Consent Forms of ERCP
Conditions
Keywords
informed consent, ERCP, video
Brief summary
To prove that video about endoscopic retrograde cholangiopancreatography (ERCP) combined with written informed consent provides participants more information about the procedure, which can make participants understand the procedure well. Investigators advocate the development of institutional and national guidelines to ensure optimal practices of acquiring informed consent.
Interventions
PROCEDUREwritten informed consent
PROCEDUREvideo+written informed consent
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* All inpatients who will receive ERCP
Exclusion criteria
* under 18 years or more than 70 years * pregnancy or breast-feeding women * circulatory and respiratory disorders * mental illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time for informed consent practices before ERCP | 2 days |
| time for extra explanation about ERCP | 2 days |
Secondary
| Measure | Time frame |
|---|---|
| satisfaction degree about the informed consent practices | 2 days |
Other
| Measure | Time frame |
|---|---|
| anxiety level after the informed consent practices | 2 days |
Countries
China
Contacts
Primary ContactZhaoshen Li, MD
Backup ContactYu Bai, MD
Outcome results
None listed