Effectiveness of a Breathing and Relaxation Technique in Antenatal Education (BreLax)

March 26, 2025 updated by: Vanessa Leutenegger, Zurich University of Applied Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Zurich
      • Winterthur, Zurich, Switzerland, 8400
        • Zurich University of Applied Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group (BreLax)
BreLax: midwife-led antenatal education class
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.
Active Comparator: Control group (Standard care)
Midwife-led antenatal education class
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
13 weeks till 37 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Childbirth experience
Time Frame: 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.
within 4 weeks after birth
pain management
Time Frame: 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)
within 4 weeks after birth
birthing position
Time Frame: 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
within 4 weeks after birth
Duration of labour
Time Frame: within 4 weeks after birth
Documented during labour and birth (medical birth record)
within 4 weeks after birth
Bonding
Time Frame: within 4 weeks after birth
Documented during labour and birth (medical birth record). Direct skin contact after birth (Bonding) yes/no
within 4 weeks after birth
5-minute Apgar-Score
Time Frame: 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.
within 4 weeks after birth
arterial umbilical cord pH
Time Frame: 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.
within 4 weeks after birth
Feasibility and effectiveness BreLax
Time Frame: 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.
13 weeks of pregnancy till 4 weeks after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zurich University of Applied Sciences

Collaborators

University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

March 25, 2025

Study Completion (Actual)

March 25, 2025

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023 - 000183124
  • UZH (Other Identifier: University of Zurich)
  • ZHAW (Other Identifier: Zurich University of Applied Sciences)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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