Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000011583
Ethics application status
Approved
Date submitted
1/12/2023
Date registered
10/01/2024
Date last updated
10/01/2024
Date data sharing statement initially provided
10/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of HypnoBirthing on epidural use during labour and birth
Scientific title
Does attending a HypnoBirthing perinatal education course reduce the use of epidurals during labour and birth?
Secondary ID [1] 310064 0
None
Universal Trial Number (UTN)
Trial acronym
HypnotiSt
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Labour pain 330602 0
Condition category
Condition code
Reproductive Health and Childbirth 327440 327440 0 0
Childbirth and postnatal care
Alternative and Complementary Medicine 327441 327441 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Attendance at a private or hospital provided HypnoBirthing course during the antenatal period. Enrollment in a HypnoBirthing course is a per-requisite for participation in the study. The HypnoBirthing courses are not provided as part of the study, Birthing women, persons or couples can attend a HypnoBirthing course with a provider of their choice without participating in the study. The HypnoBirthing courses are delivered by trained HypnoBirthing Educators accredited by the Australian HypnoBirthing Steering Committee.
These courses typically run over five sessions, usually commencing after 20 weeks gestation, with practice continued until labour and birth. The courses typically cover topics such as physiology of labour and birth, HypnoBirthing language relaxation and breathing techniques, hypnosis and visualisation techniques, massage and role of the birth partner.
Participation involves the birthing woman, person and their partners completing a series of demographic and validated psychometric surveys over the course of the HypnoBirthing program, up until and following the birth. Specifically
Study demographic survey (designed for study) (5 minutes to complete)
State - Trait Anxiety Index (10 minutes to complete)
Wijma Delivery Expectancy/Experience Questionnaire (A - pre birth & B post birth) (15 minutes to complete)
Childbirth Self-Efficacy Inventory (Birthing women / persons) (20 minutes to complete)
Two-weekly HypnoBirthing practise questionnaire (designed for study) (5 minutes to complete)
Birth Satisfaction Scale – Revised (5 minutes to complete)
Post birth Questionnaire (designed for study) (10 minutes to complete).
A selection of participants will be invited to participate in qualitative interviews prior to attending the HypnoBirthing course and following birth.
Pregnancy, labour and birth data also will also be collected on each participant from the Perinatal Dataset Collection in the state in which they gave birth.
Intervention code [1] 326471 0
Diagnosis / Prognosis
Comparator / control treatment
The comparator population will be derived from the Mater Mothers' Hospital Matrix perinatal database from March 2024 to December 2025 and matched with participants in the exposure group using propensity score matching
Control group
Historical

Outcomes
Primary outcome [1] 335301 0
The proportion of participants using neuraxial analgesia (epidural and/or spinal) for labour pain management derived from linked perinatal data collections
Timepoint [1] 335301 0
At birth
Secondary outcome [1] 423826 0
Other pharmacological analgesia use assessed through data linkage to perinatal records
Timepoint [1] 423826 0
at birth
Secondary outcome [2] 423836 0
Non-pharmacological analgesia use prior to and after randomisation (water immersion, shower, mobility, massage, birthball, hypnobirthing) assessed through data linkage to perinatal records or via participant survey designed for the study (this data is not collected in all states)
Timepoint [2] 423836 0
at birth
Secondary outcome [3] 423837 0
Duration of active first stage labour from 4cm to 10cm cervical dilation assessed through data linkage to perinatal records
Timepoint [3] 423837 0
at birth
Secondary outcome [4] 423838 0
Duration of second stage labour from 10cm to birth of infant assessed through data linkage to perinatal records
Timepoint [4] 423838 0
at birth
Secondary outcome [5] 423839 0
Proportion of women experiencing an unassisted vaginal birth assessed through data linkage to perinatal records
Timepoint [5] 423839 0
at birth
Secondary outcome [6] 423840 0
Proportion of women experiencing an assisted vaginal birth assessed through data linkage to perinatal records
Timepoint [6] 423840 0
at birth
Secondary outcome [7] 423841 0
Proportion of women experiencing caesarean section birth assessed through data linkage to perinatal records
Timepoint [7] 423841 0
at birth
Secondary outcome [8] 423842 0
Proportion of women experiencing an augmentation of labour assessed through data linkage to perinatal records
Timepoint [8] 423842 0
at birth
Secondary outcome [9] 423843 0
Estimated blood loss at birth in milliltres assessed through data linkage to perinatal records
Timepoint [9] 423843 0
at birth
Secondary outcome [10] 423844 0
Neonatal Apgar score
Timepoint [10] 423844 0
one minute post birth
Secondary outcome [11] 423845 0
Neonatal Apgar score
Timepoint [11] 423845 0
5 minutes post birth
Secondary outcome [12] 423846 0
Proportion of infants experiencing resuscitation (Intermittent positive pressure ventilation, CPR, medications) assessed through data linkage to perinatal records
Timepoint [12] 423846 0
at birth
Secondary outcome [13] 423847 0
Proportion of infants experiencing any Intensive Care Nursery (ICN) assessed through data linkage to perinatal records
Timepoint [13] 423847 0
at birth
Secondary outcome [14] 423848 0
Length of stay in hospital (hours) assessed through data linkage to perinatal records
Timepoint [14] 423848 0
At discharge from hospital
Secondary outcome [15] 423849 0
Proportion of women fully breastfeeding at discharge assessed through data linkage to perinatal records
Timepoint [15] 423849 0
At discharge from hospital
Secondary outcome [16] 423851 0
The Wijma Delivery Expectancy/Experience Questionnaire W-DEQ A score
Timepoint [16] 423851 0
At enrollment and upon completion of the HypnoBirthing course
Secondary outcome [17] 423852 0
The Wijma Delivery Expectancy/Experience Questionnaire W-DEQ B
Timepoint [17] 423852 0
Two weeks post birth
Secondary outcome [18] 423853 0
Childbirth Self-Efficacy Inventory (CBSEI) score
Timepoint [18] 423853 0
at enrollment and with 2 weeks post birth
Secondary outcome [19] 423854 0
HypnoBirthing practice compliance questionnaire
Timepoint [19] 423854 0
every 2 weeks from enrollment to birth
Secondary outcome [20] 423855 0
Birth Satisfaction scale revised
Timepoint [20] 423855 0
Within 2 weeks post birth
Secondary outcome [21] 429894 0
Proportion of infants experiencing any Special Care Nursery (SCN) admission assessed through data linkage to perinatal records
Timepoint [21] 429894 0
At birth
Secondary outcome [22] 430474 0
Participant expectations/experience as provided by interview
Timepoint [22] 430474 0
Prior to commencing HypnoBirthing course
Secondary outcome [23] 430475 0
participant expectations/experience as provided by interview
Timepoint [23] 430475 0
Within two months following birth

