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ISRCTN
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ISRCTN86563511
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ClinicalTrials.gov identifier
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Public title
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Investigating cognitive effects of aromatherapy on people with dementia living in residential care facilities
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Scientific title
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Acronym
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Aromatherapy trial
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Serial number at source
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ECN-04-201
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Study hypothesis
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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
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Lay summary
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Ethics approval
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Not provided at registration time
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Study design
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Randomised controlled trial
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Dementia
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/04/2005
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Anticipated end date
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30/09/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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100-130 people
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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
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Sources of funding
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Post graduate funding from Australian Centre for Complementary Medicine, Education and Research (ACCMER) and the School of Natural and Complementary Medicine
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Trial website
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Publications
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Contact name
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Prof
Stephen
Myers
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Address
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P.O. Box 157
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City/town
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Lismore
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Zip/Postcode
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2480
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Country
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Australia
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Tel
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+61 (0)2 66 20 3403
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Fax
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+61 (0)2 66 20 3307
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Email
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smyers@scu.edu.au
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Sponsor
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Australian Centre for Complementary Medicine, Education and Research (ACCMER)
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Address
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P.O. Box 157
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City/town
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Lismore
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Zip/Postcode
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2480
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Country
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Australia
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Email
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joconnor@scu.edu.au
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Date applied
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09/06/2005
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Last edited
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16/11/2006
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Date ISRCTN assigned
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21/09/2005
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