Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001010482
Ethics application status
Approved
Date submitted
11/08/2025
Date registered
11/09/2025
Date last updated
11/09/2025
Date data sharing statement initially provided
11/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
What Patients Want to Know about Anaesthetic Risk Information before Robotic Surgery
Scientific title
The Effect of Detailed versus Standard Anaesthetic Risk Information Sheets on Perioperative Anxiety for Patients Undergoing Robotic Gynaecological Surgery: A Multi-Centre Randomised Controlled Trial
Secondary ID [1] 315071 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perioperative anxiety 338456 0
Perioperative satisfaction 338457 0
Condition category
Condition code
Anaesthesiology 334754 334754 0 0
Anaesthetics
Mental Health 334986 334986 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will compare two types of anaesthetic risk information provided to patients undergoing robotic surgery. At the time of the pre-anaesthetic clinic appointment prior to surgery, the control group will receive a standard hospital anaesthetic risk information sheet, while the intervention group will receive both the standard information sheet and a more detailed anaesthetic risk information sheet. The detailed information sheet which will be provided to the intervention group contains extra information in regard to specific complications relevant to robotic procedures and how they may occur in relation to the special positioning required, the limited access during the operation, and sometimes the increased length of the operation. It would be expected that these information sheets could be read within approximately 30 minutes, however there is no specific time constraint given to participants. Adherence to the intervention will not be specifically monitored, an approach which aligns with the shared decision-making model outlined in the protocol and assumes participants' good-faith compliance as part of their initial informed consent to follow study procedures.
Intervention code [1] 331683 0
Treatment: Other
Comparator / control treatment
Patients in the control group will receive the standard hospital anaesthetic risk information sheet, which is the current standard of care for patients undergoing robotic surgery. This information sheet provides the basic, essential details about anaesthetic risks but does not include the additional information provided in the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 342415 0
Perioperative anxiety
Timepoint [1] 342415 0
Pre-anaesthetic information (baseline survey) Post-anaesthetic risk information (follow-up survey 1-2 weeks after baseline survey, performed immediately after receipt of standard or detailed anaesthetic risk information)
Primary outcome [2] 342773 0
Perioperative Anxiety
Timepoint [2] 342773 0
Pre-anaesthetic information (baseline survey) Post-anaesthetic risk information (follow-up survey 1-2 weeks after baseline survey, performed immediately after receipt of standard or detailed anaesthetic risk information)
Secondary outcome [1] 450724 0
Patient satisfaction with anaesthetic risk information
Timepoint [1] 450724 0
Post-anaesthetic risk information (follow-up survey 1-2 weeks after baseline survey, performed immediately after receipt of standard or detailed anaesthetic risk information)
Secondary outcome [2] 450725 0
Preparedness for decision-making
Timepoint [2] 450725 0
Pre-anaesthetic information (baseline survey) Post-anaesthetic risk information (follow-up survey 1-2 weeks after baseline survey, performed immediately after receipt of standard or detailed anaesthetic risk information)
Secondary outcome [3] 450726 0
Desire for further information
Timepoint [3] 450726 0
Post-anaesthetic risk information (follow-up survey 1-2 weeks after baseline survey, performed immediately after receipt of standard or detailed anaesthetic risk information)
Secondary outcome [4] 450727 0
Suggestions for improvement of the anaesthetic risk information sheet
Timepoint [4] 450727 0
Post-anaesthetic risk information (follow-up survey 1-2 weeks after baseline survey, performed immediately after receipt of standard or detailed anaesthetic risk information)

Eligibility
Key inclusion criteria
Patients aged 18 years or over planning to undergo robot-assisted gynaecological procedures at the participating hospitals under the single nominated surgeon.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients self-assessed as unable to understand written English, aged less than 18, lacking individual capacity to consent for their surgical procedure, and/or having received prior robot-assisted surgical procedure(s) of any type.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly assigned using sealed, opaque, numbered envelopes to ensure allocation concealment. The practice manager will carry out the allocation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done using sequential ordering of sealed, opaque, numbered envelopes that ensure an unbiased allocation to either the standard or detailed risk information group. This process will be managed by the anaesthetic practice manager, who is blinded to the study.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data will be analysed using t-tests to compare anxiety levels, preparedness for decision-making, and patient satisfaction between the two groups (standard versus detailed risk information).

Qualitative analysis will be performed on the free-text responses regarding improvement suggestions using thematic analysis based on a six-stage process described by Braun and Clarke.

Intention-to-treat analysis will be conducted, where all participants will be analysed based on their initial randomisation, regardless of whether they completed the study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/09/2025
Actual
Date of last participant enrolment
Anticipated
29/09/2026
Actual
Date of last data collection
Anticipated
13/10/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 28299 0
St Vincent's Hospital - Toowoomba
Recruitment hospital [2] 28300 0
St Andrew's Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 44511 0
4350 - Rockville
Recruitment postcode(s) [2] 44512 0
4350 - Toowoomba East

Funding & Sponsors
Funding source category [1] 319639 0
Self funded/Unfunded
Name [1] 319639 0
Dr Benjamin Cheung - St Vincent's Hospital Toowoomba
Country [1] 319639 0
Australia
Primary sponsor type
Individual
Name
Dr Benjamin Cheung - St Vincent's Hospital Toowoomba
Address
Country
Australia
Secondary sponsor category [1] 322143 0
Individual
Name [1] 322143 0
Dr Charles Halliday - Queensland Health
Address [1] 322143 0
Country [1] 322143 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318205 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 318205 0
Ethics committee country [1] 318205 0
Australia
Date submitted for ethics approval [1] 318205 0
26/05/2025
Approval date [1] 318205 0
17/06/2025
Ethics approval number [1] 318205 0
ERM ID: 119056, SAGE ID: 2025/PID00149

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

Contacts
Principal investigator
Name 143430 0
A/Prof Benjamin Cheung
Address 143430 0
St Vincent's Private Hospital, 22-36 Scott St, Toowoomba QLD 4350
Country 143430 0
Australia
Phone 143430 0
+61 07 4638 5711
Fax 143430 0
Email 143430 0
[email protected]
Contact person for public queries
Name 143431 0
Patient Liaison Officer at St Vincent’s Hospital Melbourne
Address 143431 0
St Vincent’s Hospital Melbourne, 41 Victoria Parade, Fitzroy VIC 3065
Country 143431 0
Australia
Phone 143431 0
+61 03 9231 1954
Fax 143431 0
Email 143431 0
[email protected]
Contact person for scientific queries
Name 143432 0
Benjamin Cheung
Address 143432 0
St Vincent's Private Hospital, 22-36 Scott St, Toowoomba QLD 4350
Country 143432 0
Australia
Phone 143432 0
+61 07 4690 4000
Fax 143432 0
Email 143432 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.