Effectiveness of a Breathing and Relaxation Technique in Antenatal Education

Pregnancy Clinical Trial

— BreLax  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06003946
• Other study ID #: 2023 - 000183124
• Secondary ID: ZHAWUZH
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Zurich University of Applied Sciences
• Contact: Vanessa Leutenegger, RM, MScN
• Phone: +41589344369
• Email: vanessa.leutenegger[@]zhaw.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy
• Respiratory Aspiration

Intervention

Behavioral:
• BreLax: Antenatal education class
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)
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.

Locations

Country	Name	City	State
Switzerland	Zurich University of Applied Sciences	Winterthur	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Zurich University of Applied Sciences	University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-efficacy	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.	13 weeks till 37 weeks of pregnancy
Secondary	Childbirth experience	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.	within 4 weeks after birth
Secondary	pain management	epidural anesthesia (PDA) yes/no, nitrous oxide yes/no, Patient Controlled Analgesia (PCA) yes/no, other pain medication yes/no (medical birth record)	within 4 weeks after birth
Secondary	birthing position	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	within 4 weeks after birth
Secondary	Duration of labour	Documented during labour and birth (medical birth record)	within 4 weeks after birth
Secondary	Bonding	Documented during labour and birth (medical birth record). Direct skin contact after birth (Bonding) yes/no	within 4 weeks after birth
Secondary	5-minute Apgar-Score	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.	within 4 weeks after birth
Secondary	arterial umbilical cord pH	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.	within 4 weeks after birth
Secondary	Feasibility and effectiveness BreLax	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.	13 weeks of pregnancy till 4 weeks after birth