PregnancyPhase 2/3NCT00282204
Hypnosis Antenatal Training for Childbirth (HATCh): a Randomised Controlled Trial
A Phase 2/3 study testing antenatal hypnosis + audio compact disc on hypnosis and Audio compact disc on hypnosis in people with Pregnancy and Labor, run by Women's and Children's Hospital, Australia at 1 site in Australia.
Trial summary
Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy. Read more about this study
- Who is it for?
- Any age, women only
- What is being tested?
- antenatal hypnosis + audio compact disc on hypnosis and Audio compact disc on hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2005to Dec 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- women > 34 < 39 weeks gestation; singleton, viable fetus, vertex presentation, who are not in active labour (active labour is defined as cervical effacement and dilatation associated with regular uterine contractions) and who are planning a vaginal birth.
Who cannot join
- Previous hypnosis preparation for childbirth;
- poor understanding of English requiring translator;
- women who are already enrolled in another pregnancy trial where analgesia requirements are an outcome measure;
- active psychological or psychiatric problems such as: active depression requiring treatment by a psychiatrist;
- schizophrenia;
- prior psychosis;
- severe intellectual disability.
- Women with pain caused by specific pathological entities such as: congenital neuromuscular disorders; spina bifida; metastatic disease; osteoporosis; rheumatoid arthritis; fractures,are also excluded
Trial locations and contacts
1 site in 1 country.
Australia1 site
Women's and Children's Hospital
Adelaide, South Australia, 5006
About this study
Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy.
Read the detailed description
Background: Although medical interventions play an important role in preserving lives and maternal comfort they have become increasingly routine in normal childbirth. This may increase the risk of associated complications and a less satisfactory birth experience. Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy.
Methods / Design: A single centre, randomised controlled trial using a 3 arm parallel group design in the largest tertiary maternity unit in South Australia. Group 1 participants receive antenatal hypnosis training in preparation for childbirth administered by a qualified hypnotherapist with the use of an audio compact disc on hypnosis for re-enforcement; Group 2 consists of antenatal hypnosis training in preparation for childbirth using an audio compact disc on hypnosis administered by a nurse with no training in hypnotherapy; Group 3 participants continue with their usual preparation for childbirth with no additional intervention. Women > 34 < 39 weeks gestation, with a singleton, viable fetus, vertex presentation, who are not in active labour or planning a vaginal birth are eligible to participate. Allocation concealment is achieved using telephone randomisation. Participants assigned to hypnosis groups are trained as near as possible to 37 weeks gestation. Group allocations are concealed from treating obstetricians, anaesthetists, midwives and those personnel collecting and analysing data. Our sample size of 135 women / group gives the study 80% power to detect a clinically relevant fall of 20% in the number of women requiring pharmacological analgesia - the primary endpoint. We estimate that approximately 5-10% of women will deliver prior to receiving their allocated intervention. We plan to recruit 150 women / group and perform interim analyses when 150 and 300 participants have been recruited. All participants will be analysed according to the "Intention to treat" principle with comprehensive pre-planned cost- benefit and subgroup analyses.
Discussion: If effective, hypnosis would be a simple, inexpensive way to improve the childbirth experience, reduce complications associated with pharmacological interventions, yield cost savings in maternity care, and provide evidence to guide clinical practice.
