Effects of an Educational Tool on Knowledge and Risk Retention About Epidural Analgesia in Parturients.

NCT05355103 | Unknown DMC

• 1 other identifier: 2021-3575: Epid_Consent
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study if to assess the basic knowledge of parturients about epidural analgesia, including an assessment of risks and benefits, but also risks associated with the procedure, and the impact of giving an informative document, in addition to usual consent counseling, on retention of risks. A questionnaire was build by Delphi method by an expert panel in anesthesia. The questionnaire was answered on the first postpartum day by a group of patient that received the usual consent in the investigators's institution, including a standard explanation of risks and benefits at the moment they receive the epidural analgesia. Parallel to the recruiting of the first group of patient receiving standard information and consent, an educational tool was build to provide informations relative to the epidural, including informations about the technique, the functioning of the epidural, the risks and benefits. A second group of patient, who will received the educational tool antepartum at the time of admission to hospital for their delivery, will answer the same questionnaire on post-partum day 1. The results will then be compared to determine if the educational tool can improve the knowledge about epidural and so lead to a better consent about the epidural technique. Comments about the educational tool and suggestions for improvement will also be collected.

Conditions

Analgesia, Epidural

Outcome Measures

Primary Outcomes (1)

• Knowledge and risk retention about epidural analgesia

  Assessment of knowledge and risk retention about epidural analgesia. A questionnaire was build using Delphi method by an expert panel composed of anesthesiologists and Obstetric anesthesiologists. The final score of this questionnaire is the measurement tool for the primary outcome and is a dependant variable. * Score will be determined by the number of right answers a patient has on a scale of 0 to 12 (12 questions) * A patient gets 1 point for every right answer * The scale is based on the number of questions in the questionnaire and is not validated in the literature Since the two groups are independent, a T-test will be used if the data are normal. If not, a Mann-Whitney test will be used. Multivariates analysis by linear regression will be done for the variables above to consider possible confounding factors: * Previous epidural analgesia * Pain at the moment of the epidural technique * Satisfaction about the information received about epidural analgesia

  Post-partum day 1

Study Arms (2)

Control Group

NO INTERVENTION

Women having received epidural analgesia after a standard verbal consent provided by the anesthesiologist before doing the epidural technique, representing the standard of practice in our institution

Exposed group

ACTIVE COMPARATOR

Woman having received epidural analgesia after having received and read an educational tool at her admission to labour and delivery unit, in addition to the standard verbal consent.

Other: Educational tool about epidural analgesia

Interventions

Educational tool about epidural analgesia OTHER

See arm description

Exposed group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant woman
• Age over 18 years old
• Had epidural analgesia during labour

You may not qualify if:

• Medical condition having influence on the risks of receiving epidural analgesia
• Insufficient understanding of french language
• Inability to provide medical consent
• Diagnosed and documented intellectual limitation
• Epidural anesthesia being converted to general anesthesia for a urgent cesarean section
• Refusal to participate

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marie-Chantal Dubois, MD

CONTACT

819-346-1110; marie-chantal.dubois@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor of anesthesiology

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 2, 2022
• Study Start: June 15, 2021
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

CA (1)