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

NCT04302090 | Completed

• 1 other identifier: Doloris-Winner-flow-URO-MG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Childbirth Process

Keywords

pain; childbirth; delivery; expiration; exercise; mothers

Outcome Measures

Primary Outcomes (1)

• analgesia nociception index

  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 Outcomes (1)

• Patient's pain management experience

  up to 12 hours In deed , For each recruited patient this outcome will be measured in minutes between onset of labor and delivery

Study Arms (1)

pain level changes according to the use of the Winner flow

EXPERIMENTAL

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

Interventions

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.

Also known as: Winner flow Pro

pain level changes according to the use of the Winner flow

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women with a Gestational age of at least 30 weeks of amenorrhea

You may not qualify if:

• 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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Mongi Slim University Hospital

La Marsa, Tunis Governorate, 2045, Tunisia

Location

MeSH Terms

Conditions

Pain; Death; Motor Activity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Behavior

Study Officials

• kaouther dimassi, MD

  university tunis el manar , faculty of medicine Tunis, TUNISIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor obstetrics and gynecology faculty of medicine Tunis

Model Details: 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

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 10, 2020
• Study Start: April 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: March 15, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)