Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000569202
Ethics application status
Approved
Date submitted
10/07/2009
Date registered
13/07/2009
Date last updated
9/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A controlled trial of topically administered Lavender essential oil as a treatment of behavioural symptoms in dementia.
Scientific title
A controlled trial of topically administered Lavender essential oil as a treatment of behavioural symptoms in dementia.
Secondary ID [1] 283736 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to severe dementia 237178 0
Condition category
Condition code
Mental Health 237503 237503 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A aged care facility staff member will apply 1ml of pure essential lavender oil to the participant's forearm on 3 occasions over one week. In the following week the participant will be exposed to the comparator treatment on 3 occasions.
Intervention code [1] 236886 0
Behaviour
Comparator / control treatment
A aged care facility staff member will apply 1ml of Jojoba (neutral)/placebo oil to the participant's forearm on three occasions over one week. In the following week the participant will be exposed to the active treatment on 3 occasions.
Control group
Placebo

Outcomes
Primary outcome [1] 238313 0
One or two physically agitated behaviours will be recorded as present or absent during one minute intervals over a 90 minute period. The target behaviours will be established by interviewing an aged care faciltity staff member who is familiar to the participant using the Cohen Mansfield Agitation Inventory (CMAI).
Timepoint [1] 238313 0
Observations will commence 30 minutes prior to intervention and continue for 60 minutes post intervention. For each minute the presence or absence of the chosen target behaviours will be recorded.
Secondary outcome [1] 244704 0
Affect
Timepoint [1] 244704 0
Observations will commence 30 minutes prior to intervention and continue for 60 minutes post intervention. For each minute the predominant type of affect is recorded.
Secondary outcome [2] 244705 0
Physical and verbal agitation
Timepoint [2] 244705 0
At the end of each week over the 2 week intervention period, the frequency of physical and/or verbal agitation will be noted by an interview with a staff member from the aged care facility using the CMAI.

Eligibility
Key inclusion criteria
A participant needs to be in the aged care facility for at least 3 months, have a history of dementia, and be stable re: medical, psychologicial and medication regime. Also agitated (physical behaviours) should occur several times an hour on a daily basis and are not associated with nursing activities ie Activities of Daily Living (ADLs). The behaviours are also not due to pain, physical illness, depression or psychosis.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The presence of acutely life threatening illness. The agitated behaviours are dangerous to researchers.

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)
We will use an efficient, economical design with random allocation to treatment or control conditions followed by cross-over.
The allocation of the treatment arms will conducted by an independent senior researcher who is not involved in the determining a subject's eligibility for inclusion to the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation is conducted by an experienced, independent Research Fellow who is not associated with the eligibility, observations or outcomes of the study. Participants are exposed to lavender or control condition in a random order (A-B or B-A). The senior researcher will generate random numbers using Microsoft Excel Random Generator software. When the participant falls due for randomisation she will allocate to sequence A-B if the number is even and B-A if odd.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
To ensure the staff member is blinded to the smell of the condition, the facility staff member will apply a masking cream to his/her top lip and wear a nose clip before applying the oil. The researchers will also be blinded to the condition by ensuring they also regularly apply a masking cream prior to and during the observation period.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/06/2009
Actual
3/07/2009
Date of last participant enrolment
Anticipated
Actual
21/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237281 0
Government body
Name [1] 237281 0
National Health & Medical Research Council
Country [1] 237281 0
Australia
Funding source category [2] 237282 0
Other Collaborative groups
Name [2] 237282 0
Dementia Collaborative Research Centre (DCRC)
Country [2] 237282 0
Australia
Funding source category [3] 237283 0
Charities/Societies/Foundations
Name [3] 237283 0
Jack Brockhoff Foundation
Country [3] 237283 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road
Cheltenham
Victoria 3192
Country
Australia
Secondary sponsor category [1] 236777 0
Hospital
Name [1] 236777 0
Southern Health
Address [1] 236777 0
246 Clayton Road
Clayton
Victoria 3168
Country [1] 236777 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239379 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 239379 0
Ethics committee country [1] 239379 0
Australia
Date submitted for ethics approval [1] 239379 0
Approval date [1] 239379 0
24/04/2008
Ethics approval number [1] 239379 0
08013A
Ethics committee name [2] 239380 0
Peninsula Health Human Research Ethics committee
Ethics committee address [2] 239380 0
Ethics committee country [2] 239380 0
Australia
Date submitted for ethics approval [2] 239380 0
03/06/2009
Approval date [2] 239380 0
Ethics approval number [2] 239380 0
2009-25
Ethics committee name [3] 239394 0
Alfred Health
Ethics committee address [3] 239394 0
Ethics committee country [3] 239394 0
Australia
Date submitted for ethics approval [3] 239394 0
01/08/2009
Approval date [3] 239394 0
Ethics approval number [3] 239394 0
Ethics committee name [4] 290287 0
St Vincent's Hospital Human Research Ethics Committee - D
Ethics committee address [4] 290287 0
Ethics committee country [4] 290287 0
Australia
Date submitted for ethics approval [4] 290287 0
Approval date [4] 290287 0
03/03/2010
Ethics approval number [4] 290287 0
160/09
Ethics committee name [5] 290288 0
Eastern Health Research and Ethics Committee
Ethics committee address [5] 290288 0
Ethics committee country [5] 290288 0
Australia
Date submitted for ethics approval [5] 290288 0
Approval date [5] 290288 0
27/10/2010
Ethics approval number [5] 290288 0
E16/1011

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

Contacts
Principal investigator
Name 29860 0
Prof Daniel O'Connor
Address 29860 0
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road
Cheltenham Victoria
3192
Country 29860 0
Australia
Phone 29860 0
613 9265 1700
Fax 29860 0
613 9265 1711
Email 29860 0
[email protected]
Contact person for public queries
Name 13107 0
Barbara Eppingstall
Address 13107 0
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road
Cheltenham
Victoria
3192
Country 13107 0
Australia
Phone 13107 0
613 9265 1706
Fax 13107 0
613 9265 1711
Email 13107 0
[email protected]
Contact person for scientific queries
Name 4035 0
Professor Daniel O'Connor
Address 4035 0
Aged Mental Health Research Unit
Kingston Centre
Warrigal Road
Cheltenham
Victoria
3192
Country 4035 0
Australia
Phone 4035 0
613 9265 1700
Fax 4035 0
613 9265 1711
Email 4035 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
SourceTitleYear of PublicationDOI
EmbaseA randomized, controlled cross-over trial of dermally-applied lavender (Lavandula angustifolia) oil as a treatment of agitated behaviour in dementia.2013https://dx.doi.org/10.1186/1472-6882-13-315
N.B. These documents automatically identified may not have been verified by the study sponsor.