- Being tested
- antenatal hypnosis + audio compact disc on hypnosis, Audio compact disc on hypnosis
- Keywords
- Hypnosis, Hypnotherapy, Childbirth, Analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antenatal hypnosis + audio compact disc on hypnosisBehavioural
Audio compact disc on hypnosisBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care control |
| Hypnosis + CD | Experimental | Hypnosis plus audio cd on hypnosis Receives: Behavioral: antenatal hypnosis + audio compact disc on hypnosis |
| Audio CD on Hypnosis | Active comparator | Audio CD on hypnosis sessions weekly on three occasions after 34 weeks gestation Receives: Behavioral: Audio compact disc on hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The use of pharmacological analgesia during labour and childbirth will be collected from the birth register where all analgesia is documented by the attending midwife
Measured: Within 24 hours of the birth
Secondary outcomes (13)
1. Maternal rating of the overall pain experienced during labour and childbirth
Measured: Usually within 48 hours or before discharge from hospital
2. Mode of delivery
Measured: Within 24 hours of the birth
3. Use of oxytocics
Measured: Within 24 hours of the birth
4. Postnatal depression
Measured: At 6 weeks and 6 months postnatal
5. Maternal anxiety
Measured: At 6 weeks and 6 months postnatal
6. Neonatal Apgar score at 5 minutes < 7
Measured: within 24 hours of birth
7. Maternal admission to the High Dependency Unit (HDU) or the Intensive Care Unit (ICU)
Measured: within 24 hours of birth
8. Maternal rating whether the birth experience was. Worse / better / same as expected
Measured: within 24 hours of birth
9. Maternal rating of control during the labour during the birth
Measured: within 24 hours of birth
10. Maternal rating whether the birth was rated positive or negative experience
Measured: within 24 hours of birth
11. Length of neonatal nursery stay
Measured: within 24 hours of birth
12. Length of maternal stay in hospital
Measured: within 6 months of the birth
13. Number of women breast feeding at discharge from hospital and at 6 weeks and 6 months
Measured: 6 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's and Children's Hospital, Australia
- Sponsor type
- Other government
- Investigators
- Marion I Andrew, FANZCA, Principal investigator, Women's and Children's Hospital, AustraliaAllan M Cyna, FRCA, Study director, Women's and Children's Hospital, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282204
- Sponsor's protocol ID
- ACTRN012605000018617
- Status last verified
- Dec 2010
- First submitted
- 24 Jan 2006
- Last updated
- 29 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cyna AM, Andrew MI, Robinson JS, Crowther CA, Baghurst P, Turnbull D, Wicks G, Whittle C. Hypnosis Antenatal Training for Childbirth (HATCh): a randomised controlled trial [NCT00282204]. BMC Pregnancy Childbirth. 2006 Mar 5;6:5. doi: 10.1186/1471-2393-6-5.
PubMed 16515709
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis Antenatal Training for Childbirth (HATCh): a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00282204
- Acronym / sponsor ID
- ACTRN012605000018617
- Keywords
- Hypnosis, Hypnotherapy, Childbirth, Analgesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Women's and Children's Hospital, AustraliaOther government
- Study start
- Dec 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy.
Detailed description
Background: Although medical interventions play an important role in preserving lives and maternal comfort they have become increasingly routine in normal childbirth. This may increase the risk of associated complications and a less satisfactory birth experience. Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy.
Methods / Design: A single centre, randomised controlled trial using a 3 arm parallel group design in the largest tertiary maternity unit in South Australia. Group 1 participants receive antenatal hypnosis training in preparation for childbirth administered by a qualified hypnotherapist with the use of an audio compact disc on hypnosis for re-enforcement; Group 2 consists of antenatal hypnosis training in preparation for childbirth using an audio compact disc on hypnosis administered by a nurse with no training in hypnotherapy; Group 3 participants continue with their usual preparation for childbirth with no additional intervention. Women > 34 < 39 weeks gestation, with a singleton, viable fetus, vertex presentation, who are not in active labour or planning a vaginal birth are eligible to participate. Allocation concealment is achieved using telephone randomisation. Participants assigned to hypnosis groups are trained as near as possible to 37 weeks gestation. Group allocations are concealed from treating obstetricians, anaesthetists, midwives and those personnel collecting and analysing data. Our sample size of 135 women / group gives the study 80% power to detect a clinically relevant fall of 20% in the number of women requiring pharmacological analgesia - the primary endpoint. We estimate that approximately 5-10% of women will deliver prior to receiving their allocated intervention. We plan to recruit 150 women / group and perform interim analyses when 150 and 300 participants have been recruited. All participants will be analysed according to the "Intention to treat" principle with comprehensive pre-planned cost- benefit and subgroup analyses.