Eligibility
Key inclusion criteria
Reside at an address within an Qld N.S.W, Vic or W.A.
Attend a private or hospital provided HypnoBirthing program
Command of English language sufficient to follow written instructions and complete questionnaires

Comparator group
Labour commenced either spontaneously or by induction of labour (Did not undergo a planned caesarean section)
Pregnancy resulted in a live birth
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Planning an elective caesarean section birth
Planning to give birth overseas
Unable to provide individual consent

Comparator group exclusion
Underwent a planned caesarean section
Stillbirth

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Simple descriptive statistics will be used to describe the demographic profiles, labour and birth outcomes. These will be reported as frequencies and percentages and assessed for any significant differences between. Survey instruments will be scored and analysed based on the recommended approach for each instrument. The propensity score (PS) matching process involved estimating a score for each participant and then using that score to construct two equally sized cohorts with comparable characteristics. A logit model will be used to calculate a PS for each birth. The births will be matched on a one-to-one basis without replacement using calipers of width equal to 0.2 of the standard deviation of the logit of the PS (caliper equals 0.16). Comparability of baseline characteristics in the matched groups will be assessed by calculating standardized differences for each covariate to measure the bias between cohorts. Similar to an effect size, standardised difference is unaffected by sample size and a recommended method for assessing the balance of the included covariates. If the absolute value of the standardized difference is less than 10%, then the matched cohorts can be considered to be sufficiently balanced with respect to the variables being assessed. Conditional logistic regressions will be used for matched sample to accommodate the 1 to 1 matching. Odds ratios will be calculated for variables of interest. The level of significance is 0.05. Imputation will be applied for missing data where appropriate and/or stated within the analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
19/12/2025
Actual
Date of last data collection
Anticipated
23/06/2026
Actual
Sample size
Target
410
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 25454 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 41243 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 314230 0
Government body
Name [1] 314230 0
NHMRC
Country [1] 314230 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia, Queensland 4072
Country
Australia
Secondary sponsor category [1] 316164 0
None
Name [1] 316164 0
Address [1] 316164 0
Country [1] 316164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313352 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 313352 0
100 Angus Smith Dr, Douglas QLD 4814
Ethics committee country [1] 313352 0
Australia
Date submitted for ethics approval [1] 313352 0
05/10/2023
Approval date [1] 313352 0
31/10/2023
Ethics approval number [1] 313352 0
HREC/2023/QTHS/97533

Summary
Brief summary
This study will adopt a multi methods approach to assess the effect of the HypnoBirthing program (Mongan Method) on analgesia use during labour and the birth experience. Data sources will consist of routinely collected clinical data from perinatal datasets, validated psychometric surveys, questionnaires and individual participant interviews. Clinical outcomes will be compared to a control population of birthing women using propensity matching of demographic, clinical and potentially confounding variables.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127846 0
Dr Nigel Lee
Address 127846 0
School of Nursing, Midwifery and Social WorkLevel 3 Chamberlain Building University of QueenslandSt Lucia4072
Country 127846 0
Australia
Phone 127846 0
+61 0427231390
Fax 127846 0
Email 127846 0
[email protected]
Contact person for public queries
Name 127847 0
Nigel Lee
Address 127847 0
School of Nursing, Midwifery and Social WorkLevel 3 Chamberlain Building University of QueenslandSt Lucia4072
Country 127847 0
Australia
Phone 127847 0
+61 0427231390
Fax 127847 0
Email 127847 0
[email protected]
Contact person for scientific queries
Name 127848 0
Nigel Lee
Address 127848 0
School of Nursing, Midwifery and Social WorkLevel 3 Chamberlain Building University of QueenslandSt Lucia4072
Country 127848 0
Australia
Phone 127848 0
+61 0427231390
Fax 127848 0
Email 127848 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data of published results only
When will data be available (start and end dates)?
12 months following final publication, no end date
Available to whom?
Avaible to research teams that provide a HREC approved protocol and data sharing agreement
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
Contact Prinicipal Investigator via email ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.