NCT02899806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2017

Enrollment Period

1 month

First QC Date

August 30, 2016

Last Update Submit

July 15, 2020

Conditions

Keywords

Video InformationSatisfactionAnxietyEpidural AnalgesiaComprehensiondelivery

Outcome Measures

Primary Outcomes (1)

  • Satisfaction evaluated by numerical scale from 0 to 10

    during the 48 hour after delivery

Secondary Outcomes (2)

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

    during the 48 hour after delivery

  • Anxiety was evaluated by numerical scale from 0 to 10

    during the 48 hour after delivery

Study Arms (2)

Paper

PLACEBO COMPARATOR

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

Other: Written Information

Video

EXPERIMENTAL

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

Other: Written InformationOther: Video Information

Interventions

A written information on peridural anesthesia is delivered

PaperVideo

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

Video

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal

Créteil, 94010, France

Location

MeSH Terms

Conditions

Personal SatisfactionAnxiety Disorders

Condition Hierarchy (Ancestors)

BehaviorMental Disorders

Study Officials

  • Marion ANDREOLETTI, MD

    CHI de Créteil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 14, 2016

Study Start

September 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2017

Last Updated

July 16, 2020

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations