- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05188547
Information Retention After Video (Augmented) Preoperative Anesthesiological Education
Patient education is continuously becoming more important to enable patients to participate in making decisions regarding their medical treatment. Specifically, this is also the case for preoperative education on anesthesia. Worldwide, there are many initiatives to improve preoperative patient education and subsequent level of knowledge of anesthesia, for example by using digital aids. The demand for such aids has increased significantly since the start of the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic to facilitate remote preoperative anesthesiological screening. Although many videos to educate patients on anesthesia have been developed and circulate on the internet, there has been little effort to compare this method of educating patients with the traditional one-on-one conversation between the anesthesiologist and the patient.
Objective: To compare short, mid-and long term retention of knowledge after education on anesthesia by watching a video to the traditional one-on-one explanation by the anaesthesiologist.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will be randomized into 4 arms. A control group that will only take the knowledge test after the consultation by the anesthesiologist, a baseline group that will take the knowledge test before and after the consultation to investigate the added value of a knowledge test to knowledge retention. The intervention group is divided into 2 groups. One group will see the educational video and take a knowledge test afterwards. The other group will see the educational video and visit the anesthesiologist afterwards and take the knowledge test after the consultation.
After 2 and 6 weeks patients will be asked to take the knowledge test again, to investigate knowledge retention.
The knowledge test that will be used is the Rotterdam Anesthesia Knowledge Questionnaire currently under development in the Erasmus MC Rotterdam.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jan-Wiebe Korstanje, MD, PhD
- Phone Number: 0031107040704
- Email: j.korstanje@erasmusmc.nl
Study Locations
-
-
Zuid-Holland
-
Rotterdam, Zuid-Holland, Netherlands, 3000GD
- Erasmus MC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adults visiting the preoperative anesthesia clinic
- elective surgery
- able to read, write and understand the Dutch language
Exclusion Criteria:
- cardiothoracic surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No video education, only consultation by the anesthesiologist.
No knowledge test before the consultation.
|
|
No Intervention: Baseline
No video education, only consultation by the anesthesiologist.
Also a knowledge test before the consultation.
|
|
Experimental: Video
Video education and a knowledge test directly afterwards.
Consultation by the anesthesiologist after the knowledge test.
|
Participants will be shown a video educating them on anesthesia and perioperative instructions.
|
Experimental: Video Augmented
Video education and consultation by the anesthesiologist directly afterwards.
The knowledge test is taken after the consultation.
|
Participants will be shown a video educating them on anesthesia and perioperative instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Information retention short-term
Time Frame: Immediately after the information is provided
|
Score on the Rotterdam Anesthesia Knowledge Questionnaire (RAKQ).
Results will be expressed as the percentage correct answers of the total number of questions.
A higher score means a better knowledge level.
|
Immediately after the information is provided
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Information retention mid-term
Time Frame: Two weeks after the information is provided compared to directly after the information is provided.
|
Difference in score on the Rotterdam Anesthesia Knowledge Questionnaire (RAKQ).
Results will be expressed as the percentage correct answers of the total number of questions.
A higher score means a better knowledge level.
|
Two weeks after the information is provided compared to directly after the information is provided.
|
Anxiety
Time Frame: Immediately after the information is provided
|
Difference in score on the APAIS (Amsterdam Preoperative Anxiety and Information Scale).
Scores can be between 6 and 30 points, with a higher score meaning a more anxious patient, more in need for information about the surgery and anesthesia.
|
Immediately after the information is provided
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jan-Wiebe Korstanje, MD MSc PhD, Erasmus Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MEC-2021-0769
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Whom: Investigators whose proposed use of the data has been approved by the principal investigator or its research team.
What types of analyses: To achieve aims in the approved proposal What mechanism: Proposals can be filed at our website: https://www.digica-erasmusmc.nl. To gain access requestors will need to sign a data access agreement, data transfer agreement and any other agreement deemed necessary by our institution for safe data sharing.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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