NCT04627597

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

October 23, 2020

Last Update Submit

November 8, 2020

Conditions

Informed Consent

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients planned for common elective ENT operations in a tertiary hospital between July and December 2016

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Tze Choong Charn, MRCS

    Singhealth Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2020

First Posted

November 13, 2020

Study Start

July 1, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share