Effectiveness of a Breathing and Relaxation Technique in Antenatal Education

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Behavioral: Standard care (control)

• Registration Number: NCT06003946
• Lead Sponsor: Zurich University of Applied Sciences

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.

Study Timeline

• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-22
• Study Start: 2023-11-01
• Status Verified: 2025-03
• Primary Completion: 2025-03-25
• Study Completion: 2025-03-25
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (Standard care)	Standard care (control)	Midwife-led antenatal education class

Primary Outcome Measures

Name	Time	Method
Self-efficacy	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 Outcome Measures

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

Trial Locations

Locations (1)

Zurich University of Applied Sciences; 🇨🇭 Winterthur, Zurich, Switzerland