain management and the postpartum period as well as some relaxation exercises.

+Outcome measures

Primary outcomes

  • Self-efficacy [13 weeks till 37 weeks of pregnancy]: Changes from baseline to after the antenatal education class measured with the german version of the childbirth self-efficacy inventory (CBSEI). The CBSEI is a 32-item scale that measures women's perceived self-efficacy towards labour. Items are scored on a scale of 1 to 10. A higher score indicates that participants are better able to cope with difficult tasks.

Secondary outcomes

  • Childbirth experience [within 4 weeks after birth]: Birth experience is assessed after birth using the german version of the childbirth experience questionnaire (CEQ 2.0) The CEQ 2.0 is a 25-item scale with four dimensions (own capacity, perceived safety, professional support and participation). Items are scored on a scale of 1 (disagree at all) to 4 (agree completely). A higher value indicates a more positive assessment of the birth experience.
  • pain management [within 4 weeks after birth]: epidural anesthesia (PDA) yes/no, nitrous oxide yes/no, Patient Controlled Analgesia (PCA) yes/no, other pain medication yes/no (medical birth record)
  • birthing position [within 4 weeks after birth]: Documented during labour and birth (medical birth record). elevated supine yes/no, lateral position yes/no, standing yes/no, 4-foot position yes/no, bathtub yes/no, sitting (stool) yes/no
  • Duration of labour [within 4 weeks after birth]: Documented during labour and birth (medical birth record)
  • Bonding [within 4 weeks after birth]: Documented during labour and birth (medical birth record). Direct skin contact after birth (Bonding) yes/no
  • 5-minute Apgar-Score [within 4 weeks after birth]: Documented during labour and birth (medical birth record). Appearance 0 to 2 (pale/ trunk rosy, extremities pale/ rosy), Pulse 0 to 2 (no Puls/ <100/min/ >100/min), Grimace 0 to 2 (No/ Grimacing/ Screaming), Activity 0 to 2 (Flaccid/ Sluggish flexion movements/ Spontaneous good self-movement), Respiration 0 to 2 (None/ Slow, irregular breathing or gasping/ Regular (40/min)). Interpretation: normal: 9-10 points; marginal: 5-8 points; critical for the newborn: <5 points.
  • arterial umbilical cord pH [within 4 weeks after birth]: Documented after labour and birth (medical birth record). Normal values in the umbilical artery blood are values of 7.20 - 7.38. At pH below 7.2 there is mild acidosis, below 7.1 moderate acidosis and below 7.0 severe acidosis.
  • Feasibility and effectiveness BreLax [13 weeks of pregnancy till 4 weeks after birth]: Self-reported by participants (digital diary and questionnaire). How often practiced before birth (text), how long practiced each time (Text) , where practiced (Text) , when used during birth (contractions irregular yes/no, contractions regular yes/no, at end of birth (pushing phase) yes/no, whole birth) yes/no.

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Zurich University of Applied SciencesWinterthur, Canton of ZurichSwitzerland

+Publications

  • 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. PMID 35581951
  • 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. PMID 23121002
  • 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. PMID 17459542
  • 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. PMID 19436529
  • 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. PMID 19583645
  • 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. PMID 23277726
  • 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. PMID 26378776
  • Results publication: Leutenegger V, Wieber F, Daly D, Sultan-Beyer L, Bagehorn J, Pehlke-Milde J. Study protocol of a breathing and relaxation intervention included in antenatal education: A randomised controlled trial (BreLax study). PLoS One. 2024 Oct 8;19(10):e0308480. doi: 10.1371/journal.pone.0308480. eCollection 2024. PMID 39378237

+Study documents

+Funding

NIH grants: 2023