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What Patients Want to Know about Anaesthetic Risk Information before Robotic Surgery

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001010482
Enrollment
50
Registered
2025-09-11
Start date
2025-09-29
Completion date
2026-09-29
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to assess the impact of detailed anaesthetic risk information on patient anxiety, satisfaction, and decision-making preparedness in individuals undergoing robotic gynaecological surgery. The participants will be randomised into two groups, receiving either the standard anaesthetic risk information or both the standard and detailed information sheets. Anxiety will be measured pre- and post-intervention using validated scales (APAIS and VAS). This study is designed as a mixed-methods randomised controlled trial, with both quantitative and qualitative data collection. We hypothesise that providing patients with more detailed information about anaesthetic risks before robotic surgery will not increase their anxiety, and may improve their preparedness for decision-making and satisfaction with the consent process. The findings will contribute to improving informed consent practices and enhancing the patient experience during robotic surgery.

Interventions

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 ext

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.

Sponsors

Dr Benjamin Cheung - St Vincent's Hospital Toowoomba
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients aged 18 years or over planning to undergo robot-assisted gynaecological procedures at the participating hospitals under the single nominated surgeon.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026