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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
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Scientific title
Preoperative Anxiety Scores and Correlation with Post Operative Recovery in patients undergoing laparoscopic cholecystectomy or laparoscopic hernia repair
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Secondary ID [1]
314420
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none
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Universal Trial Number (UTN)
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Trial acronym
PACPOR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
anxiety
337459
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anaesthesia
337461
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postoperative analgesia requirement
337462
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Condition category
Condition code
Anaesthesiology
333835
333835
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0
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Pain management
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Mental Health
333836
333836
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0
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Anxiety
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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..
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Intervention code [1]
331053
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Early Detection / Screening
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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
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Control group
Active
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Outcomes
Primary outcome [1]
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Anxiety
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Assessment method [1]
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The Amsterdam Preoperative Anxiety and information Scale (APAIS) is the primary measure of anxiety. 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 <10, and moderate to severe anxiety as 10 or more points. Patients will be classified into 2 groups for comparison of outcomes between ‘not anxious’ and ‘anxious’.
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Timepoint [1]
341444
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Baseline, one -day after surgery
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Primary outcome [2]
341670
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The Beck Anxiety Inventory scale
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Assessment method [2]
341670
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The BAI is a self-administered 21 item scale, rating the severity of anxiety symptoms from 0 to 3. The total possible score is 63 where 0-7 is minimum anxiety, 8-15 is mild, 16-25 is moderate and 26-63 is severe anxiety.
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Timepoint [2]
341670
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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.
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Secondary outcome [1]
447530
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Pain
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Assessment method [1]
447530
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The patient will be asked on the first day post-surgery to record numeric rating scale for pain (0 to 10, with 10 representing severe pain). This pain score will be used to assess pain.
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Timepoint [1]
447530
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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.
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Secondary outcome [2]
447531
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Post operative complications. All post operative complications will be assessed as a composite secondary outcome
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Assessment method [2]
447531
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All post operative complications such as infection, other wound complications, any other morbidity such as DVT, general infections, cardiovascular or renal complications will be recorded in detail, but combined into a binary 'yes/no' recording for the purposes of this study.
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Timepoint [2]
447531
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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..
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Secondary outcome [3]
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Length of Hospital stay
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Assessment method [3]
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Inpatient hospitalisation stay after surgery will be recorded. This excludes time spent in day hospital, immediately after surgery. This data will be obtained from hospital records
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Timepoint [3]
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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'
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Secondary outcome [4]
448291
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Opiate use for pain relief
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Assessment method [4]
448291
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Pain relief will also be assessed by measuring the opiate drug usage for pain relief.All opiate medication administered to the patient will be recorded for type, dose and route of administration. Use of different types of opiates i.e. fentanyl vs oxycodone, will be accounted for by using ANZCA oral morphine equivalence converter opioid calculator. The drug information will be obtained from medical records and prescriptions.The drug dosages will be converted into OMEDD’s for the purposes of statistical analysis.
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Timepoint [4]
448291
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This is done by obtaining information from medical records for the period post operation and every day after until Day 7
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Secondary outcome [5]
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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)
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Assessment method [5]
448548
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24 hours after surgery, patients will self-rate their recovery using the QoR. The scale score total will be recorded by the researchers
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Timepoint [5]
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Assessed once - 24 hours after surgery
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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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
14/07/2025
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Actual
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Date of last participant enrolment
Anticipated
31/03/2026
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Actual
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Date of last data collection
Anticipated
7/04/2026
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Actual
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Sample size
Target
110
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
27940
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The Alfred - Melbourne
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Recruitment hospital [2]
27943
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Frankston Hospital - Frankston
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Recruitment postcode(s) [1]
44132
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3004 - Melbourne
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Recruitment postcode(s) [2]
44135
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3199 - Frankston
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Funding & Sponsors
Funding source category [1]
318947
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Hospital
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Name [1]
318947
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Alfred Hospital
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Address [1]
318947
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Country [1]
318947
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Australia
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Funding source category [2]
318966
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Hospital
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Name [2]
318966
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In kind from Frankston Hospital
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Address [2]
318966
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Country [2]
318966
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Australia
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Primary sponsor type
Hospital
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Name
Alfred health
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Address
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Country
Australia
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Secondary sponsor category [1]
321415
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Hospital
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Name [1]
321415
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Frankston Hospital
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Address [1]
321415
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Country [1]
321415
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Australia
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Other collaborator category [1]
283523
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Hospital
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Name [1]
283523
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Box Hill Hospital
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Address [1]
283523
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Country [1]
283523
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
317554
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
317554
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
317554
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Australia
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Date submitted for ethics approval [1]
317554
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07/05/2025
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Approval date [1]
317554
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Ethics approval number [1]
317554
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Summary
Brief summary
Perioperative anxiety is common and has implications for an individual’s recovery from surgery and general health outcomes. We will measure anxiety preoperatively and then assess opioid analgesia requirement and recovery (measured by length of hospitalisation)post operatively. We hypothesise that more anxious patients will have more pain after surgery, with poorer recovery and perhaps longer hospital stay.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
141422
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Dr Christopher McGugan Wevill
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Address
141422
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C/O Frankston Hospital, 2 Hastings Rd Frankston Vic 3199
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Country
141422
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Australia
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Phone
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+61 439390865
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Fax
141422
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Email
141422
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[email protected]
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Contact person for public queries
Name
141423
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Christopher McGugan Wevill
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Address
141423
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C/O Frankston Hospital, 2 Hastings Rd Frankston Vic 3199
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Country
141423
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Australia
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Phone
141423
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+61 439390865
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Fax
141423
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Email
141423
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[email protected]
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Contact person for scientific queries
Name
141424
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Christopher McGugan Wevill
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Address
141424
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C/O Frankston Hospital, 2 Hastings Rd Frankston Vic 3199
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Country
141424
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Australia
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Phone
141424
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+61 439390865
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Fax
141424
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Email
141424
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
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.
Download to PDF