Impact of a Video Explaining Epidural Analgesia in Obstetrics

NCT ID: NCT02899806

Last Updated: 2020-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-10-31

Brief Summary

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The aim of this study was to investigate the impact of multimedia information on epidural anesthesia. Pregnant women were randomly assessed to get a video information in addition to an oral and written information on epidural anesthesia. Maternal satisfaction concerning the quality of the information as well their anxiety and understanding of the procedure were assessed and compared in both groups.

Detailed Description

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The information in anesthesia consultation is mandatory. Few studies have investigated the impact of multimedia preoperative information in terms of satisfaction, comprehension and anxiety, with conflicting results. None have evaluated the contribution of a video explaining epidural analgesia in obstetrics. This study compared two types of information given in anesthesia consultation: an oral and written information (group P) versus oral, written and video information (group V). The main objective was maternal satisfaction, the secondary objectives were understanding and anxiety.

This is a common care, prospective and randomized study, conducted between September 2015 and February 2016 in the Creteil Intercommunal Hospital Center (CHIC) and accepted by the ethics committee Paris V. After information, not opposition of women who accepted to participated was collected. Oral information on epidural analgesia was provided in consultation by the anesthesiologist, with delivery of a written information sheet. The video made at CHIC in 2015, was transmitted, in addition, by email to patients randomized in the group V for she could look it at their convenience. Satisfaction and anxiety were evaluated by numerical scale from 0 to 10 and comprehension by multiple choice questions with a final score of 10. These three criteria were also evaluated in an emergency context in which women received oral and written information (group U). Evaluation questionnaires were given during the anesthesia consultation and recovered during the hospitalization after childbirth.

Conditions

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Difficulty Processing Information

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Paper

Information about epidural analgesia by oral and paper sheep given by anesthesist in programed consultation

Group Type PLACEBO_COMPARATOR

Written Information

Intervention Type OTHER

A written information on peridural anesthesia is delivered

Video

Video information in addition to oral and written information gave by anesthesist in programed consultation

Group Type EXPERIMENTAL

Written Information

Intervention Type OTHER

A written information on peridural anesthesia is delivered

Video Information

Intervention Type OTHER

A link to a video explaining peridural anesthesia is delivered to the pregnant woman. The patient can watch the video several times.

Interventions

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Written Information

A written information on peridural anesthesia is delivered

Intervention Type OTHER

Video Information

A link to a video explaining peridural anesthesia is delivered to the pregnant woman. The patient can watch the video several times.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant woman
* Affiliated to social security system
* Understanding French language
* Internet access
* \>18 years old and not subject to a measure of legal protection

Exclusion Criteria

* Contre indications to epidural
* Refusal to participate in the study
* Not affiliated with the Social Security system
* No understanding French
* No access to Internet
* Patient minor or under legal protection
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role lead

Responsible Party

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Marion ANDREOLETTI

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marion ANDREOLETTI, MD

Role: PRINCIPAL_INVESTIGATOR

CHI de Créteil

Locations

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Centre Hospitalier Intercommunal

Créteil, , France

Site Status

Countries

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France

Other Identifiers

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VIDEOCLIP

Identifier Type: -

Identifier Source: org_study_id

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