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NCT04627597 Clinical Trial

Patients' Comprehension and Internalization of Operative Consent Form

Informed Consent Clinical Trial

Official title:
Informed Pre-operative Consent: Are We There Yet?

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date November 2020
Source Singapore General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

As above and in later sections.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Singapore General Hospital

Outcome
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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