Condition category
Mental and Behavioural Disorders
Date applied
09/06/2005
Date assigned
21/09/2005
Last edited
16/11/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Myers

ORCID ID

Contact details

P.O. Box 157
Lismore
2480
Australia
+61 (0)2 66 20 3403
smyers@scu.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ECN-04-201

Study information

Scientific title

Acronym

Aromatherapy trial

Study hypothesis

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

Not provided at registration time

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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 names

Cypress (Cupressus sempervirens), Lime (Citrus latifolia) and Eucalyptus (Eucalyptus globulus)

Primary outcome measures

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 trial start date

01/04/2005

Overall trial end date

30/09/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

100-130 people

Participant 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

Recruitment start date

01/04/2005

Recruitment end date

30/09/2005

Locations

Countries of recruitment

Australia

Trial participating centre

P.O. Box 157
Lismore
2480
Australia

Sponsor information

Organisation

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

Sponsor details

P.O. Box 157
Lismore
2480
Australia
joconnor@scu.edu.au

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Post graduate funding from Australian Centre for Complementary Medicine, Education and Research (ACCMER) and the School of Natural and Complementary Medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes