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Completed

NCT Number: NCT02899806

Impact of a Video Explaining Epidural Analgesia in Obstetrics

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.

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Key information

Conditions

Difficulty Processing Information Anxiety Disorders Behavior Mental Disorders Personal Satisfaction

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Intercommunal

Créteil, 94010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Written information

Other

A written information on peridural anesthesia is delivered

Video Information

Other

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

Primary outcomes

  1. Satisfaction evaluated by numerical scale from 0 to 10

    Time frame: during the 48 hour after delivery

Secondary outcomes

  1. Comprehension was evaluated by by multiple choice questions with a final score of 10

    Time frame: during the 48 hour after delivery

  2. Anxiety was evaluated by numerical scale from 0 to 10

    Time frame: during the 48 hour after delivery

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study title

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

Acronym: VIDEOCLIP

Important dates

Study start
2015
Primary completion
2015
Study completion
2017
First posted
Sep 14, 2016
Registry last updated
Jul 16, 2020

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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