Clinical trial NCT04302090: Changes in Pain Level With the Use of the Regulated Expiratory Method.
Official title: Changes in Pain Level With the Use of the Regulated Expiratory Method During Childbirth Process .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childbirth Process
Keywords: pain
childbirth
delivery
expiration
exercise
mothers
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: analgesia nociception index
timeFrame: 60 minutes for each participant
Secondary outcomes:
measure: Patient's pain management experience
timeFrame: up to 12 hours In deed , For each recruited patient this outcome will be measured in minutes between onset of labor and delivery
Other outcomes:
Locations:
city: La Marsa
country: Tunisia
facility: Mongi Slim University Hospital
state: Tunis
Study officials:
affiliation: university tunis el manar , faculty of medicine Tunis, TUNISIA
name: kaouther dimassi, MD
role: PRINCIPAL_INVESTIGATOR
References: