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Completed

NCT Number: NCT06003946

Effectiveness of a Breathing and Relaxation Technique in Antenatal Education

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zurich University of Applied Sciences

Winterthur, Canton of Zurich, 8400, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. 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.

  2. 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)

  3. 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

  4. Duration of labour

    Time frame: within 4 weeks after birth

    Documented during labour and birth (medical birth record)

  5. Bonding

    Time frame: within 4 weeks after birth

    Documented during labour and birth (medical birth record). Direct skin contact after birth (Bonding) yes/no

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Zurich University of Applied Sciences

Other

Collaborators

  • University of Zurich

Registry information

Official study title

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

Acronym: BreLax

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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