Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000290695
Ethics application status
Approved
Date submitted
26/08/2005
Date registered
5/09/2005
Date last updated
21/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating cognitive effects of aromatherapy on people with dementia
living in residential care facilities
Scientific title
Investigating cognitive effects of aromatherapy on people with dementia
living in residential care facilities
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 378 0
Condition category
Condition code
Neurological 448 448 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The "active" treatment will contain 1mL each of Cypress (Cupressus sempervirens), Lime (Citrus latifolia) and Eucalyptus (Eucalyptus globulus) essential oils, diluted in a non-fragranced aqueous cream lotion. The "inactive" preparation will contain 1mL each of Ginger (Zingiber officinalis, Lemongrass (Cymbopogon citratus) and Mandarin (Citrus recticulata) essential oils diluted in a non-fragranced aqueous cream lotion.
Intervention code [1] 274 0
Treatment: Other
Comparator / control treatment
The placebo preparation will contain only non-fragranced aqueous cream lotion.
Control group
Placebo

Outcomes
Primary outcome [1] 510 0
The 30 point Mini-Mental State Examination (MMSE)
Timepoint [1] 510 0
Measured at week -2, baseline, week 12 and week 16
Secondary outcome [1] 1094 0
Nurses’ Observation Scale for Geriatric Patients (NOSGER).
Timepoint [1] 1094 0
Difference in baseline, repeated measures and endpoint scores.
Secondary outcome [2] 1095 0
Changes in the use of other medications related to cognitive and behavioural functions (for example, anti-depressants, anti-psychotics).
Timepoint [2] 1095 0
Secondary outcome [3] 1096 0
Short Form 12 Quality of Life Scale.
Timepoint [3] 1096 0
Difference in baseline and end-point.

Eligibility
Key inclusion criteria
During the initial screening interview, potential participants will be invited to participate in the treatment arms of the study if they comply with the following criteria: They must have been resident in the nursing home for more than 3 months. Have an MMSE score of 25 or less, and be considered to have some degree of dementia by nursing staff and or diagnosis by geriatrician. Be in good health or have any concomitant diseases (such as hypertension, congestive heart failure, non-insulin-dependent diabetes mellitus and thyroid disorders) under control.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Treatments were allocated by writing 1,2 placebo on slips of paper, the participant numbers were on slips of paper. Allocation was made by drawing alternate numbers and names from separate containers. The bottles of lotion were labelled with the participants number by an independent researcher
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatments were allocated by writing 1,2 placebo on slips of paper, the participant numbers were on slips of paper. Allocation was made by drawing alternate numbers and names from separate containers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 498 0
Self funded/Unfunded
Name [1] 498 0
Country [1] 498 0
Primary sponsor type
University
Name
ACCMER
Address
Country
Australia
Secondary sponsor category [1] 407 0
None
Name [1] 407 0
none
Address [1] 407 0
Country [1] 407 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1476 0
Southern Cross university Human Research Ethics Committee
Ethics committee address [1] 1476 0
Ethics committee country [1] 1476 0
Australia
Date submitted for ethics approval [1] 1476 0
Approval date [1] 1476 0
Ethics approval number [1] 1476 0
Ethics committee name [2] 1477 0
University of Queensland Human Research Ethics Committee
Ethics committee address [2] 1477 0
Ethics committee country [2] 1477 0
Australia
Date submitted for ethics approval [2] 1477 0
Approval date [2] 1477 0
Ethics approval number [2] 1477 0

Summary
Brief summary
The study design was a randomised, controlled trial. Repeated measures were taken at baseline, 3 points during treatment, and after a wash-out period at the end of the trial. The participants and the person doing the cognitive testing and data analysis were blinded to the treatment allocation, and the staff administering the treatment were blinded as to which of the treatments was the active. The trial will be carried out in parallel groups, with staggered starting times to allow adequate time for the cognitive testing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36077 0
Address 36077 0
Country 36077 0
Phone 36077 0
Fax 36077 0
Email 36077 0
Contact person for public queries
Name 9463 0
Professor Stephen Myers
Address 9463 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 9463 0
Australia
Phone 9463 0
+61 2 66203403
Fax 9463 0
+61 2 66203307
Email 9463 0
[email protected]
Contact person for scientific queries
Name 391 0
Joan O'Connor
Address 391 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 391 0
Australia
Phone 391 0
+61 2 66203649
Fax 391 0
+61 2 66203307
Email 391 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.