Difficulty Processing InformationVIDEOCLIPNCT02899806
Impact of a Video Explaining Epidural Analgesia in Obstetrics
A study testing Written Information and Video Information in people with Difficulty Processing Information, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Difficulty Processing Information
- What is being tested?
- Written Information and Video Information
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 301 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant woman
- Affiliated to social security system
- Understanding French language
- Internet access
- >18 years old and not subject to a measure of legal protection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Video Explaining Epidural Analgesia in Obstetrics in Terms of Satisfaction, Understanding and Anxiety: A Prospective Randomised Trial
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.
Read the 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.
- Conditions
- Difficulty Processing Information
- Being tested
- Written Information, Video Information
- Keywords
- Video Information, Satisfaction, Anxiety, Epidural Analgesia, Comprehension, delivery
- Medical subject headings
- Personal Satisfaction, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written InformationOther
A written information on peridural anesthesia is delivered
Video InformationOther
A link to a video explaining peridural anesthesia is delivered to the pregnant woman. The patient can watch the video several times.
| Study group | Role | What they receive |
|---|---|---|
| Paper | Placebo comparator | Information about epidural analgesia by oral and paper sheep given by anesthesist in programed consultation Receives: Other: Written Information |
| Video | Experimental | Video information in addition to oral and written information gave by anesthesist in programed consultation Receives: Other: Written Information; Other: Video Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction evaluated by numerical scale from 0 to 10
Measured: during the 48 hour after delivery
Secondary outcomes (2)
Comprehension was evaluated by by multiple choice questions with a final score of 10
Measured: during the 48 hour after delivery
Anxiety was evaluated by numerical scale from 0 to 10
Measured: during the 48 hour after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startSep 2015
- Primary completionOct 2015
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficulty Processing InformationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marion ANDREOLETTI, Centre Hospitalier Intercommunal Creteil
- Investigators
- Marion ANDREOLETTI, MD, Principal investigator, CHI de Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899806
- Sponsor's protocol ID
- VIDEOCLIP
- Acronym
- VIDEOCLIP
- Status last verified
- Jul 2017
- First submitted
- 30 Aug 2016
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Video Explaining Epidural Analgesia in Obstetrics in Terms of Satisfaction, Understanding and Anxiety: A Prospective Randomised Trial
- ClinicalTrials.gov ID
- NCT02899806
- Acronym / sponsor ID
- VIDEOCLIP / VIDEOCLIP
- Conditions
- Difficulty Processing Information
- Keywords
- Video Information, Satisfaction, Anxiety, Epidural Analgesia, Comprehension, delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paper | Placebo comparator | Other: Written InformationInformation about epidural analgesia by oral and paper sheep given by anesthesist in programed consultation |
| Video | Experimental | Other: Written Information, Other: Video InformationVideo information in addition to oral and written information gave by anesthesist in programed consultation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant woman
- Affiliated to social security system
- Understanding French language
- Internet access
- >18 years old and not subject to a measure of legal protection
Key exclusion criteria (6 listed)
- Contre indications to epidural
- Refusal to participate in the study
- Not affiliated with the Social Security system
- No understanding French
- No access to Internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written InformationA written information on peridural anesthesia is delivered | Other | Paper, Video |
| Video InformationA link to a video explaining peridural anesthesia is delivered to the pregnant woman. The patient can watch the video several times. | Other | Video |
Primary outcome
Satisfaction evaluated by numerical scale from 0 to 10
Time frame: during the 48 hour after delivery
2 secondary outcomes
Comprehension was evaluated by by multiple choice questions with a final score of 10
Time frame: during the 48 hour after delivery
Anxiety was evaluated by numerical scale from 0 to 10
Time frame: during the 48 hour after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion ANDREOLETTI, MD principal investigator
CHI de Créteil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Information and Video Information in people with Difficulty Processing Information, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction evaluated by numerical scale from 0 to 10 (time frame: during the 48 hour after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.