Impact of a Video Explaining Epidural Analgesia in Obstetrics

Difficulty Processing Information Clinical Trial

— VIDEOCLIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02899806
• Other study ID #: VIDEOCLIP
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: October 2017

Study information

• Verified date: July 2017
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: October 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Difficulty Processing Information

Intervention

Other:
• Written Information
A written information on peridural anesthesia is delivered
• Video Information
A link to a video explaining peridural anesthesia is delivered to the pregnant woman. The patient can watch the video several times.

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction evaluated by numerical scale from 0 to 10		during the 48 hour after delivery
Secondary	Comprehension was evaluated by by multiple choice questions with a final score of 10		during the 48 hour after delivery
Secondary	Anxiety was evaluated by numerical scale from 0 to 10		during the 48 hour after delivery