Discussion: If effective, hypnosis would be a simple, inexpensive way to improve the childbirth experience, reduce complications associated with pharmacological interventions, yield cost savings in maternity care, and provide evidence to guide clinical practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care control |
| Hypnosis + CD | Experimental | Behavioral: antenatal hypnosis + audio compact disc on hypnosisHypnosis plus audio cd on hypnosis |
| Audio CD on Hypnosis | Active comparator | Behavioral: Audio compact disc on hypnosisAudio CD on hypnosis sessions weekly on three occasions after 34 weeks gestation |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- women > 34 < 39 weeks gestation; singleton, viable fetus, vertex presentation, who are not in active labour (active labour is defined as cervical effacement and dilatation associated with regular uterine contractions) and who are planning a vaginal birth.
Key exclusion criteria (8 listed)
- Previous hypnosis preparation for childbirth;
- poor understanding of English requiring translator;
- women who are already enrolled in another pregnancy trial where analgesia requirements are an outcome measure;
- active psychological or psychiatric problems such as: active depression requiring treatment by a psychiatrist;
- schizophrenia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antenatal hypnosis + audio compact disc on hypnosis | Behavioural | Hypnosis + CD |
| Audio compact disc on hypnosis | Behavioural | Audio CD on Hypnosis |
Primary outcome
The use of pharmacological analgesia during labour and childbirth will be collected from the birth register where all analgesia is documented by the attending midwife
Time frame: Within 24 hours of the birth
13 secondary outcomes
1. Maternal rating of the overall pain experienced during labour and childbirth
Time frame: Usually within 48 hours or before discharge from hospital
2. Mode of delivery
Time frame: Within 24 hours of the birth
3. Use of oxytocics
Time frame: Within 24 hours of the birth
4. Postnatal depression
Time frame: At 6 weeks and 6 months postnatal
5. Maternal anxiety
Time frame: At 6 weeks and 6 months postnatal
6. Neonatal Apgar score at 5 minutes < 7
Time frame: within 24 hours of birth
7. Maternal admission to the High Dependency Unit (HDU) or the Intensive Care Unit (ICU)
Time frame: within 24 hours of birth
8. Maternal rating whether the birth experience was. Worse / better / same as expected
Time frame: within 24 hours of birth
9. Maternal rating of control during the labour during the birth
Time frame: within 24 hours of birth
10. Maternal rating whether the birth was rated positive or negative experience
Time frame: within 24 hours of birth
11. Length of neonatal nursery stay
Time frame: within 24 hours of birth
12. Length of maternal stay in hospital
Time frame: within 6 months of the birth
13. Number of women breast feeding at discharge from hospital and at 6 weeks and 6 months
Time frame: 6 months after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2012.
- Background: PubMed 16515709Cyna AM, Andrew MI, Robinson JS, Crowther CA, Baghurst P, Turnbull D, Wicks G, Whittle C. Hypnosis Antenatal Training for Childbirth (HATCh): a randomised controlled trial [NCT00282204]. BMC Pregnancy Childbirth. 2006 Mar 5;6:5. doi: 10.1186/1471-2393-6-5.
Related trials for Pregnancy
RecruitingObservational study
Midwest Birth Outcomes and Indigenous American Pregnancy
Pregnancy
RecruitingPhase 4
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Cervical Cancer
Active, not recruiting
Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy
Pregnancy
RecruitingObservational study
Glucose Levels and Outcomes in Women - Mid Pregnancy
Pregnancy
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion I Andrew, FANZCA principal investigator
Women's and Children's Hospital, Australia
Allan M Cyna, FRCA study director
Women's and Children's Hospital, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing antenatal hypnosis + audio compact disc on hypnosis and Audio compact disc on hypnosis in people with Pregnancy and Labor, run by Women's and Children's Hospital, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The use of pharmacological analgesia during labour and childbirth will be collected from the birth register where all analgesia is documented by the attending midwife (time frame: Within 24 hours of the birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00282204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2012; AzTrials last refreshed its copy on 6 Nov 2026.