Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000191099
Ethics application status
Approved
Date submitted
24/02/2010
Date registered
3/03/2010
Date last updated
3/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating stress reduction therapy in cardiothoracic surgical patients.
Scientific title
Evaluating stress reduction therapy in cardiothoracic surgical patients using massage therapy or standard care ('quite time').
Secondary ID [1] 1436 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood pressure, heart rate, respiratory rate, pain, anxiety and tension. 256881 0
Condition category
Condition code
Alternative and Complementary Medicine 257029 257029 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two 20 minute swedish massage therapy sessions, performed between days 3 and 6 post-operative. 20 minutes of hands-on massage will be performed and focused on the areas requested by the patient. Depending upon the area identified by the patient to be massaged, the gentle massage procedure may consist of; back and neck, arm and hands, or foot, leg and hips.
Intervention code [1] 256089 0
Treatment: Other
Comparator / control treatment
Two 20 minute 'quiet time' (standard care) sessions, performed between dasy 3 and 6 post-operative. Where a sign is placed on the door or curtain, stating that patient is not be disturbed for 20 minutes. The patient is then left alone in the room and asked to refrain from reading or watching television during the 20 minutes 'quite time'.
Control group
Active

Outcomes
Primary outcome [1] 257917 0
Compare the level of pain, anxiety and tension before and after a 20 minute massage therapy session provided by a trained therapist between days 3 and 6 post cardiac surgery. Assessment tools used; blood pressure, heart rate, respiratory rate, a visual analogue scale and a Short Form (SF36) questionaire.
Timepoint [1] 257917 0
before and after each 20 minute treatment session.
Primary outcome [2] 257918 0
Compare the level of pain, anxiety and tension before and after a 20 minute massage therapy session provided by a trained therapist between days 3-6 post cardiac surgery. Assessment tools used; blood pressure, heart rate, respiratory rate, a visual analogue scale and a SF36.
Timepoint [2] 257918 0
before and after each 20 minute treatment session.
Primary outcome [3] 257919 0
Compare the level of pain, anxiety and tension before and after 20 minutes of quiet time provided between days 3-6 post-operative. Assessment tools used; blood pressure, heart rate, respiratory rate, a visual analogue scale and a SF36.
Timepoint [3] 257919 0
before and after each 20 minute treatment session.
Primary outcome [4] 257920 0
Identify the difference in amount of change in pain, anxiety and tension for those patients that received massage therapy versus those patients that received 'quiet time' for two periods after surgery. Assessment tools used; blood pressure, heart rate, respiratory rate, a visual analogue scale and a SF36.
Timepoint [4] 257920 0
after 1 year when trial completed.
Secondary outcome [1] 263400 0
Identify change in blood pressure, heart rate and respiratory rate before and after massage therapy compared to standard care. Mechanical vital sign machine will be used to assess the above.
Timepoint [1] 263400 0
before and after each 20 minute treatment session.
Secondary outcome [2] 263401 0
Describe patient reported areas of discomfort before and after massage therapy. Assessed by massage therapist using a diagramatic representation of the body.
Timepoint [2] 263401 0
before and after each 20 minute treatment session.
Secondary outcome [3] 263402 0
Report overall satisfaction with the experience of massage therapy. Assessed using SF36 and VAS (visual analogue scale).
Timepoint [3] 263402 0
after each 20 minute treatment session
Secondary outcome [4] 263403 0
Identify challenges that are encountered by nursing staff and massage therapists while providing this service. Methods used will include a focus group session as well as written feedback by massage therapist post each treatment session.
Timepoint [4] 263403 0
after 1 year when trial completed

Eligibility
Key inclusion criteria
Patients scheduled for coronary artery bypass surgery or cardiac valve surgery or both.
Patients that have given consent to participate.
Patients who are medically able to participate in massage therapy between days 3-6 post-operatively.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with chronic pain or a psychiatric history will be excluded from the study.
Patients with prolonged bleeding or intubation greater than 24 hours.
Patients that decide not to participate post operatively.
Patients that are not alert enough to participate in the data collection.
Patients that would not be able to get a massage due to complexity of medical care including active cellulitis, phlebitis, complex wounds and multiple drains.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All elective cardiac surgery patients presenting at the preadmission clinic are approached by the Research nurse and invited to participate in the study if eligible. Allocation is not concealed. Patient are given study information and consent forms. Consenting participants are allocated to either massage therapy or standard care using computor generated number tables. Patients are unaware regarding what group they are allocated too.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computor generated randomised numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256572 0
Self funded/Unfunded
Name [1] 256572 0
Country [1] 256572 0
Australia
Primary sponsor type
Individual
Name
Professor Franklin Rosenfeldt
Address
The Alfred
Cardiothoracic Surgery Unit
Commercial Road
PO Box 315
Prahran
VIC 3181
Country
Australia
Secondary sponsor category [1] 255866 0
None
Name [1] 255866 0
Address [1] 255866 0
Country [1] 255866 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258606 0
Human Reasearch Commitee, The Alfred
Ethics committee address [1] 258606 0
Ethics committee country [1] 258606 0
Australia
Date submitted for ethics approval [1] 258606 0
04/02/2009
Approval date [1] 258606 0
10/03/2009
Ethics approval number [1] 258606 0
27/09/2010

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30877 0
Address 30877 0
Country 30877 0
Phone 30877 0
Fax 30877 0
Email 30877 0
Contact person for public queries
Name 14124 0
Cathy Reardon
Address 14124 0
The Alfred PO Box 315
VIC 3181
Country 14124 0
Australia
Phone 14124 0
+61 3 90762679
Fax 14124 0
Email 14124 0
[email protected]
Contact person for scientific queries
Name 5052 0
Professor Franklin Rosenfeldt
Address 5052 0
The Alfred PO Box 315
VIC 3181
Country 5052 0
Australia
Phone 5052 0
+61 3 90763691
Fax 5052 0
Email 5052 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.