Trial Review

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
ACTRN12612000361808
Ethics application status
Approved
Date submitted
24/03/2012
Date registered
29/03/2012
Date last updated
29/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reduction of sternotomy pain with “self-hug"
Scientific title
In adult patients undergoing a cardiac procedure needing a sternotomy, can “self-hug" reduce post-operative sternotomy pain?
Secondary ID [1] 279966 0
Nil
Universal Trial Number (UTN)
U1111-1128-2813
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain post sternotomy 285883 0
Condition category
Condition code
Cardiovascular 286073 286073 0 0
Other cardiovascular diseases
Surgery 286074 286074 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Standard care is to protect the sternotomy wound with the hands cross in front of the chest with a pillow.
From day 2-5 post-operatively all patients in the study are asked to rate the sternotomy pain with the following 2 manoeuvres.
first 3 deep breaths and subsequent coughs with the cross-chest method (support/compression of the sternotomy wound with crossed hands in front of the chest with a pillow) vs 3 deep breaths and subsequent coughs with the "self-hug" method (arms across the chest pulling together the shoulder and shoulder blade pulling with the hands on either side.
This is done once in the morning and once in the afternoon. In the afternoon the order is reversed with the "self-hug" method first followed by the cross-chest method.
Intervention code [1] 284303 0
Treatment: Other
Comparator / control treatment
Sternotomy patients receiving standard care supporting the sternotomy wound with the cross-chest method as described under Description of intervention.
Control group
Active

Outcomes
Primary outcome [1] 286807 0
Reduced pain with activity (deep breath and coughing) in about 50% of the patients.
Pain is assess on a numerical scale 1-10.
Timepoint [1] 286807 0
From day 2 to 5 post-operatively the pain, on 3 deep breaths and subsequent coughs, will be assess once in the morning and once in the afternoon.
Secondary outcome [1] 296704 0
Nil
Timepoint [1] 296704 0
Nil

Eligibility
Key inclusion criteria
All adult patients undergoing a cardiac procedure needing a sternotomy
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ICU stay longer than 2 days,
Return to theatre and/or re-do sternotomies,
Post-operative confusion

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)
All coming patient for cardiac surgery needing a sternotomy will be asked to partake in the study untill 40 patients are enrolled.
Each patient will be asked to perform and give a pain score (numerical) with the cross-chest and self-hug method.
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
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284959 0
Hospital
Name [1] 284959 0
Sir Charles Gairdner Hospital
Country [1] 284959 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Ave
Nedlands
WA6009
Country
Australia
Secondary sponsor category [1] 283829 0
None
Name [1] 283829 0
Address [1] 283829 0
Country [1] 283829 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286968 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 286968 0
Hospital Avenue
Nedlands
WA6009
Ethics committee country [1] 286968 0
Australia
Date submitted for ethics approval [1] 286968 0
25/11/2011
Approval date [1] 286968 0
21/01/2012
Ethics approval number [1] 286968 0
2011-120

Summary
Brief summary
A sternotomy (cut through the breastbone) for heart surgery is associated with some pain. The pain can be increased with activities like mobilisation but also deep breathing and coughing. We intend to assess whether the pain is less with self-hugging the chest (arms around the shoulder pulling them together) compared to the standard method of compression of the chest with the hands crossed over a pillow in front of the chest.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33798 0
Address 33798 0
Country 33798 0
Phone 33798 0
Fax 33798 0
Email 33798 0
Contact person for public queries
Name 17045 0
L Sanders
Address 17045 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA6009
Country 17045 0
Australia
Phone 17045 0
+61 8 9346 3333
Fax 17045 0
Email 17045 0
[email protected]
Contact person for scientific queries
Name 7973 0
L Sanders
Address 7973 0
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA6009
Country 7973 0
Australia
Phone 7973 0
+61 8 9346 3333
Fax 7973 0
Email 7973 0
[email protected]

No information has been provided regarding IPD availability


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.