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

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ClinicalTrials.gov Identifier: NCT02899806
Recruitment Status : Active, not recruiting
First Posted : September 14, 2016
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Marion ANDREOLETTI, Centre Hospitalier Intercommunal Creteil

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Difficulty Processing Information Other: Written Information Other: Video Information Not Applicable

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  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of a Video Explaining Epidural Analgesia in Obstetrics in Terms of Satisfaction, Understanding and Anxiety: A Prospective Randomised Trial
Study Start Date : September 2015
Actual Primary Completion Date : October 2015
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




Primary Outcome Measures :
  1. Satisfaction evaluated by numerical scale from 0 to 10 [ Time Frame: during the 48 hour after delivery ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899806


Locations
France
Centre Hospitalier Intercommunal
Creteil, France, 94010
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Investigators
Principal Investigator: Marion ANDREOLETTI, MD CHI de Créteil

Responsible Party: Marion ANDREOLETTI, Physician, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT02899806     History of Changes
Other Study ID Numbers: VIDEOCLIP
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marion ANDREOLETTI, Centre Hospitalier Intercommunal Creteil:
Video Information
Satisfaction
Anxiety
Epidural Analgesia
Comprehension
delivery