PregnancyNaitreEnchanNCT02899494
Effect of the "Adjusted Vocal Expression" Method on the Satisfaction of Parturients About Their Childbirth
A study testing Antenatal classes and Physical and psychic preparation in people with Pregnancy, run by Hopital Foch at 2 sites in France.
Trial summary
To emit voluntarily sounds mastered during the childbirth is a practice found in certain cultures of country of Africa or Muslim or gypsy traditions. Today, because of the medical coverage and because of the childbirth in a hospital environment, this tradition is not anymore transmitted. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Antenatal classes and Physical and psychic preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2012to 7 Nov 2016
- 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
- Women of more than 18 years old
- Primipara
- Patients joining the antenatal classes dispensed by the midwives.
- Patients affiliated to a national insurance scheme or benefiting from such a diet
- Patients having given a written consent form
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
France2 sites
Maternité Catherine BARET de Pertuis
Pertuis, 84123
Hopital Foch
Suresnes, 92150
About this study
Official title: Effect of the "Adjusted Vocal Expression" Method on the Satisfaction of Parturients About Their Childbirth (NaîtreEnchanté)
To emit voluntarily sounds mastered during the childbirth is a practice found in certain cultures of country of Africa or Muslim or gypsy traditions. Today, because of the medical coverage and because of the childbirth in a hospital environment, this tradition is not anymore transmitted.
The emission of a sound vibration conjugated to a positive intention managed during the childbirth was experimented with around thirty mothers. In the term of this pilot study, most of the women expressed one felt very positive towards the new method, in particular when they compared it with a previous childbirth where this method was not used.
Read more
During these childbirths, the midwives also indicated a shortening of the working time.
The present study aim essentially is to confirm the positive effect of the method on the felt of the childbirth.
- Conditions
- Pregnancy
- Being tested
- Antenatal classes, Physical and psychic preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal classesOther
Physical and psychic preparationOther
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Antenatal classes Receives: Other: Antenatal classes |
| Group B | Experimental | Physical and psychic preparation Receives: Other: Physical and psychic preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childbirth Perception Questionnaire (CPQ) score
French adaptation of CPQ score
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startOct 2012
- Primary completion7 Nov 2016
- Study completion7 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc AYOUBI, PhD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899494
- Sponsor's protocol ID
- 2012/10
- Other IDs
- 2012-A00716-37
- Acronym
- NaitreEnchan
- Status last verified
- Aug 2019
- First submitted
- 9 Sep 2016
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the "Adjusted Vocal Expression" Method on the Satisfaction of Parturients About Their Childbirth (NaîtreEnchanté)
- ClinicalTrials.gov ID
- NCT02899494
- Acronym / sponsor ID
- NaitreEnchan / 2012/10
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- 7 Nov 2016 (actual)
- Study completion
- 7 Nov 2016 (actual)
- First posted
- 14 Sep 2016 (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.
To emit voluntarily sounds mastered during the childbirth is a practice found in certain cultures of country of Africa or Muslim or gypsy traditions. Today, because of the medical coverage and because of the childbirth in a hospital environment, this tradition is not anymore transmitted.
The emission of a sound vibration conjugated to a positive intention managed during the childbirth was experimented with around thirty mothers. In the term of this pilot study, most of the women expressed one felt very positive towards the new method, in particular when they compared it with a previous childbirth where this method was not used.
During these childbirths, the midwives also indicated a shortening of the working time.
The present study aim essentially is to confirm the positive effect of the method on the felt of the childbirth.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Other: Antenatal classesAntenatal classes |
| Group B | Experimental | Other: Physical and psychic preparationPhysical and psychic preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women of more than 18 years old
- Primipara
- Patients joining the antenatal classes dispensed by the midwives.
- Patients affiliated to a national insurance scheme or benefiting from such a diet
- Patients having given a written consent form
Key exclusion criteria (1 listed)
- None
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 classes | Other | Group A |
| Physical and psychic preparation | Other | Group B |
Primary outcome
Childbirth Perception Questionnaire (CPQ) score
Time frame: 5 months
French adaptation of CPQ score
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 15 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Jean-Marc AYOUBI, PhD principal investigator
Hopital Foch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antenatal classes and Physical and psychic preparation in people with Pregnancy, run by Hopital Foch at 2 sites in France.
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 5 inclusion and 1 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 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
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?
Childbirth Perception Questionnaire (CPQ) score (time frame: 5 months). 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 15 Aug 2019.