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

Primary Purpose

Pregnancy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
BreLax: Antenatal education class
Standard care (control)
Sponsored by
Zurich University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring breathing technique, birth preparation, prenatal education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Zurich University of Applied Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group (BreLax)

Control group (Standard care)

Arm Description

BreLax: midwife-led antenatal education class

Midwife-led antenatal education class

Outcomes

Primary Outcome Measures

Self-efficacy
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

Childbirth experience
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
epidural anesthesia (PDA) yes/no, nitrous oxide yes/no, Patient Controlled Analgesia (PCA) yes/no, other pain medication yes/no (medical birth record)
birthing position
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
Duration of labour
Documented during labour and birth (medical birth record)
Bonding
Documented during labour and birth (medical birth record). Direct skin contact after birth (Bonding) yes/no
5-minute Apgar-Score
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.
arterial umbilical cord pH
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.
Feasibility and effectiveness BreLax
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.

Full Information

First Posted
July 27, 2023
Last Updated
August 15, 2023
Sponsor
Zurich University of Applied Sciences
Collaborators
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT06003946
Brief Title
Effectiveness of a Breathing and Relaxation Technique in Antenatal Education
Acronym
BreLax
Official Title
Effectiveness of a Breathing and Relaxation Technique in Antenatal Education (BreLax Study): a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zurich University of Applied Sciences
Collaborators
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
breathing technique, birth preparation, prenatal education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (BreLax)
Arm Type
Experimental
Arm Description
BreLax: midwife-led antenatal education class
Arm Title
Control group (Standard care)
Arm Type
Active Comparator
Arm Description
Midwife-led antenatal education class
Intervention Type
Behavioral
Intervention Name(s)
BreLax: Antenatal education class
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard care (control)
Intervention Description
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 Outcome Measure Information:
Title
Self-efficacy
Description
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.
Time Frame
13 weeks till 37 weeks of pregnancy
Secondary Outcome Measure Information:
Title
Childbirth experience
Description
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.
Time Frame
within 4 weeks after birth
Title
pain management
Description
epidural anesthesia (PDA) yes/no, nitrous oxide yes/no, Patient Controlled Analgesia (PCA) yes/no, other pain medication yes/no (medical birth record)
Time Frame
within 4 weeks after birth
Title
birthing position
Description
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
Time Frame
within 4 weeks after birth
Title
Duration of labour
Description
Documented during labour and birth (medical birth record)
Time Frame
within 4 weeks after birth
Title
Bonding
Description
Documented during labour and birth (medical birth record). Direct skin contact after birth (Bonding) yes/no
Time Frame
within 4 weeks after birth
Title
5-minute Apgar-Score
Description
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.
Time Frame
within 4 weeks after birth
Title
arterial umbilical cord pH
Description
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.
Time Frame
within 4 weeks after birth
Title
Feasibility and effectiveness BreLax
Description
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.
Time Frame
13 weeks of pregnancy till 4 weeks after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Leutenegger, RM, MScN
Phone
+41589344369
Email
vanessa.leutenegger@zhaw.ch
Facility Information:
Facility Name
Zurich University of Applied Sciences
City
Winterthur
State/Province
Zurich
ZIP/Postal Code
8400
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Leutenegger, RM, MScN, PhD Student
Phone
+41589344369
Email
vanessa.leutenegger@zhaw.ch
First Name & Middle Initial & Last Name & Degree
Vanessa Leutenegger, RM, MScN, PhD Student

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35581951
Citation
Shand AW, Lewis-Jones B, Nielsen T, Svensson J, Lainchbury A, Henry A, Nassar N. Birth outcomes by type of attendance at antenatal education: An observational study. Aust N Z J Obstet Gynaecol. 2022 Dec;62(6):859-867. doi: 10.1111/ajo.13541. Epub 2022 May 17.
Results Reference
background
PubMed Identifier
23121002
Citation
Rouhe H, Salmela-Aro K, Toivanen R, Tokola M, Halmesmaki E, Saisto T. Obstetric outcome after intervention for severe fear of childbirth in nulliparous women - randomised trial. BJOG. 2013 Jan;120(1):75-84. doi: 10.1111/1471-0528.12011. Epub 2012 Nov 2.
Results Reference
background
PubMed Identifier
17459542
Citation
Svensson J, Barclay L, Cooke M. Randomised-controlled trial of two antenatal education programmes. Midwifery. 2009 Apr;25(2):114-25. doi: 10.1016/j.midw.2006.12.012. Epub 2007 Apr 24.
Results Reference
background
PubMed Identifier
19436529
Citation
Svensson J, Barclay L, Cooke M. Effective antenatal education: strategies recommended by expectant and new parents. J Perinat Educ. 2008 Fall;17(4):33-42. doi: 10.1624/105812408X364152.
Results Reference
background
PubMed Identifier
19583645
Citation
Ip WY, Tang CS, Goggins WB. An educational intervention to improve women's ability to cope with childbirth. J Clin Nurs. 2009 Aug;18(15):2125-35. doi: 10.1111/j.1365-2702.2008.02720.x.
Results Reference
background
PubMed Identifier
23277726
Citation
Ahlden I, Ahlehagen S, Dahlgren LO, Josefsson A. Parents' expectations about participating in antenatal parenthood education classes. J Perinat Educ. 2012 Winter;21(1):11-7. doi: 10.1891/1058-1243.21.1.11.
Results Reference
background
PubMed Identifier
26378776
Citation
Schmidt G, Stoll K, Jager B, Gross MM. [German Version of the Childbirth Self-Efficacy Inventory and its Short Form]. Z Geburtshilfe Neonatol. 2016 Feb;220(1):28-34. doi: 10.1055/s-0035-1547296. Epub 2015 Sep 17. German.
Results Reference
background

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Effectiveness of a Breathing and Relaxation Technique in Antenatal Education

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