Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001310853
Ethics application status
Approved
Date submitted
18/08/2021
Date registered
27/09/2021
Date last updated
27/09/2021
Date data sharing statement initially provided
27/09/2021
Date results information initially provided
27/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of endoscopy sedation information sheets on the level of concern regarding possible awareness in patients undergoing endoscopy sedation
Scientific title
The impact of endoscopy sedation information sheets on the level of concern regarding possible awareness in patients undergoing endoscopy sedation
Secondary ID [1] 305087 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endoscopy related investigations 323305 0
Condition category
Condition code
Anaesthesiology 320869 320869 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will be sent in the mail the Australian Society of Anaesthetists “Anaesthesia for Endoscopy” information sheet at least one week prior to their scheduled endoscopy. This is a one page document of estimated reading time 5 minutes.
On the day of the procedure the intervention group also received the Queensland Health "Anaesthetic Consent Information". Adherence to the intervention was checked on the day of anaesthesia via a verbal question of whether the patient had read the information sheet.
Intervention code [1] 321480 0
Prevention
Comparator / control treatment
The control group will receive only the Queensland Health "Anaesthetic Consent Information" on the day of the procedure, at least 1 hour prior to scheduled endoscopy. This is a 4 page document of estimated reading time 15 minutes. Completion of the consent form must legally be undertaken before the procedure can be commenced and will be checked by clinical staff.
Control group
Active

Outcomes
Primary outcome [1] 328667 0
Concern about being aware during the procedure as measured by a survey designed specifically for this study.
Timepoint [1] 328667 0
Pre-procedure survey
Secondary outcome [1] 399874 0
Self-reported level of sedation knowledge via the study specific questionnaire.
Timepoint [1] 399874 0
Pre-procedure
Secondary outcome [2] 399875 0
Recall being aware during procedure as measured by a post-procedure questionnaire designed specifically for this study.
Timepoint [2] 399875 0
Only one post-procedure survey was undertaken within 30 minutes of the procedure.
Secondary outcome [3] 399876 0
Incidence of adverse events -
- Nausea and vomiting - Self-report on 10-point scale
- Pain - Self-report on 10-point scale
- Excessive sleepiness - Self-report on 10-point scale
- Respiratory complications - measured via clinical observations by nursing staff
Timepoint [3] 399876 0
Nausea and vomiting, pain, and excessive sleepiness was measured post-procedure within 30 minutes of procedure.
The respiratory complications component was monitored post-procedure until discharge from hospital.
Secondary outcome [4] 399877 0
Satisfaction with pre-endoscopy care via the survey designed specifically for this study
Timepoint [4] 399877 0
Post-procedure survey within 30 minutes of procedure.
Secondary outcome [5] 399878 0
Satisfaction with overall anaesthetic care via the survey designed specifically for this study
Timepoint [5] 399878 0
Post-procedure survey within 30 minutes of procedure.

Eligibility
Key inclusion criteria
- adequate English comprehension with no language barrier, cognitive deficit or intellectual barrier
- adequate English reading level equivalent to a grade 8 student or above
- no significant cardiovascular or respiratory impairment (ASA IV and V)
- outpatient endoscopies.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- emergency and inpatient endoscopies.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome, level of concern regarding possible awareness during sedation, was analysed using the Chi-square non-parametric test.
Outcomes which produced nominal or ordinal data were analysed as per the primary outcome measure. Secondary outcome measures which produced interval data were analysed using an Analysis of Co-Variance (ANCOVA) for normally distributed data, to enable adjustment for co-variates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2017
Date of last participant enrolment
Anticipated
Actual
31/12/2017
Date of last data collection
Anticipated
Actual
31/12/2017
Sample size
Target
198
Accrual to date
Final
187
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20300 0
Mackay Base Hospital - Mackay
Recruitment postcode(s) [1] 35041 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 309484 0
Charities/Societies/Foundations
Name [1] 309484 0
Private Practice Trust Fund (PPTF) Mackay Base Hospital
Country [1] 309484 0
Australia
Primary sponsor type
Hospital
Name
Mackay Hospital and Health Service
Address
475 Bridge Rd, Mackay QLD 4740
Country
Australia
Secondary sponsor category [1] 310456 0
None
Name [1] 310456 0
Address [1] 310456 0
Country [1] 310456 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309271 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 309271 0
100 Angus Smith Dr, Douglas QLD 4814
Ethics committee country [1] 309271 0
Australia
Date submitted for ethics approval [1] 309271 0
22/05/2016
Approval date [1] 309271 0
27/06/2016
Ethics approval number [1] 309271 0
HREC/16/QTHS/98

Summary
Brief summary
This study investigates the role of endoscopy sedation information sheets in reducing the level of concern regarding possible awareness during the procedure. We hypothesised that concern of awareness would be reduced with the introduction of the information sheet in the intervention group compared with control group receiving only the standard procedure consent form.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113574 0
Dr Zi Ping Tong
Address 113574 0
Mackay Hospital and Health Service
475 Bridge Rd, Mackay QLD 4740
Country 113574 0
Australia
Phone 113574 0
+61 7 4885 6000
Fax 113574 0
Email 113574 0
[email protected]
Contact person for public queries
Name 113575 0
Dr Zi Ping Tong
Address 113575 0
Mackay Hospital and Health Service
475 Bridge Rd, Mackay QLD 4740
Country 113575 0
Australia
Phone 113575 0
+61 7 4885 6000
Fax 113575 0
Email 113575 0
[email protected]
Contact person for scientific queries
Name 113576 0
Dr Zi Ping Tong
Address 113576 0
Mackay Hospital and Health Service
475 Bridge Rd, Mackay QLD 4740
Country 113576 0
Australia
Phone 113576 0
+61 7 4885 6000
Fax 113576 0
Email 113576 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All IPD that underlie results in a publication
When will data be available (start and end dates)?
From January 1, 2022 with no end date.
Available to whom?
Public accessibility to anyone who wishes to access the data.
Available for what types of analyses?
The data will be available for any purpose.
How or where can data be obtained?
By emailing the principle investigator [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12937Ethical approval    382629-(Uploaded-18-08-2021-16-56-17)-Study-related document.pdf
12938Informed consent form    382629-(Uploaded-18-08-2021-16-57-11)-Study-related document.doc



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.