Will a preoperative video on anaesthesia better stick than a consultation with an anesthesiologist?
| ISRCTN | ISRCTN13174388 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13174388 |
| Secondary identifying numbers | rakq_pilot |
- Submission date
- 16/08/2022
- Registration date
- 17/08/2022
- Last edited
- 17/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
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 COVID-19 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. The aim of this study is to establish if it is feasible to use video education in a larger trial, how large of an effect video eduction might have on participants remembering specific details of the video over time, and if participants are willing to keep participating over time.
Who can participate?
Adults visiting the preoperative anesthesia clinic who are scheduled for elective surgery
What does the study involve?
The study involves participants watching a video about general anaesthesia and filling out a questionnaire specifically directly after watching the video and after 14 and 42 days.
What are the possible benefits and risks of participating?
The positive benefits of participating are a possible better understanding of what anesthesia is and what its associated risks are. There are no risks involved in this study.
Where is the study run from?
Erasmus MC (Netherlands)
When is the study starting and how long is it expected to run for?
June 2020 to October 2021
Who is funding the study?
Health-Holland (Netherlands)
Who is the main contact?
Dr J.-W.H. Korstanje, j.korstanje@erasmusmc.nl
Contact information
Principal Investigator
Dr. Molenwaterplein 40
Rotterdam
3015 GD
Netherlands
 ORCID ID |
0000-0002-6269-9860 |
|---|---|
| Phone | +31 (0)107040704 |
| j.korstanje@erasmusmc.nl |
Study information
| Study design | Single-center interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Information retention after video (augmented) preoperative anesthesiological education: a pilot study |
| Study objectives | 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. However, effects size and loss-to-follow up remain unknown and need to be addressed before proceeding to a sufficiently powered large-scale randomized controlled trial (RCT). |
| Ethics approval(s) | Approved 16/11/2020, Erasmus MC Medical Ethical Committee (Erasmus Medical Center Rotterdam, Dr.Molewaterplein 40, 3015 GD Rotterdam, Netherlands; +31 (0)10 7033625, metc@erasmusmc.nl), ref: MEC-2020-0839 |
| Health condition(s) or problem(s) studied | Information retention after preoperative assessment by anaesthesiologist or video education in patients scheduled for surgery |
| Intervention | Participants will be allocated by simple randomization (1:1:1:1) embedded in the trial software (E+POS by NovaCair) to one of four arms: 1. A control group that will only fill out the Rotterdam Anesthesia Knowledge Questionnaire (RAKQ) after the consultation by the anesthesiologist. 2. A baseline group that will fill out the RAKQ before and after the consultation to investigate the added value of a knowledge test to knowledge retention. The intervention group is divided into two groups: 1. One group will see the educational video and fill out the RAKQ afterwards. 2. The other group will see the educational video and visit the anesthesiologist afterwards and take the knowledge test after the consultation. All participants were presented with questionnaires on level of education, satisfaction, subjective knowledge and preoperative anxiety (APAIS) after filling out the RAKQ for the first time. Intermediate and long-term knowledge retention was measured by repeating the RAKQ in all groups except the baseline group, after 14 and 42 days. |
| Intervention type | Behavioural |
| Primary outcome measure | The effect size (Cohen's d) of video (augmented) preoperative anesthesiological education measured using the RAKQ at baseline, 14 and 42 days |
| Secondary outcome measures | 1. Recruitment rate measured as the number of participants recruited per month of the study 2. Loss to follow-up measured as the number of participants lost at baseline, 14 and 42 days |
| Overall study start date | 01/06/2020 |
| Completion date | 28/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 146 |
| Key inclusion criteria | 1. Adults visiting the preoperative anesthesia clinic 2. Scheduled for elective surgery 3. Able to read, write and understand the Dutch language |
| Key exclusion criteria | 1. Cardiothoracic surgery 2. Caesarian sections |
| Date of first enrolment | 01/04/2021 |
| Date of final enrolment | 16/09/2021 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Rotterdam
3015 GD
Netherlands
Sponsor information
Hospital/treatment centre
Dr Molenwaterplein 40
Rotterdam
3015 GD
Netherlands
| Phone | +31 (0)107040704 |
|---|---|
| info@erasmusmc.nl | |
| Website | http://www.erasmusmc.nl/ |
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Top Sector Life Sciences & Health, Dutch Life Sciences & Health, Dutch LSH, Top Sector LSH, LSH
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The generated datasheet will most likely be made available through KNAW-DANS (Royal Dutch Academy of Sciences - Data Archiving and Network Services) accessible through https://dans.knaw.nl/ after verification both with KNAW-DANS and the principal investigator. |
Editorial Notes
17/08/2022: Trial's existence confirmed by Erasmus MC Medical Ethical Committee.
