Investigating cognitive effects of aromatherapy on people with dementia living in residential care facilities
| ISRCTN | ISRCTN86563511 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86563511 |
| Secondary identifying numbers | ECN-04-201 |
- 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
Scientific
P.O. Box 157
Lismore
2480
Australia
| Phone | +61 (0)2 66 20 3403 |
|---|---|
| smyers@scu.edu.au |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cypress (Cupressus sempervirens), Lime (Citrus latifolia) and Eucalyptus (Eucalyptus globulus) |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/04/2005 |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 100-130 people |
| 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
2480
Australia
Sponsor information
Australian Centre for Complementary Medicine, Education and Research (ACCMER)
Research organisation
Research organisation
P.O. Box 157
Lismore
2480
Australia
| joconnor@scu.edu.au |
Funders
Funder type
Research organisation
Post graduate funding from Australian Centre for Complementary Medicine, Education and Research (ACCMER) and the School of Natural and Complementary Medicine
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
