Impact of a Video Explaining Epidural Analgesia in Obstetrics (VIDEOCLIP)

July 15, 2020 updated by: Marion ANDREOLETTI, Centre Hospitalier Intercommunal Creteil

Impact of a Video Explaining Epidural Analgesia in Obstetrics in Terms of Satisfaction, Understanding and Anxiety: A Prospective Randomised Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94010
        • Centre Hospitalier Intercommunal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Paper
Information about epidural analgesia by oral and paper sheep given by anesthesist in programed consultation
Other: Written Information
A written information on peridural anesthesia is delivered
Experimental: Video
Video information in addition to oral and written information gave by anesthesist in programed consultation
Other: Written Information
A written information on peridural anesthesia is delivered
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Satisfaction evaluated by numerical scale from 0 to 10
Time Frame: during the 48 hour after delivery
during the 48 hour after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Comprehension was evaluated by by multiple choice questions with a final score of 10
Time Frame: during the 48 hour after delivery
during the 48 hour after delivery
Anxiety was evaluated by numerical scale from 0 to 10
Time Frame: during the 48 hour after delivery
during the 48 hour after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Investigators

  • Principal Investigator: Marion ANDREOLETTI, MD, CHI de Créteil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VIDEOCLIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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