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Completed

NCT Number: NCT04302090

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

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.

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Key information

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mongi Slim University Hospital

La Marsa, Tunis Governorate, 2045, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regulated expiratory method

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2020
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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