Breech Presentation at TermNCT01564004
Clinical Hypnosis Before External Cephalic Version (ECV)
A study testing Clinical hypnosis or neuro-linguistic programming in people with Breech Presentation at Term, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
Does clinical hypnosis or neuro-linguistic programming improve the success rate of external cephalic version? Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breech Presentation at Term
- What is being tested?
- Clinical hypnosis or neuro-linguistic programming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 716 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Sep 2014
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- singleton
- breech presentation
- gestation age above 36 weeks + 6 days
Who cannot join
- multiples
- cannot understand German language
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of obstetrics and gynaecology, Johann Wolfgang Goethe University
Frankfurt am Main, Hesse, 50690
Joscha Reinhard, Priv.-Doz. Dr. MBBS BSc(Hon), +49-(0)-157 76400061, Joscha.Reinhard@kgu.de
About this study
Official title: Clinical Hypnosis Versus Neuro-linguistic Programming Before External Cephalic Version (ECV) - a Prospective Off-centre Randomised Controlled Trial
Does clinical hypnosis or neuro-linguistic programming improve the success rate of external cephalic version?
Read the detailed description
Prospective off-center randomisation of clinical hypnosis or neuro-linguistic programming intervention prior to a external cephalic version treatment.
- Conditions
- Breech Presentation at Term
- Being tested
- Clinical hypnosis or neuro-linguistic programming
- Keywords
- breech presentation at term, pregnancy, external cephalic version (ECV), clinical hypnosis, neuro-linguistic programming (NLP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical hypnosis or neuro-linguistic programmingOther
20 minutes tape recording intervention
| Study group | Role | What they receive |
|---|---|---|
| Clinical hypnosis | Experimental | 20 minutes tape recorded clinical hypnosis intervention Receives: Other: Clinical hypnosis or neuro-linguistic programming |
| Neuro-linguistic programming | Active comparator | 20 minutes tape recording of nouro-linguistic programming intervention Receives: Other: Clinical hypnosis or neuro-linguistic programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful ECV
Rate of cephalic presentation three hours after external cephalic version.
Measured: 3 hours after ECV treatment
Secondary outcomes (1)
Questionnaire
Measured: before and 30 minutes after ECV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startFeb 2011
- Primary completionFeb 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breech Presentation at TermStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 716 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. med. Joscha Reinhard, MBBS BSc(Hon), Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564004
- Sponsor's protocol ID
- 12/11
- Status last verified
- Mar 2012
- First submitted
- 24 Mar 2012
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Hypnosis Versus Neuro-linguistic Programming Before External Cephalic Version (ECV) - a Prospective Off-centre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01564004
- Acronym / sponsor ID
- 12/11
- Conditions
- Breech Presentation at Term
- Keywords
- breech presentation at term, pregnancy, external cephalic version (ECV), clinical hypnosis, neuro-linguistic programming (NLP)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 716 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 27 Mar 2012 (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.
Does clinical hypnosis or neuro-linguistic programming improve the success rate of external cephalic version?
Detailed description
Prospective off-center randomisation of clinical hypnosis or neuro-linguistic programming intervention prior to a external cephalic version treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical hypnosis | Experimental | Other: Clinical hypnosis or neuro-linguistic programming20 minutes tape recorded clinical hypnosis intervention |
| Neuro-linguistic programming | Active comparator | Other: Clinical hypnosis or neuro-linguistic programming20 minutes tape recording of nouro-linguistic programming intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- singleton
- breech presentation
- gestation age above 36 weeks + 6 days
Key exclusion criteria (2 listed)
- multiples
- cannot understand German language
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 |
|---|---|---|
| Clinical hypnosis or neuro-linguistic programming20 minutes tape recording intervention | Other | Clinical hypnosis, Neuro-linguistic programming |
Primary outcome
Successful ECV
Time frame: 3 hours after ECV treatment
Rate of cephalic presentation three hours after external cephalic version.
1 secondary outcome
Questionnaire
Time frame: before and 30 minutes after ECV
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
Related trials for Breech Presentation at Term
Not yet recruitingObservational study
Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation
Breech Fetal Presentation, Breech Presentation of Fetus with Successful Version
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.
Department of obstetrics and gynaecology, Johann Wolfgang Goethe University
Frankfurt am Main, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical hypnosis or neuro-linguistic programming in people with Breech Presentation at Term, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Mar 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 Germany. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful ECV (time frame: 3 hours after ECV treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2012.