None listed
Conditions
Brief summary
The behavioural and psychological symptoms of dementia (BPSD) are a constellation of distressing non-cognitive symptoms that frequently accompany dementia, affecting up to 82% of nursing home residents with the disorder. Agitation is a commonly reported BPSD, as are aggression, delusions, anxiety and depression. These symptoms can be distressing to the person with dementia and their carer, and can significantly increase the burden of care. BPSD has also been shown to increase the total annual cost of dementia care in the community by more than 30%, with 2002 estimates indicating an increase in both direct and indirect care costs of dementia care by 25% and 35%, respectively. Antipsychotic medication continues to be the primary mode of treatment for BPSD; this is despite reservations about the clinical effectiveness and safety of these agents for BPSD. A 7-tiered BPSD management model was proposed in 2003 in an attempt to improve the management of BSPD, and to reduce antipsychotic use. In the lower tiers of the model, non-pharmacological treatment is recommended as first-line management, with antipsychotics only indicated as a `last resort' if symptoms cause severe distress or an immediate risk of harm to the patient or others. In light of these recommendations, as well as concerns regarding the cost, safety and effectiveness of antipsychotic medication for the management of BPSD, many carers and health providers are turning to the use of non-pharmacological therapies to manage agitation and other BPSD. One such approach that is receiving increasing attention in the literature because of its purported safety, low-cost, high level of acceptance and ease of implementation, is aromatherapy. Aromatherapy is the therapeutic administration of plant essential oils via inhalation or topical application. Empirical evidence suggests that essential oils may assist in the management of agitation and BPSD by acting on the neurolimbic system, and by upregulating neurotransmitter synthesis to generate antidepressant, anxiolytic and sedative effects. Despite essential oils being a biologically plausible, low-cost and well-tolerated treatment for BPSD, current evidence of effectiveness is conflicting, with some calling for higher-quality, longer-term trials. In response to these recommendations, researchers at the University of South Australia Department of Rural Health will be conducting a cluster-randomised, placebo-controlled feasibility trial to explore whether topically-administered, individualised essential oil preparations are effective in alleviating agitation in persons with dementia. The 10-week trial will be implemented across two residential aged care facilities in regional South Australia, and is hoping to recruit at least 30 residents with dementia. Findings from this trial will determine the feasibility of conducting a large effectiveness trial of essential oils for agitation in dementia.
Interventions
INTERVENTION: Participants in the intervention group will receive a bespoke blend of essential oils (4.5%) in a cream base, and a bespoke blend of essential oils (3%) in an oil base, at a dose of 20mls three times daily (for the cream), and 10 mls three times daily, as required (for the oil), for 8 consecutive weeks; the intervention will be administered topically (i.e. forearms/face/neck/shoulders for the cream [depending on participant preference], and lower legs for the oil) by trained nursin
INTERVENTION: Participants in the intervention group will receive a bespoke blend of essential oils (4.5%) in a cream base, and a bespoke blend of essential oils (3%) in an oil base, at a dose of 20mls three times daily (for the cream), and 10 mls three times daily, as required (for the oil), for 8 consecutive weeks; the intervention will be administered topically (i.e. forearms/face/neck/shoulders for the cream [depending on participant preference], and lower legs for the oil) by trained nursing staff. Each blend will be personalised based on the participant’s odour preference, unique presentation of symptoms, and health history (including known sensitivities and contraindications to any oils or their chemical constituents). The interventions will be blended by a trained aromatherapist, who will select up to five appropriate essential oils from a list of 38 hypoallergenic oils. Fidelity will be assessed using a medication record, and by noting the remaining volume of cream in the intervention receptacle at weeks 4 (mid-intervention) and 8 (post-intervention).
Sponsors
University of South Australia Department of Rural Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) Has been a resident of the study site for a period of at least 4 weeks. (2) Has a diagnosis of dementia (as determined by Mini-Mental State Examination (MMSE), DSM-IV criteria or medical diagnosis). (3) Has clinically significant agitation (as defined by a score of 39 or greater on the CMAI, or a score of 4 or greater on the Pittsburgh Agitation Scale [PAS]) (4) Can provide informed consent, both directly (if appropriate) and via their next of kin.
Exclusion criteria
(1) Concurrent exposure to essential oils in any form (2) Concurrent exposure to other novel therapeutic interventions for agitation (e.g. Paro, Play up) (3) History of significant head trauma or brain lesions (4) Known allergy or sensitivity to any of the ingredients in the active or control interventions.
Outcome results
None listed