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Trial registered on ANZCTR


Registration number
ACTRN12617001398392p
Ethics application status
Not yet submitted
Date submitted
28/09/2017
Date registered
4/10/2017
Date last updated
4/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the provision of patient information brochures for adult emergency appendicectomy surgery patients, reduce their anxiety ?
Scientific title
Does the provision of patient information brochures for adult emergency appendicectomy surgery patients, reduce their anxiety: A randomised sequential mixed method study
Secondary ID [1] 293004 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety in preoperative emergency surgery patients 304918 0
Condition category
Condition code
Mental Health 304244 304244 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomly assigned preoperative information before appendicectomy surgery. The study will use privately produced PDF emergency surgery patient information leaflets normally costing in the region of $1 per patient to use under licence. The licence fee has been waived for the purpose of this study by the company EIDO Health Australia.
The emergency surgery patient information leaflets describe accepted clinical practice and carry the Royal Australasian College of Surgeons (RACS) and Royal Australian and New Zealand College of Ophthalmologists (RANZCO) Coat of Arms. They are also endorsed by Colleges and Associations around the world including the Association of Surgeons of Great Britain and Ireland, the Royal College of Surgeons of England, the Royal College of Surgeons of Edinburgh, the Royal College of Ophthalmologists, the British Association of Paediatric Surgeons and the British Association of Day Surgery. The emergency surgery patient information leaflets are validated by clinicians, proof readers and external organisations such as the independent Plain English Campaign. The emergency surgery patient information leaflets are also endorsed by the Australian Patients Association.

The information will be given (in the study group) after the patient has had surgery booked, no later than 4 hours before surgery is scheduled.
The measure of anxiety will occur when surgery is booked and again after the patient has read the information (study) or 2 hours later.
Intervention code [1] 299244 0
Prevention
Comparator / control treatment
The control group will have 'business as usual'- no specific written preoperative information will be provided before emergency surgery
Control group
Active

Outcomes
Primary outcome [1] 303530 0
Measure of anxiety on a State Anxiety Form in preoperative surgical patients
Timepoint [1] 303530 0
2 hours after receiving preoperative information
Secondary outcome [1] 339210 0
Subjective measures of levels of satisfaction with preoperative information determined from 4 questions:
1. How satisfied were you with the information you were given before surgery on a scale of 0-10 (with 0 being “Not satisfied” and 10 being “Very Satisfied”) and why did you give that score?
2. What did you find most useful about the information you were given before surgery?
3. What would you change or improve about information given before emergency surgery?
4. Would you recommend printed emergency surgery patient information be given to other patients having emergency surgery?
Timepoint [1] 339210 0
1 week after surgery via a telephone interview

Eligibility
Key inclusion criteria
1. Patient having emergency appendicectomy surgery
2. Aged 18 years or older
3. Emergency surgery booked with 8hr surgical clinical priority or greater
4. Patients with English as a first language
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient having elective surgery
2. Patient having emergency surgery other than appendicectomy
3. Age <18 years
4. Emergency surgery booked with <=15 min, <=1 hour or <=4 hour surgical clinical priority
5. Moribund or obtunded patient
6. Patient with ASA (American Society of Anaesthesiologists physical status classification) Score 5: A moribund patient who is not expected to survive without the operation
7. Patient with ASA Score 6: a declared brain-dead patient whose organs are being removed for donor purposes
8. Patients who are unable to read printed information
9. Patients from CALD (Cultural And Linguistically Diverse) background for whom English is not their first language
10. Patients who are unable to read the printed emergency surgery patient information leaflets or STAI FORM Y-1 (State Trait Anxiety Form version Y-1)
11. Patients who die before or during surgery
12. Patients who die after surgery but before they can complete the STAI FORM Y-1

Study design
Purpose of the study
Educational / counselling / training
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)
Simple randomisation using a randomisation table created by computer software (i.e. 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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2018
Actual
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
31/12/2018
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9121 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 17627 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 297630 0
Hospital
Name [1] 297630 0
Wollongong Hospital
Country [1] 297630 0
Australia
Primary sponsor type
Government body
Name
Illawarra Shoalhaven Local Health District
Address
Crown Street Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 296648 0
None
Name [1] 296648 0
Address [1] 296648 0
Country [1] 296648 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298718 0
Wollongong and Illawarra Shoalhaven LHD Health and Medical HREC
Ethics committee address [1] 298718 0
Ethics committee country [1] 298718 0
Australia
Date submitted for ethics approval [1] 298718 0
01/11/2017
Approval date [1] 298718 0
Ethics approval number [1] 298718 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78006 0
Mr James Brinton
Address 78006 0
Illawarra Shoalhaven Local Health District- Wollongong Hospital
Offices of the Division of Surgery Block B Level 2
Loftus Street WOLLONGONG NSW 2500
Locked Bag 8808 SOUTH COAST MAIL CENTRE NSW 2521
Country 78006 0
Australia
Phone 78006 0
+61 466563876
Fax 78006 0
Email 78006 0
james.brinton@health.nsw.gov.au
Contact person for public queries
Name 78007 0
James Brinton
Address 78007 0
Illawarra Shoalhaven Local Health District- Wollongong Hospital
Offices of the Division of Surgery Block B Level 2
Loftus Street WOLLONGONG NSW 2500
Locked Bag 8808 SOUTH COAST MAIL CENTRE NSW 2521
Country 78007 0
Australia
Phone 78007 0
+61 466563876
Fax 78007 0
Email 78007 0
james.brinton@health.nsw.gov.au
Contact person for scientific queries
Name 78008 0
James Brinton
Address 78008 0
Illawarra Shoalhaven Local Health District- Wollongong Hospital
Offices of the Division of Surgery Block B Level 2
Loftus Street WOLLONGONG NSW 2500
Locked Bag 8808 SOUTH COAST MAIL CENTRE NSW 2521
Country 78008 0
Australia
Phone 78008 0
+61 466563876
Fax 78008 0
Email 78008 0
james.brinton@health.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.