Clinical trial NCT02899806: Impact of a Video Explaining Epidural Analgesia in Obstetrics
Official title: Impact of a Video Explaining Epidural Analgesia in Obstetrics in Terms of Satisfaction, Understanding and Anxiety: A Prospective Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficulty Processing Information
Keywords: Video Information
Satisfaction
Anxiety
Epidural Analgesia
Comprehension
delivery
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 301
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Satisfaction evaluated by numerical scale from 0 to 10
timeFrame: during the 48 hour after delivery
Secondary outcomes:
measure: Comprehension was evaluated by by multiple choice questions with a final score of 10
timeFrame: during the 48 hour after delivery
measure: Anxiety was evaluated by numerical scale from 0 to 10
timeFrame: during the 48 hour after delivery
Other outcomes:
Locations:
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal
Study officials:
affiliation: CHI de Créteil
name: Marion ANDREOLETTI, MD
role: PRINCIPAL_INVESTIGATOR
References: