Changes in Pain Level With the Use of the Regulated Expiratory Method.

March 15, 2021 updated by: Kaouther Dimassi, University Tunis El Manar

Changes in Pain Level With the Use of the Regulated Expiratory Method During Childbirth Process .

Historically, pain management during childbirth has been a primary concern in the obstetric community. In recent decades, childbirth care providers have been witnessing, especially in developed countries, a real revolution in terms of approaches around this unique moment of birth. This is how perinatal professionals are no longer concerned only with medical follow-up and the smooth running of pregnancy or the well-being of the newborn, but also with overall support for women by promoting their active participation in the childbirth process. To this end, several methods of pain management are offered to women during labor. The more documented are: locoregional (epidural) anesthesia and acupuncture. These two methods are rarely available in Tunisian public maternity hospitals where 80% of deliveries are managed. In addition, Childbirth training workshops, psychoeducation and psychosocial couple-based programs are not available in tunisian public maternities. For example, only one public structure offers a painless delivery program at Farhat Hached Sousse hospital.

In consequence, women arriving at the labor room, are largely unaware of the basic principles of childbirth process. They do not know how to manage their pain.

the application of the GUILLARME® method during labor is based on the use of a flow regulating device (Winner Flow + URO-MG®). By regulating the flow of breath during a uterine contraction, it allows better pain management. Despite a positive feedback not only from parturients but also from midwives who practiced this method, actually investigators have only subjective evaluation with no real measurable and objective impact on pain levels during childbirth process. Consequently, investigators are conducting this scientific study whose main objective is:

-To evaluate changes in pain level with the use of regulated expiratory method during childbirth process.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Historically, pain management during childbirth has been a primary concern in the obstetric community. In recent decades,childbirth care providers have been witnessing, especially in developed countries, a real revolution in terms of approaches around this unique moment of birth. This is how perinatal professionals are no longer concerned only with medical follow-up and the smooth running of pregnancy or the well-being of the newborn, but also with overall support for women by promoting their active participation in the childbirth process. To this end, several methods of pain management are offered to women during labor. The more documented are: locoregional (epidural) anesthesia and acupuncture. These two methods are rarely available in Tunisian public maternity hospitals where 80% of deliveries are managed. In addition, Childbirth training workshops, psychoeducation and psychosocial couple-based programs are not available in tunisian public maternities. For example, only one public structure offers a painless delivery program at Farhat Hached Sousse hospital.

In consequence, women arriving at the labor room, are largely unaware of the basic principles of childbirth process. They do not know how to manage their pain.

In order to overcome this situation, we introduced the GUILLARME® method to the obstetric care unit at Mongi Slim la Marsa hospital in January 2018. This method was originally a postpartum abdomino-perineal rehabilitation technique. It allows a functional abdominal rehabilitation by combining a regulated breath in a specific mouthpiece and an abdominal stimulation triggered by this same breath. The use of this method was extended to labor and childbirth. In fact, the application of the GUILLARME® method during labor is based on the use of a flow regulating device (Winner Flow + URO-MG®). By regulating the flow of breath during a uterine contraction, it allows better pain management. Despite a positive feedback not only from parturients but also from midwives who practiced this method, actually investigators have only subjective evaluation with no real measurable and objective impact on pain levels during childbirth process. Consequently, investigators are conducting this scientific study whose main objective is:

-To evaluate changes in pain level with the use of regulated expiratory method during childbirth process.

Study Type

Interventional

Enrollment (Actual)

30

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

  • Tunisia
    • Tunis
      • La Marsa, Tunis, Tunisia, 2045
        • Mongi Slim University Hospital

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 to 48 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women with a Gestational age of at least 30 weeks of amenorrhea
  • women with a Normal fetal heart rate before inclusion.
  • women having regular uterine contraction before inclusion .

Exclusion Criteria:

  • Refusal of participation
  • Women requiring epidural anesthesia
  • Women in an advanced stage of labor with a cervical dilation upon admission over 3 cm
  • A medical contraindication to vaginal delivery .
  • Intra uterine fetal demise.
  • Previous participation to childbirth training workshops
  • Women without regular uterine contraction .
  • Gestational term <30 weeks
  • fetal heart rate abnormalities

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: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: pain level changes according to the use of the Winner flow

each included patient will experience :

  • a period of consecutive spontaneous uterine contractions without using the regulated expiration mouthpiece
  • a period of consecutive uterine contractions managed by the regulated expiration method using the Winner flow
Other: Regulated expiratory method
This method was originally a postpartum abdomino-perineal rehabilitation technique. It allows a functional abdominal rehabilitation by combining a regulated breath in a specific mouthpiece and an abdominal stimulation triggered by this same breath. The use of this method was extended to labor and childbirth. In fact, the application of the method during labor is based on the use of a flow regulating device (Winner Flow + URO-MG®). By regulating the flow of breath during a uterine contraction, it allows better pain management.
Other Names:
  • Winner flow Pro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analgesia nociception index
Time Frame: 60 minutes for each participant

continuously measured by a monitor during the hole childbirth process. investigators will compare measured indexes during the two periods ( with intervention and without intervention.

An index value close to 100 corresponds to a prominent parasympathetic tone (low stress level, analgesia) and a value close to 0 corresponds to a prominent sympathetic tone (high stress level, nociception). In parturients during labor or postoperative awake patients in the recovery room, a negative linear relationship between analgesia nociception index and pain scores is documented.
60 minutes for each participant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's pain management experience
Time Frame: up to 12 hours In deed , For each recruited patient this outcome will be measured in minutes between onset of labor and delivery

a questionnair Patient's pain management experience according to the use or no use of the expiration mouthpiece during childbirth process .

estimation of Patient's pain management experience according to the use or no use of the expiration mouthpiece during childbirth process .

Patient's pain management experience according to the use or no use of the expiration mouthpiece during childbirth process .

estimation of patient's pain management experience according to the use or no use of the expiration mouthpiece during childbirth process using a questionnair
up to 12 hours In deed , For each recruited patient this outcome will be measured in minutes between onset of labor and delivery

Collaborators and Investigators

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

Sponsor

University Tunis El Manar

Investigators

  • Principal Investigator: kaouther dimassi, MD, university tunis el manar , faculty of medicine Tunis, TUNISIA

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)

April 1, 2020

Primary Completion (ACTUAL)

February 28, 2021

Study Completion (ACTUAL)

March 15, 2021

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (ACTUAL)

March 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Doloris-Winner-flow-URO-MG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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