Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000593437p
Ethics application status
Submitted, not yet approved
Date submitted
13/05/2025
Date registered
10/06/2025
Date last updated
10/06/2025
Date data sharing statement initially provided
10/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Preoperative Anxiety Scores and Correlation with Post Operative Recovery in patients undergoing key hole gall bladder or hernia surgery
Scientific title
Preoperative Anxiety Scores and Correlation with Post Operative Recovery in patients undergoing laparoscopic cholecystectomy or laparoscopic hernia repair
Secondary ID [1] 314420 0
none
Universal Trial Number (UTN)
Trial acronym
PACPOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 337459 0
anaesthesia 337461 0
postoperative analgesia requirement 337462 0
Condition category
Condition code
Anaesthesiology 333835 333835 0 0
Pain management
Mental Health 333836 333836 0 0
Anxiety

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this pilot study is to utilise the validated questionnaires Amsterdam Preoperative Anxiety and information Scale (APAIS) and the Beck Anxiety Index (BAI) to identify anxious patients in the pre-admission clinic and follow up postoperatively. Patients will be stratified into high anxiety and low anxiety groups, based on baseline APAIS and BAI scores. These scales will be administered in the pre-admission clinic.
A comparison will then be made between patients with high anxiety and low anxiety about their pain medication usage, length of hospital stay and general recovery up to the next 7 post operative days..
Intervention code [1] 331053 0
Early Detection / Screening
Comparator / control treatment
Patients will be classified into high or low anxiety based on the baseline scores from the APAIS and BAI scores performed in the pre-admission clinic prior to anaesthetic and laparoscopic surgery. A comparison will be made between patients with high anxiety and low anxiety about their pain medication usage, length of hospital stay and general recovery up to the next 7 post operative days. The low anxiety group is the comparator group
Control group
Active

Outcomes
Primary outcome [1] 341444 0
Anxiety
Timepoint [1] 341444 0
Baseline, one -day after surgery
Primary outcome [2] 341670 0
The Beck Anxiety Inventory scale
Timepoint [2] 341670 0
The BAI will be tested at time zero (baseline0 in the pre-admission clinic, before the anaesthetic or procedure is performed and then done again 24 hours later.
Secondary outcome [1] 447530 0
Pain
Timepoint [1] 447530 0
The patient will be assessed with the pain scale on Day 1 post operative. If the patient is admitted to hospital, then pain assessments will be done with the scale for every day of the admission up to and including Day 7.
Secondary outcome [2] 447531 0
Post operative complications. All post operative complications will be assessed as a composite secondary outcome
Timepoint [2] 447531 0
Postoperative complications data will be gathered from patients and medical records. This data will be recorded on a daily basis starting at day 1 post operation and daily from then on up to Day 7..
Secondary outcome [3] 448050 0
Length of Hospital stay
Timepoint [3] 448050 0
This data will be gathered from the time of hospital admission after surgery (excluding day hospital stay), and recorded up to 7 days after surgery. If patients remain hospitalised after 7 days post-op, then they will be recorded as 'long stay'
Secondary outcome [4] 448291 0
Opiate use for pain relief
Timepoint [4] 448291 0
This is done by obtaining information from medical records for the period post operation and every day after until Day 7
Secondary outcome [5] 448548 0
The QoR -15, is a 15 item self rated scale used to measure overall recovery after a procedure. Scores range from zero (extremely poor recovery) to 150 points (excellent recovery)
Timepoint [5] 448548 0
Assessed once - 24 hours after surgery

Eligibility
Key inclusion criteria
- Aged over 18
- Any surgical patient that is anticipated to stay at least one night in hospital at the Alfred Health, Peninsula Health and Eastern Health hospitals.
- Able to provide informed consent
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Emergency Surgery
- Poor English comprehension – including significantly reduced cognition and/or language difficulties leading to inability to converse over the phone.
- Opiate use including recreational use in the community
- Serious mental illness including psychotic illnesses, substance use disorders and organic mental disorders
- Serious co-morbid medical illness which alone could precipitate longer hospital admissions (ASA physical status 3 or 4)
- Patient refusal to participate
- Over 75 years

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The APAIS has a maximum anxiety score of 20 (from questions 1,2,4,5) and minimum score of 5. Using a cut off score for “nil or mild anxiety” as less than 10, and moderate to severe anxiety as a score of 10 or more, enables patients to be classified into 2 groups for comparison of outcomes between ‘not anxious’ and ‘anxious’.
Demographic data will be analysed using simple comparative percentages for age, gender, education, ethnicity, past surgery (Y/N), past psychiatric history of anxiety/other conditions, preoperative medications, smoking and alcohol and illicit drug use

Study Data
- Pain scores: ordinal data which will be analysed using Wilcoxon rank sum test.
- Total opioid used total: ordinal data, analysed using Wilcoxon rank sum test.
- Use of different types of opiates i.e. fentanyl vs oxycodone, will be accounted for by using ANZCA oral morphine equivalence converter opioid calculator
- Length of stay measure will be a binary number – a) discharged as expected or b) admitted to hospital longer than expected. This data will be compared using Fisher’s exact test.

Other comparisons include correlations (rho) between anxiety scales and the QoR-15, the subjective assessment of anxiety with the BAI with objective assessment of anxiety with the APAIS. Analysis of all data will use gender, age, education and presence or absence of a psychiatry history as co-variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/07/2025
Actual
Date of last participant enrolment
Anticipated
31/03/2026
Actual
Date of last data collection
Anticipated
7/04/2026
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27940 0
The Alfred - Melbourne
Recruitment hospital [2] 27943 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 44132 0
3004 - Melbourne
Recruitment postcode(s) [2] 44135 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 318947 0
Hospital
Name [1] 318947 0
Alfred Hospital
Country [1] 318947 0
Australia
Funding source category [2] 318966 0
Hospital
Name [2] 318966 0
In kind from Frankston Hospital
Country [2] 318966 0
Australia
Primary sponsor type
Hospital
Name
Alfred health
Address
Country
Australia
Secondary sponsor category [1] 321415 0
Hospital
Name [1] 321415 0
Frankston Hospital
Address [1] 321415 0
Country [1] 321415 0
Australia
Other collaborator category [1] 283523 0
Hospital
Name [1] 283523 0
Box Hill Hospital
Address [1] 283523 0
Country [1] 283523 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317554 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 317554 0
Ethics committee country [1] 317554 0
Australia
Date submitted for ethics approval [1] 317554 0
07/05/2025
Approval date [1] 317554 0
Ethics approval number [1] 317554 0

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

Contacts
Principal investigator
Name 141422 0
Dr Christopher McGugan Wevill
Address 141422 0
C/O Frankston Hospital, 2 Hastings Rd Frankston Vic 3199
Country 141422 0
Australia
Phone 141422 0
+61 439390865
Fax 141422 0
Email 141422 0
[email protected]
Contact person for public queries
Name 141423 0
Christopher McGugan Wevill
Address 141423 0
C/O Frankston Hospital, 2 Hastings Rd Frankston Vic 3199
Country 141423 0
Australia
Phone 141423 0
+61 439390865
Fax 141423 0
Email 141423 0
[email protected]
Contact person for scientific queries
Name 141424 0
Christopher McGugan Wevill
Address 141424 0
C/O Frankston Hospital, 2 Hastings Rd Frankston Vic 3199
Country 141424 0
Australia
Phone 141424 0
+61 439390865
Fax 141424 0
Email 141424 0
[email protected]

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


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Other  [email protected] methodology protocol iattached PACPOR Methodology .docx


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.