ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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 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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Coronary artery bypass graft surgery

Condition category

Condition code

Cardiovascular

Coronary heart disease

Physical Medicine / Rehabilitation

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]

Not applicable

Comparator / control treatment

Uncontrolled

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

Physiotherapists' perception on adequate pain management post CABG surgery. Outcome is assessed by answering pain management specific questions.

Timepoint [2]

Respondents are given 1 month to complete the questionnaire. The question was formulated specifically for this study

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Liverpool Hospital

Address [1]

Elizabeth Street
Liverpool
NSW, 2170

Country [1]

Australia

Primary sponsor type

Individual

Name

Serena Hong

Address

Physiotherapy Department
Liverpool Hospital
Elizabeth Street
Liverpool,
NSW, 2170

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Liverpool Hospital

Address [1]

Elizabeth Street,
Liverpool
NSW 2170

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Professor Jennifer Alison

Address [1]

University of Sydney
East Street
Lidcombe
NSW, 1825

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney

Ethics committee address [1]

Level 6, Jane Foss Russell
The University of Sydney
NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/11/2013

Approval date [1]

07/01/2014

Ethics approval number [1]

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

Ms Serena Hong

Address

Physiotherapy Department
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170

Country

Australia

Phone

+61 2 8738 4703

Fax

serena.hong@sswahs.nsw.gov.au

Contact person for public queries

Name

Serena Hong

Address

Physiotherapy Department
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170

Country

Australia

Phone

+61 2 8738 4703

Fax

serena.hong@sswahs.nsw.gov.au

Contact person for scientific queries

Name

Serena Hong

Address

Physiotherapy Department
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170

Country

Australia

Phone

+61 2 87384703

Fax

serena.hong@sswahs.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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