Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000515392
Ethics application status
Approved
Date submitted
8/09/2008
Date registered
2/10/2008
Date last updated
9/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of abdominal massage for the relief of constipation for patients receiving palliative care
Scientific title
The effectiveness of abdominal massage for the relief of constipation in patients receiving palliative care
Secondary ID [1] 288104 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
constipation 3653 0
Condition category
Condition code
Other 3821 3821 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Abdominal Massage: The person who has been identified as being constipated and who has been allocated to the intervention group will be will be given (one only) 20 minute abdominal massage by a Registered Nurse qualified in massage therapy. Patients who fail to have their bowels open within a six hour period following abdominal massage, will receive usual care.
Intervention code [1] 3369 0
Treatment: Other
Comparator / control treatment
Usual care consists of a rectal examination to identify the presence or absence of faeces. If faeces are present the patient is given 2 Bisalax enemas (10mgs Bisacodyl in 5 mls) and monitored for 6 hours. In the absence of faeces the patient is given 1 Coloxyl (docusate sodium 100mgs, bisacodyl 10mgs) and 1 Durolax suppository (10mgs bisacodyl) and monitored for 6 hours.
The mode of administration for all enemas and suppositories will be per rectum.
Control group
Active

Outcomes
Primary outcome [1] 4718 0
Stool consistency will be measured using the Bristol Stool Form Scale (Norgine Limited 2000)
Timepoint [1] 4718 0
6 hours post treatment
Primary outcome [2] 4853 0
Observation of time taken for bowels to open will be recorded.
Timepoint [2] 4853 0
Time interval between end of treatment and bowel opening or until 6 hours have elapsed, whichever occurs first.
Secondary outcome [1] 7966 0
Patient satisfaction will be assessed using a self developed 'Patient Satisfaction Survey'. This consists of a 14 point Likert Scale.
Timepoint [1] 7966 0
6 hours post treatment

Eligibility
Key inclusion criteria
constipation
Minimum age
21 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical assessment not suitable for study-Exclusion criteria:
*receiving radio therapy to their abdomen or have received radio therapy to their abdomen in the previous six weeks
*have an intestinal obstruction, either from tumour in the bowel wall itself or from external compression of the bowel by a pelvic or abdominal tumour.
*had abdominal surgery within the last 8 weeks
*have an existing colostomy/iliostomy
*not recommended by the nursing or medical staff for any other reason
*refuse abdominal massage or usual care when they experience constipation
*have difficulty with English comprehension
*unable to give informed consent for any reason

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)
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
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
30/10/2008
Actual
3/03/2009
Date of last participant enrolment
Anticipated
Actual
26/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 3834 0
University
Name [1] 3834 0
Flinders University
Country [1] 3834 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
School of Nursing & Midwifery, Flinders University, GPO Box 2100, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 3443 0
Hospital
Name [1] 3443 0
Repatriation General Hospital
Address [1] 3443 0
216 Daws Road, Daw Park, SA 5041
Country [1] 3443 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5886 0
Waiting for Repatriation General Hospital
Ethics committee address [1] 5886 0
Ethics committee country [1] 5886 0
Australia
Date submitted for ethics approval [1] 5886 0
28/08/2008
Approval date [1] 5886 0
27/10/2008
Ethics approval number [1] 5886 0

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

Contacts
Principal investigator
Name 28908 0
Dr Ann Harrington
Address 28908 0
School of Nursing & Midwifery, Flinders University, GPO Box 2100, Adelaide SA 5001
Country 28908 0
Australia
Phone 28908 0
+8 8201 3483
Fax 28908 0
Email 28908 0
[email protected]
Contact person for public queries
Name 12065 0
Ann Harrington
Address 12065 0
School of Nursing & Midwifery, Flinders University, GPO Box 2100, Adelaide SA 5001
Country 12065 0
Australia
Phone 12065 0
(08) 8201 3483
Fax 12065 0
Email 12065 0
[email protected]
Contact person for scientific queries
Name 2993 0
Ann Harrington
Address 2993 0
School of Nursing & Midwifery, Flinders University, GPO Box 2100, Adelaide SA 5001.
Country 2993 0
Australia
Phone 2993 0
(08) 8201 3483
Fax 2993 0
Email 2993 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.