BreLax: Effectiveness of a Breathing and Relaxation Technique in Antenatal Education

Sponsor
Zurich University of Applied Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06003946
Collaborator
University of Zurich (Other)
58
1
2
16
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: BreLax: Antenatal education class
  • Behavioral: Standard care (control)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effectiveness of a Breathing and Relaxation Technique in Antenatal Education (BreLax Study): a Randomised Controlled Trial
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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)

  3. 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

  4. Duration of labour [within 4 weeks after birth]

    Documented during labour and birth (medical birth record)

  5. Bonding [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zurich University of Applied Sciences Winterthur Zurich Switzerland 8400

Sponsors and Collaborators

  • Zurich University of Applied Sciences
  • University of Zurich

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Vanessa Leutenegger, PhD Student, Zurich University of Applied Sciences
ClinicalTrials.gov Identifier:
NCT06003946
Other Study ID Numbers:
  • 2023 - 000183124
  • ZHAW
  • UZH
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vanessa Leutenegger, PhD Student, Zurich University of Applied Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2023