Informed ConsentNCT04627597
Patients' Comprehension and Internalization of Operative Consent Form
An observational study of Informed Consent, run by Singapore General Hospital.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Informed Consent
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients planned for common elective ENT operations in a tertiary hospital between July and December 2016
Who may be able to join
- Planned for common elective ENT operations
- English-speaking
- Unaccompanied
- Counselled with the use of a structured surgery-specific consent form
Who cannot join
None listed.
About this study
Official title: Informed Pre-operative Consent: Are We There Yet?
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.
Read the detailed description
As above and in later sections.
- Conditions
- Informed Consent
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, up to 6 months
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
Measured: Through study completion, up to 6 months
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
Measured: Through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Jul 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Informed ConsentStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tze Choong Charn, MRCS, Principal investigator, Singhealth Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627597
- Sponsor's protocol ID
- 2016/2638
- Status last verified
- Nov 2020
- First submitted
- 23 Oct 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informed Pre-operative Consent: Are We There Yet?
- ClinicalTrials.gov ID
- NCT04627597
- Acronym / sponsor ID
- 2016/2638
- Conditions
- Informed Consent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients planned for common elective ENT operations in a tertiary hospital between July and December 2016
Key inclusion criteria (4 listed)
- Planned for common elective ENT operations
- English-speaking
- Unaccompanied
- Counselled with the use of a structured surgery-specific consent form
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tze Choong Charn, MRCS principal investigator
Singhealth Foundation
Questions about this trial
What is this clinical trial studying?
An observational study of Informed Consent, run by Singapore General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.