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Clinical Trials/NCT06003946
NCT06003946
Completed
Not Applicable

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

Zurich University of Applied Sciences1 site in 1 country68 target enrollmentNovember 1, 2023
ConditionsPregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Zurich University of Applied Sciences
Enrollment
68
Locations
1
Primary Endpoint
Self-efficacy
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
March 25, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Zurich University of Applied Sciences
Responsible Party
Principal Investigator
Principal Investigator

Vanessa Leutenegger

PhD Student

Zurich University of Applied Sciences

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

Outcomes

Primary Outcomes

Self-efficacy

Time Frame: 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

  • Feasibility and effectiveness BreLax(13 weeks of pregnancy till 4 weeks after birth)
  • birthing position(within 4 weeks after birth)
  • Bonding(within 4 weeks after birth)
  • Duration of labour(within 4 weeks after birth)
  • 5-minute Apgar-Score(within 4 weeks after birth)
  • Childbirth experience(within 4 weeks after birth)
  • pain management(within 4 weeks after birth)
  • arterial umbilical cord pH(within 4 weeks after birth)

Study Sites (1)

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