Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000863730
Ethics application status
Approved
Date submitted
2/06/2022
Date registered
17/06/2022
Date last updated
28/07/2024
Date data sharing statement initially provided
17/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain Tracker App: A study to assess the validity of using a new iPhone application to document pain and pain relief usage in adult patients undergoing orthopaedic surgery.
Scientific title
Pain Tracker App: An investigator-initiated study to assess the validity of using a new iPhone application to document pain in patients undergoing orthopaedic surgery.
Secondary ID [1] 307272 0
None
Universal Trial Number (UTN)
U1111-1277-9686
Trial acronym
PTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orthopaedic surgery 326197 0
Postoperative pain 326198 0
Opioid usage 326199 0
Orthopaedic surgery 326587 0
Condition category
Condition code
Anaesthesiology 323500 323500 0 0
Pain management
Musculoskeletal 323831 323831 0 0
Other muscular and skeletal disorders
Surgery 323832 323832 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible and consenting participants will be asked to record their pain scores using three different scales, the Numerical Rating Scale (NRS), Visual Analog Scale (VAS) and on the Pain Tracker App, on the Pain Level Recording Form. The NRS and VAS are current standard of care. The Pain Tracker App will be on the researcher or surgeons phone, this device will be handed to the participant who will rate their pain using the App. Once completed, the researcher will transfer the recorded pain score provided by the App onto the Pain Level Recording Form and then exit the App without saving any details. The Pain Tracker App will record and hold no patient details. The participant will also be asked which scale they preferred to use and this will also be recorded on the Pain Level Recording Form.
Intervention code [1] 323710 0
Treatment: Devices
Comparator / control treatment
As this project aims to validate the Pain Tracker App there will be no control group i.e. this is an uncontrolled study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331250 0
This primary outcome of this study will be to compare the new Pain Tracker App against the 11-point VAS measurement for pain, currently the standard of pain measurement care at Epworth healthcare.
Timepoint [1] 331250 0
The pain measurements will be collected at least twice daily (patient is free to enter as many times per day as they wish) immediately following surgery. This will occur until the follow up appointment, which is generally 2-6 weeks following surgery.
Secondary outcome [1] 409305 0
Assess patient preference when using the three pain recording scales. Participants will be asked which method they preferred to use when measuring pain.
Timepoint [1] 409305 0
This will be collected on ward review post orthopaedic surgery.
Secondary outcome [2] 410930 0
Compare the OME dosage for participants in the 12 hours prior to reporting in Pain App against the report pain level collected on the Pain Level Recording Form.
Timepoint [2] 410930 0
This will be collected on ward review post orthopaedic surgery.

Eligibility
Key inclusion criteria
Patients may be included in the study if all the following criteria are met:
1. Have decided to proceed with total joint arthroplasty, foot or ankle surgery.
2. Be willing to enter their pain levels with the researcher or surgeon post surgery.
3. Capable of understanding and providing written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical power analysis was undertaken using the method of Zou (2012), implemented in R 4.1 (R Foundation for Statistical Computing, Vienna, 2021). Agreement between instruments such as the app and the standard measure of pain (VAS) is generally measured by the intraclass correlation coefficient (ICC). For an expected minimum ICC of 0.80, the lower limit of a 95% one-sided confidence interval to be no lower than 0.70, and with 80% statistical power, a sample size of 117 patients would be required. Allowing for 10% attrition, (117/0.90) = 130 patients would be required. Statistical analyses will include graphic and descriptive summaries, Bland-Altman plots and ICCs, employed in our previous studies.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/04/2024
Actual
19/02/2024
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
130
Accrual to date
55
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22312 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 37473 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 311359 0
Charities/Societies/Foundations
Name [1] 311359 0
Epworth Medical Foundation
Country [1] 311359 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Epworth Medical Foundation
Address
32 Erin St
Richmond
Victoria
3121
Country
Australia
Secondary sponsor category [1] 312987 0
Charities/Societies/Foundations
Name [1] 312987 0
Australian Orthopaedic Association
Address [1] 312987 0
Level 26, 201 Kent Street, Sydney NSW 2000
Country [1] 312987 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310852 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 310852 0
Level 2
i Block
Monash Medical Centre
246 Clayton Rd
Clayton
Victoria
3168
Ethics committee country [1] 310852 0
Australia
Date submitted for ethics approval [1] 310852 0
31/03/2022
Approval date [1] 310852 0
01/06/2022
Ethics approval number [1] 310852 0
RES-22-0000-230L

Summary
Brief summary
This is an investigator-initiated single-centre, prospective data collection study to assess the validity of using a new iPhone application to document pain in patients undergoing orthopaedic surgery. Eligible and consenting participants will be asked to record their pain scores using three different scales, the NRS, VAS and on the Pain Tracker App, on the Pain Level Recording Form. The NRS and VAS are current standard of care. The Pain Tracker App will be on the researcher or surgeons phone, this device will be handed to the participant who will rate their pain using the App. Once completed, the researcher will transfer the recorded pain score provided by the App onto the Pain Level Recording Form and then exit the App without saving any details. The Pain Tracker App will record and hold no patient details. The participant will also be asked which scale they preferred to use and this will also be recorded on the Pain Level Recording Form.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119094 0
Dr Andrew Beischer
Address 119094 0
Epworth HealthCare Centre
Suite 6.3
32 Erin st
Richmond
Victoria
3121
Country 119094 0
Australia
Phone 119094 0
+610394289944
Fax 119094 0
Email 119094 0
[email protected]
Contact person for public queries
Name 119095 0
Andrew Beischer
Address 119095 0
Epworth HealthCare Centre
Suite 6.3
32 Erin st
Richmond
Victoria
3121
Country 119095 0
Australia
Phone 119095 0
+610394289944
Fax 119095 0
Email 119095 0
[email protected]
Contact person for scientific queries
Name 119096 0
Andrew Beischer
Address 119096 0
Epworth HealthCare Centre
Suite 6.3
32 Erin st
Richmond
Victoria
3121
Country 119096 0
Australia
Phone 119096 0
+610394289944
Fax 119096 0
Email 119096 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be shared as this is considered a breach of privacy and data will only be published as an aggregate rather than individual participant responses.


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.