Effectiveness of a Breathing and Relaxation Technique in Antenatal Education

NCT06003946 | Completed DMC

• 3 other identifiers: 2023 - 000183124ZHAWUZH
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

breathing technique; birth preparation; prenatal education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Childbirth experience

  within 4 weeks after birth

• pain management

  within 4 weeks after birth

• birthing position

  within 4 weeks after birth

• Duration of labour

  within 4 weeks after birth

• Bonding

  within 4 weeks after birth

Study Arms (2)

Intervention group (BreLax)

EXPERIMENTAL

BreLax: midwife-led antenatal education class

Behavioral: BreLax: Antenatal education class

Control group (Standard care)

ACTIVE COMPARATOR

Midwife-led antenatal education class

Behavioral: Standard care (control)

Interventions

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.

Intervention group (BreLax)

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.

Control group (Standard care)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zurich University of Applied Sciences: lead
• University of Zurich: collaborator

Study Sites (1)

Zurich University of Applied Sciences

Winterthur, Canton of Zurich, 8400, Switzerland

Location

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 22, 2023
• Study Start: November 1, 2023
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

CH (1)