Changes in Pain Level With the Use of the Regulated Expiratory Method.
Condition: Childbirth Process
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Regulated expiratory method
Intervention type(s): Other
Intervention description(s): 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 intervention name(s): Winner flow Pro
Intervention model: Single Group Assignment
Intervention model description: Each participant will experience successives periods A period of 4 consecutive contractions without using the expiration mouthpiece and a second period of 4 consecutive contractions using the the expiration mouthpiece .
pain levels measured in each period will be compared for the same participant
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pain; childbirth; delivery; expiration; exercise; mothers