Investigating cognitive effects of aromatherapy on people with dementia living in residential care facilities

ISRCTN	ISRCTN86563511
DOI	https://doi.org/10.1186/ISRCTN86563511
Protocol serial number	ECN-04-201
Sponsor	Australian Centre for Complementary Medicine, Education and Research (ACCMER)
Funder	Post graduate funding from Australian Centre for Complementary Medicine, Education and Research (ACCMER) and the School of Natural and Complementary Medicine

Submission date: 09/06/2005
Registration date: 21/09/2005
Last edited: 16/11/2006

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Stephen Myers
Scientific

P.O. Box 157
Lismore
2480
Australia

Phone	+61 (0)2 66 20 3403
Email	smyers@scu.edu.au

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Aromatherapy trial
Study objectives	Twelve weeks of aromatherapy treatment with the active oil blend will show a statistically significant improvement in participants cognitive ability and behavioural characteristics compared to baseline
Ethics approval(s)	Not provided at registration time
Health condition(s) or problem(s) studied	Dementia
Intervention	The 'active' treatment will contain 1 ml 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 1 ml each of Ginger (Zingiber officinalis), Lemongrass (Cymbopogon citratus) and Mandarin (Citrus recticulata) essential oils, diluted in a non-fragranced aqueous cream lotion. The placebo preparation will contain only non-fragranced aqueous cream lotion and will be used during the washout periods. An important purpose of the placebo is to control for the possible effect of touch.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cypress (Cupressus sempervirens), Lime (Citrus latifolia) and Eucalyptus (Eucalyptus globulus)
Primary outcome measure(s)	The primary outcome measure will be the difference in mean baseline and endpoint scores on the standardised Mini-Mental State Examination (MMSE) (Molloy et al., 1991). The MMSE is the standard scale used by aged care facilities for assessing the stage of dementia and cognitive function of their residents. The annual rate of change on the MMSE for people with a base-line score between 7-28 is a decrease of 3.6 points per year, or about 0.9 points per 12 weeks (Swanwick et al., 1998). A typical Alzheimer's drug trial reports a mean MMSE increase over 12 weeks between 0.8 and 2.3 points for a similar population.
Key secondary outcome measure(s)	Secondary outcome measures will be: 1. Difference in baseline, repeated measures and endpoint scores on the Nurses Observation Scale for Geriatric Patients (NOSGER) (Spiegel et al. 1991) 2. Changes in the use of other medications related to cognitive and behavioural functions (for example, anti-depressants, anti-psychotics) 3. Correlation between ability to smell the treatments and end-point scores on MMSE and NOSGER
Completion date	30/09/2005

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	130
Key inclusion criteria	Residents in good health will be invited to participate in the treatment arms of the study if they also comply with the following criteria. They must: 1. Have been living in the nursing home for more than 3 months 2. Be more than 65 years old 3. Already be on an aromatherapy care plan; or deemed by the Director of Care or the care staff to be unlikely to be disturbed by the use of the aromatherapy lotion in place of their normal skin integrity lotion 4. Have English as their first language They must also have: 5. A Mini-Mental State Examination (MMSE) score of 10-26 6. A diagnosis of dementia, short-term memory loss or cognitive impairment that is not caused by any other diagnosis of mental illness 7. Residents with non-acute concomitant diseases may participate if their disease is medically controlled.
Key exclusion criteria	1. Had a myocardial infarction or stroke in previous 3 months 2. Epilepsy 3. Current treatment with anti-cholinesterase or anti-cholinergic drugs 4. Eczema, psoriasis or dermatitis around the neck and shoulders area 5. Known allergy to Eucalyptus, Cypress, Ginger, Lemongrass, Lime or Mandarin essential oils or aqueous cream 6. An adverse reaction to treatment patch-tests given during screening process 7. Vision or hearing impairments that prevent them from undertaking the cognitive test
Date of first enrolment	01/04/2005
Date of final enrolment	30/09/2005

Locations

Countries of recruitment

Australia

Study participating centre

P.O. Box 157

Lismore
2480
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan