Effectiveness of a Breathing and Relaxation Technique in Antenatal Education

NCT ID: NCT06003946

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-03-25

Brief Summary

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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

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention group (BreLax)

BreLax: midwife-led antenatal education class

Group Type EXPERIMENTAL

BreLax: Antenatal education class

Intervention Type 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.

Control group (Standard care)

Midwife-led antenatal education class

Group Type ACTIVE_COMPARATOR

Standard care (control)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

Zurich University of Applied Sciences

OTHER

Sponsor Role lead

Responsible Party

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Vanessa Leutenegger

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zurich University of Applied Sciences

Winterthur, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 35581951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23121002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17459542 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19436529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19583645 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23277726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26378776 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39378237 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ZHAW

Identifier Type: OTHER

Identifier Source: secondary_id

UZH

Identifier Type: OTHER

Identifier Source: secondary_id

2023 - 000183124

Identifier Type: -

Identifier Source: org_study_id

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