Patients' Comprehension and Internalization of Operative Consent Form

Completed

• Conditions: Informed Consent

• Registration Number: NCT04627597
• Lead Sponsor: Singapore General Hospital

Brief 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.

Detailed Description

As above and in later sections.

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Study First Submitted: 2020-10-23
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-08
• Last Update Submitted: 2020-11-08
• Study First Posted: 2020-11-13
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Planned for common elective ENT operations
• English-speaking
• Unaccompanied
• Counselled with the use of a structured surgery-specific consent form

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient's perceived understanding of information given during pre-operative counselling (nominal score on questionnaire)	Through study completion, up to 6 months	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
Patient's satisfaction with pre-operative counselling (nominal score on questionnaire)	Through study completion, up to 6 months	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
Patient's actual understanding of information given during pre-operative counselling (numeric score on questionnaire)	Through study completion, up to 6 months	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