Informed Consent Clinical Trial
Official title:
Informed Pre-operative Consent: Are We There Yet?
NCT number | NCT04627597 |
Other study ID # | 2016/2638 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2016 |
Est. completion date | December 31, 2016 |
Verified date | November 2020 |
Source | Singapore General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a prospective pilot study conducted within otolaryngology (ENT) clinics in a tertiary hospital between July and December 2016. 22 patients planned for common elective ENT operations were given a self-administered one-page survey on the same day after preoperative counselling. The investigators aim to identify if there are any associations between perceived and actual understanding of information given during pre-operative counselling and patient satisfaction with the process.
Status | Completed |
Enrollment | 22 |
Est. completion date | December 31, 2016 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Planned for common elective ENT operations - English-speaking - Unaccompanied - Counselled with the use of a structured surgery-specific consent form |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient's perceived understanding of information given during pre-operative counselling (nominal score on questionnaire) | The score of how certain patients feel about information given during pre-operative counselling, as indicated on a self-administered questionnaire on the same day after pre-operative counselling | Through study completion, up to 6 months | |
Primary | Patient's actual understanding of information given during pre-operative counselling (numeric score on questionnaire) | The score of correct answers patients give to factual questions about their surgery, as indicated on a self-administered questionnaire on the same day after pre-operative counselling | Through study completion, up to 6 months | |
Primary | Patient's satisfaction with pre-operative counselling (nominal score on questionnaire) | The score of how satisfied patients are with pre-operative counselling, as indicated on a self-administered questionnaire on the same day after pre-operative counselling | Through study completion, up to 6 months |
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