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OpenTrials
Completed

NCT Number: NCT04627597

Patients' Comprehension and Internalization of Operative Consent Form

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.

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Key information

Conditions

Informed Consent

Sex eligibility

All sexes

Study type

Observational

About this study

As above and in later sections.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Patient's perceived understanding of information given during pre-operative counselling (nominal score on questionnaire)

    Time frame: 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

  2. Patient's actual understanding of information given during pre-operative counselling (numeric score on questionnaire)

    Time frame: 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

  3. Patient's satisfaction with pre-operative counselling (nominal score on questionnaire)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Official study title

Informed Pre-operative Consent: Are We There Yet?

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 13, 2020
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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