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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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
Alternative and Complementary Medicine 287579 287579 0 0
Other alternative and complementary medicine

Study type
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
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
QLD 4000
Country [1] 285885 0
Primary sponsor type
Griffith University
170 Kessels Road
QLD 4111
Secondary sponsor category [1] 284710 0
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

Ethics approval
Ethics application status
Ethics committee name [1] 287914 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 287914 0
170 Kessels Road
QLD 4111
Ethics committee country [1] 287914 0
Date submitted for ethics approval [1] 287914 0
Approval date [1] 287914 0
Ethics approval number [1] 287914 0

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

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
QLD 4111
Country 17869 0
Phone 17869 0
+61 (0) 7 3735 5526
Fax 17869 0
Email 17869 0
Contact person for scientific queries
Name 8797 0
Professor Wendy Moyle
Address 8797 0
170 Kessels Road
QLD 4111
Country 8797 0
Phone 8797 0
+61 (0) 7 3735 5526
Fax 8797 0
Email 8797 0

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