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

Completed

Conditions: Dementia
Mental and Behavioural Disorders

Registration Number: ISRCTN86563511

Lead Sponsor: Australian Centre for Complementary Medicine, Education and Research (ACCMER)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 130

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.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>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.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures will be:<br>1. Difference in baseline, repeated measures and endpoint scores on the Nurses? Observation Scale for Geriatric Patients (NOSGER) (Spiegel et al. 1991)<br>2. Changes in the use of other medications related to cognitive and behavioural functions (for example, anti-depressants, anti-psychotics)<br>3. Correlation between ability to smell the treatments and end-point scores on MMSE and NOSGER