NCT02899494

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2016

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

4.1 years

First QC Date

September 9, 2016

Last Update Submit

August 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Childbirth Perception Questionnaire (CPQ) score

    French adaptation of CPQ score

    5 months

Study Arms (2)

Group A

OTHER

Antenatal classes

Other: Antenatal classes

Group B

EXPERIMENTAL

Physical and psychic preparation

Other: Physical and psychic preparation

Interventions

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maternité Catherine BARET de Pertuis

Pertuis, 84123, France

Location

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Interventions

Prenatal EducationRestraint, Physical

Intervention Hierarchy (Ancestors)

Patient Education as TopicHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesBehavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Jean-Marc AYOUBI, PhD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 14, 2016

Study Start

October 1, 2012

Primary Completion

November 7, 2016

Study Completion

November 7, 2016

Last Updated

August 15, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations