Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT06115720
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2023-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Consent in Anaesthesia
Sponsor:
Imperial College Healthcare NHS Trust
Organization:
Study Overview
Official Title:
CIA: Consent in Anaesthesia, Prospective Randomised-controlled Trial
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIA
Brief Summary:
DESIGN: Prospective randomised-controlled trial AIM: To determine whether presenting both techniques of general anaesthesia and regional anaesthesia in an unbiased manner, with video media, aids the anaesthetic consent process, compared to standard verbal consent alone.
OUTCOME MEASURES
Primary outcome:
\- Participants' satisfaction regarding the anaesthetic consent process
Secondary outcomes:
* Knowledge, attitudes and practices towards anaesthesia
* Participants' choice of anaesthetic technique POPULATION: General adult population (\>18yrs), males and females DURATION: 2 years
OUTCOME MEASURES
Primary outcome:
\- Participants' satisfaction regarding the anaesthetic consent process
Secondary outcomes:
* Knowledge, attitudes and practices towards anaesthesia
* Participants' choice of anaesthetic technique POPULATION: General adult population (\>18yrs), males and females DURATION: 2 years
Detailed Description:
The main aim of this study is to determine if presenting both anaesthetic techniques of general anaesthesia (GA) and regional anaesthesia (RA) to a participant in an unbiased manner, with video media, affects the participants' satisfaction, knowledge of, and attitudes towards anaesthesia. The investigators hypothesise that using video media will improve participants' satisfaction with the anaesthetic consent process, thereby resulting in better quality informed consent.
Participant's knowledge retention, attitudes and practices towards GA and RA, measured by an knowledge, attitudes and practices (KAP) questionnaire based on the consent process. Participant's stated preference for anaesthetic technique (i.e. General or Regional).
Several studies have shown that video-based patient education have led to better patient comprehension and satisfaction as well as reduced patient anxiety during the consent process compared to verbal consent.
Examples The use of portable video media vs standard verbal communication in the urological consent process: a multicentre, randomised controlled, crossover trial showed that 80.7% of patients preferred portable video media (PVM) and 19.3% preferred standard video consent (SVC). PVM improves patient's understanding compared with SVC and is a more effective means of content delivery to patients in terms of overall preference and knowledge gained during the consent process.
Effect of preoperative multimedia information on perioperative anxiety in patients undergoing procedures under regional anaesthesia, showed that preoperative multimedia information reduces the anxiety of patients undergoing surgery under regional anaesthesia. This type of information is easily delivered and can benefit many patients.
Oxford Video Informed Consent Tool (OxVIC): a pilot study of informed video consent in spinal surgery and preoperative patient satisfaction concluded: "Introduction of a video consent tool was found to be a positive adjunct to traditional consenting methods. Patient-clinician consent dialogue can now be documented. A randomised controlled study to further evaluate the effects of video consent on patients' retention of information, preoperative and postoperative anxiety, patient reported outcome measures as well as length of stay may be beneficial."
During the Covid pandemic, with the need for social distancing, this is particularly useful and allows for involvement of family support for decision making by allowing sufficient time for informed consent to be made.
The aim of this study is to determine if the use of video assisted consent during the anaesthetic consent process, for both GA and RA, affects the participants' satisfaction, knowledge of, and attitudes towards, anaesthesia.
The investigators hypothesise that using video media will improve participant knowledge, understanding and satisfaction of the anaesthetic consent process, thereby resulting in better quality informed consent.
Participant's knowledge retention, attitudes and practices towards GA and RA, measured by an knowledge, attitudes and practices (KAP) questionnaire based on the consent process. Participant's stated preference for anaesthetic technique (i.e. General or Regional).
Several studies have shown that video-based patient education have led to better patient comprehension and satisfaction as well as reduced patient anxiety during the consent process compared to verbal consent.
Examples The use of portable video media vs standard verbal communication in the urological consent process: a multicentre, randomised controlled, crossover trial showed that 80.7% of patients preferred portable video media (PVM) and 19.3% preferred standard video consent (SVC). PVM improves patient's understanding compared with SVC and is a more effective means of content delivery to patients in terms of overall preference and knowledge gained during the consent process.
Effect of preoperative multimedia information on perioperative anxiety in patients undergoing procedures under regional anaesthesia, showed that preoperative multimedia information reduces the anxiety of patients undergoing surgery under regional anaesthesia. This type of information is easily delivered and can benefit many patients.
Oxford Video Informed Consent Tool (OxVIC): a pilot study of informed video consent in spinal surgery and preoperative patient satisfaction concluded: "Introduction of a video consent tool was found to be a positive adjunct to traditional consenting methods. Patient-clinician consent dialogue can now be documented. A randomised controlled study to further evaluate the effects of video consent on patients' retention of information, preoperative and postoperative anxiety, patient reported outcome measures as well as length of stay may be beneficial."
During the Covid pandemic, with the need for social distancing, this is particularly useful and allows for involvement of family support for decision making by allowing sufficient time for informed consent to be made.
The aim of this study is to determine if the use of video assisted consent during the anaesthetic consent process, for both GA and RA, affects the participants' satisfaction, knowledge of, and attitudes towards, anaesthesia.
The investigators hypothesise that using video media will improve participant knowledge, understanding and satisfaction of the anaesthetic consent process, thereby resulting in better quality informed consent.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 23SM8319 | OTHER | Imperial College Healthcare NHS Trust | View |