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Trial registered on ANZCTR


Registration number
ACTRN12612000917831
Ethics application status
Approved
Date submitted
27/08/2012
Date registered
28/08/2012
Date last updated
28/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation into the Benefits of Lavender Oil and Hand Massage as Complementary Therapies on Disruptive Behaviour in People with Dementia.
Scientific title
A Randomized Controlled Clinical trial of Aromatherapy and Hand Massage on Disruptive Behaviour in People with Dementia.
Secondary ID [1] 281096 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disruptive behaviour in people with dementia 287253 0
Condition category
Condition code
Mental Health 287577 287577 0 0
Other mental health disorders
Neurological 287578 287578 0 0
Dementias
Alternative and Complementary Medicine 287579 287579 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention activities are i) Aromatherapy - three sprays of 3% of lavender oil in water on the participant's chest or ii) a combination of aromatherapy and hand massage - 5 minutes of hand massage with 5ml of aqua lotion by trained research assistants. Both activities were given twice a day every day for a period of six weeks (i.e. 84 treatments over 42 days).
Intervention code [1] 285550 0
Behaviour
Comparator / control treatment
Control treatment consisted of three sprays of water mist on the participant's chest twice a day evry day for a period of six weeks (i.e. 84 treatments over 42 days).
Control group
Placebo

Outcomes
Primary outcome [1] 287841 0
Disruptive behaviours - 14 short-item Cohen-Mansfield Agitation Inventory (CMAI).
Timepoint [1] 287841 0
1) Pre-intervention (Baseline)
2) at the end of Week 2
3) at the end of Week 4
4) Completion Intervention - at the end of Week 6
5) Post-Test (6 weeks following the completion of the intervention)
Primary outcome [2] 287842 0
Disruptive behaviours - Revised Memory and Behaviour Problems Checklist (RMBPC)
Timepoint [2] 287842 0
1) Pre-intervention (Baseline)
2) at the end of Week 2
3) at the end of Week 4
4) Completion Intervention - at the end of Week 6
5) Post-Test (6 weeks following the completion of the intervention)
Secondary outcome [1] 298924 0
Cognitive impairment - Mini Mental Status Examination (MMSE)
Timepoint [1] 298924 0
1) Pre-intervention (Baseline)
2) Completion Intervention - at the end of Week 6

Eligibility
Key inclusion criteria
1) Had lived in one of the three participating nursing homes for at least three months
2) Had cognitive function impairment indicative of a dementing condition, e.g. MMSE was 24 out of 30 or below 24 and has the features of Alzheimer’s disease according to DSM-IV (American Psychiatric Association, 1991)
3) Had a two-week documented behavioural history of agitation and aggression in past three months
4) Received current physical or chemical restraint for agitation and aggression including P.R.N. (as required) medication
5) Consent had been given by family or a health-attorney for the resident’s participation
6) Had no allergy to lavender oils
7) Had no recent wound on hands that would interfere with hand massage such as skin tears, laceration, and bruises, red and swollen.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Had a diagnosis of schizophrenia or mental retardation
2) Had no documented behavioural history in the previous three months
3) Was currently hospitalized
4) Was going to be transferred to another residential facility in 3 months
5) MMSE was higher than 24 out of 30.

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)
The care managers selected residents who appeared to fit the research selection criteria and then sent informed consent information to their next of kin. If there was no response, a second posting of information was sent as a reminder three weeks later.

A person not involved with data collection conducted the randomization process using a random number table (restricted randomization) in the care residential facility to allocate participants into three groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number table (restricted randomization) was used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285885 0
Government body
Name [1] 285885 0
Queensland Nursing Council
Address [1] 285885 0
GPO Box 2928
Brisbane
QLD 4000
Country [1] 285885 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road
Nathan
QLD 4111
Country
Australia
Secondary sponsor category [1] 284710 0
None
Name [1] 284710 0
Address [1] 284710 0
Country [1] 284710 0
Other collaborator category [1] 277043 0
Other Collaborative groups
Name [1] 277043 0
RSL Care
Address [1] 277043 0
301 Wickham Street
Fortitude Valley
QLD 4006
Country [1] 277043 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287914 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 287914 0
170 Kessels Road
Nathan
QLD 4111
Ethics committee country [1] 287914 0
Australia
Date submitted for ethics approval [1] 287914 0
Approval date [1] 287914 0
02/09/2005
Ethics approval number [1] 287914 0
NRS/25/05/HREC

Summary
Brief summary
This study investigated the effect of Aromatherapy (3% lavender angustifolia mist) with or without hand massage (five minutes with aqua cream) on disruptive behaviour in people with dementia living in residential aged care facilities (RACF).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34622 0
Address 34622 0
Country 34622 0
Phone 34622 0
Fax 34622 0
Email 34622 0
Contact person for public queries
Name 17869 0
Professor Wendy Moyle
Address 17869 0
170 Kessels Road
Nathan
QLD 4111
Country 17869 0
Australia
Phone 17869 0
+61 (0) 7 3735 5526
Fax 17869 0
Email 17869 0
w.moyle@griffith.edu.au
Contact person for scientific queries
Name 8797 0
Professor Wendy Moyle
Address 8797 0
170 Kessels Road
Nathan
QLD 4111
Country 8797 0
Australia
Phone 8797 0
+61 (0) 7 3735 5526
Fax 8797 0
Email 8797 0
w.moyle@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary