Effect of the "Adjusted Vocal Expression" Method on the Satisfaction of Parturients About Their Childbirth (NaitreEnchan)

August 13, 2019 updated by: Hopital Foch

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pertuis, France, 84123
        • Maternité Catherine BARET de Pertuis
      • Suresnes, France, 92150
        • Hôpital FOCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A
Antenatal classes
Other: Antenatal classes
Experimental: Group B
Physical and psychic preparation
Other: Physical and psychic preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Childbirth Perception Questionnaire (CPQ) score
Time Frame: 5 months
French adaptation of CPQ score
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Jean-Marc AYOUBI, PhD, Hôpital FOCH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Actual)

November 7, 2016

Study Completion (Actual)

November 7, 2016

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2012/10
  • 2012-A00716-37 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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