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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04302090
Enrollment
30
Registered
2020-03-10
Start date
2020-04-01
Completion date
2021-03-15
Last updated
2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childbirth Process

Keywords

pain, childbirth, delivery, expiration, exercise, mothers

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.

Interventions

OTHERRegulated 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.

Sponsors

University Tunis El Manar
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
analgesia nociception index60 minutes for each participantcontinuously 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.

Secondary

MeasureTime frameDescription
Patient's pain management experienceup to 12 hours In deed , For each recruited patient this outcome will be measured in minutes between onset of labor and deliverya 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

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026