Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000050550
Ethics application status
Approved
Date submitted
19/12/2014
Date registered
22/01/2015
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Date results information initially provided
21/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pain in post coronary artery bypass graft surgery patients: perceptions of physiotherapists in Australian and New Zealand hospitals
Scientific title
Pain in post coronary artery bypass graft surgery patients: perceptions of physiotherapists in Australian and New Zealand hospitals
Secondary ID [1] 285866 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery bypass graft surgery 293779 0
Condition category
Condition code
Cardiovascular 294085 294085 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 294198 294198 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study will use a questionnaire that will be sent to all private and public hospitals who provide cardiothoracic surgery in Australia and New Zealand. Physiotherapists who treat patients post coronary artery bypass graft surgery in these hospitals will be invited to participate in the study

The aims of the questionnaire are to determine:1. How much pain do physiotherapists believe post coronary bypass graft surgery patients are experiencing each postoperative day? 2. Do they believe patients’ pain management is adequate? 3. Do physiotherapists believe patients pain limit their walking abilities post CABG? 4. The basis for future research regarding pain management and physiotherapy management post CABG

The questionnaire is to be returned after 1 month after it is mailed out. If the questionnaire is not returned after 1 month, respondents will be invited again to participate in the study
Intervention code [1] 290844 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293870 0
Amount of pain physiotherapists believe post coronary artery bypass graft surgery (CABG) patients are experiencing each postoperative day. Outcome will be measure with visual analogue scale for each postoperative day.
Timepoint [1] 293870 0
Outcome is assessed up to postoperative day 4. The pain rating is scored as a general perception of all patients they treat per postoperative day. Respondents are given 1 month to complete the questionnaire.
Primary outcome [2] 293871 0
Physiotherapists' perception on adequate pain management post CABG surgery. Outcome is assessed by answering pain management specific questions.
Timepoint [2] 293871 0
Respondents are given 1 month to complete the questionnaire. The question was formulated specifically for this study
Secondary outcome [1] 312048 0
Physiotherapists' perception or belief whether pain limits walking abilities post CABG surgery. Outcome is assessed by answering question that is specific to limitation to walking due to pain.
Timepoint [1] 312048 0
Respondents are given one month to complete the questionnaire. The question was formulated specifically for this study.

Eligibility
Key inclusion criteria
Physiotherapists who treat patients post CABG surgery in public and private hospitals within Australia and New Zealand
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-physiotherapists, physiotherapists who do not treat patients post CABG surgery

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Sample size of 54 hospitals that perform CABG surgery have been identified. We anticipate the return rate to be >80% i.e. 43 hospitals.
Descriptive statistical analysis (mean and standard deviation) will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/01/2014
Actual
23/01/2014
Date of last participant enrolment
Anticipated
Actual
22/10/2014
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
43
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 6554 0
New Zealand
State/province [1] 6554 0

Funding & Sponsors
Funding source category [1] 290445 0
Hospital
Name [1] 290445 0
Liverpool Hospital
Country [1] 290445 0
Australia
Primary sponsor type
Individual
Name
Serena Hong
Address
Physiotherapy Department
Liverpool Hospital
Elizabeth Street
Liverpool,
NSW, 2170
Country
Australia
Secondary sponsor category [1] 289151 0
Hospital
Name [1] 289151 0
Liverpool Hospital
Address [1] 289151 0
Elizabeth Street,
Liverpool
NSW 2170
Country [1] 289151 0
Australia
Other collaborator category [1] 278269 0
Individual
Name [1] 278269 0
Professor Jennifer Alison
Address [1] 278269 0
University of Sydney
East Street
Lidcombe
NSW, 1825
Country [1] 278269 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292123 0
University of Sydney
Ethics committee address [1] 292123 0
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006
Ethics committee country [1] 292123 0
Australia
Date submitted for ethics approval [1] 292123 0
17/11/2013
Approval date [1] 292123 0
07/01/2014
Ethics approval number [1] 292123 0
2013/1016

Summary
Brief summary
Physiotherapy treatment for patients undergoing Coronary artery bypass graft (CABG) surgery involves pre operative education, and post-operative breathing exercises and coughing, early mobilisation and musculoskeletal exercises to prevent pulmonary complication and to aid in discharge from the hospital and return to activity in timely manner.
Pain post CABG may be from surgical trauma, multiple cannulas including chest drains, and harvesting of internal mammary arteries (IMAs). Ferguson et al reported that health professionals often underestimate pain the post CABG patients experience. The most common area the patients experience pain post CABG is the chest, where there is surgical wound, and also where chest drains have been.
Studies have shown that CABG patients have limited ability to cough and perform breathing exercises, general activity and ambulation due to severe pain post surgery.
There have been six surveys studying physiotherapy practice in Australia and New Zealand, Sweden, the UK and Canada, however, none of these surveys provided information on physiotherapists’ perception of patients’ pain post CABG, or whether physiotherapists believed pain was a limiting factor for patients to reach walking milestone and what guidelines were used to establish milestones for distance to mobilise patients
This study will enable the investigators to collect data on physiotherapists’ perception of CABG patients’ pain post surgery in Australian and New Zealand hospitals. The survey will also identify whether physiotherapists believe pain limits patients walking distance and whether they believe pain management post CABG is adequate.

Hypothesis: Physiotherapists perceive that patients undergoing CABG surgery experience significant pain, therefore it impacts on their walking distance in Australia and New Zealand hospitals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53610 0
Ms Serena Hong
Address 53610 0
Physiotherapy Department
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170
Country 53610 0
Australia
Phone 53610 0
+61 2 8738 4703
Fax 53610 0
Email 53610 0
[email protected]
Contact person for public queries
Name 53611 0
Ms Serena Hong
Address 53611 0
Physiotherapy Department
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170
Country 53611 0
Australia
Phone 53611 0
+61 2 8738 4703
Fax 53611 0
Email 53611 0
[email protected]
Contact person for scientific queries
Name 53612 0
Ms Serena Hong
Address 53612 0
Physiotherapy Department
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170
Country 53612 0
Australia
Phone 53612 0
+61 2 87384703
Fax 53612 0
Email 53612 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
sharing De-identified individual participant data has not been approved by the ethics


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Hong, S., Milross, M., & Alison, J. (2018). Physio... [More Details]

Documents added automatically
No additional documents have been identified.