Clinical trial NCT03576170: Investigate the Efficacy and Effectiveness of Aromatherapy for the Management of Behavioral and Psychological Symptoms of Dementia
Official title: Investigate the Efficacy and Effectiveness of Aromatherapy for the Management of Behavioral and Psychological Symptoms of Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 112
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: In recent decades, following an increased longevity in Hong Kong, there is a drastic increase in the prevalence chronic conditions, including dementia. Behavioral and psychological symptoms of dementia (BDSP) seem to be the main reasons of suffering for many older adults. This condition does not only pose a burden to the whole family but also the healthcare system.

While conventional treatment of BPSD using pharmacotherapy and non-pharmacological treatments has been effective for managing symptoms, owing to the adverse side effects caused by anti-psychotic drugs and the short effective period incurred by non-pharmacological interventions, development of alternative and non-pharmacological approaches for the management of behavioral disturbances and pain is of urgent need. Research has shown that aromatherapy (both administered through inhalation and therapeutic massage) has been effective in reducing behavioral disturbances of dementia patients. These findings support the premise that aromatherapy and the investigators hope to provide further evidence to support the use of aromatherapy as an evidence-based mainstream intervention for reducing behavioral and psychological symptoms of dementia (BPSD).

Whilst there is sufficient evidence to support the effectiveness of aromatherapy, few studies compared the effectiveness of the use of aromatherapy by inhalation and/or therapeutic massage. The investigators aim to address the above research gaps on the clinical application of aromatherapy on BPSD, with a focus on comparing the differential effectiveness between administration by inhalation and administration by therapeutic massage. The proposed research aims to (1) test the efficacy and effectiveness of aromatherapy on the symptom management of BPSD in older adults; (2) compare the effects of aromatherapy-scent (i.e., inhalation) and aromatherapy-touch (i.e., therapeutic massage) in older adults with BPSD. This study also explores the benefits of aromatherapy on cognitive functioning, functional performance and social engagement as secondary outcomes.

A randomized, controlled, and single blinded trial is proposed. 120 older adults with BPSD will be randomly assigned to aroma inhalation (intervention), aroma-touch or wait-list (control) treatments. The primary outcomes measured are a caregiver-rated inventory of agitated behaviors and abnormalities of mood and psychotic phenomenal, cognitive functioning, functional performance and social engagement (secondary outcome) will be assessed three time points the study hypotheses are supported, the findings will provide empirical support for a treatment option that could improve psychological well-being and also improve cognitive functioning, functional performance, and social engagement of older adults.


Eligibility criteria: Inclusion Criteria:

* 60 years of age or older
* have a CMMSE score below 18 if illiterate, 19 if they have 1-2 years of education, and 20 if they had more than 2 years of education
* reported to have BPSD;
* willing to participate in the research, with informed consent signed by their guardian or carer.

Exclusion Criteria:

* allergic to essential oils
* refused to give consent
* over-sensitive to tactile stimulation
* have a history of kidney and liver disease
* have ever had an epileptic seizure.

Primary outcomes:
measure: Chinese Version of the Cohen- Mansfield Agitation Inventory (CMAI)
timeFrame: baseline, 2-months after intervention and after the completion of the intervention in four months
measure: Chinese Version of the Neuropsychiatric Inventory (NPI)
timeFrame: baseline, 2-months after intervention and after the completion of the intervention in four months
Secondary outcomes:
measure: Cantonese Version of the Mini-mental State Examination (CMMSE)
timeFrame: baseline, 2-months after intervention and after the completion of the intervention in four months
measure: Chinese Version of the Barthel Index-100
timeFrame: baseline, 2-months after intervention and after the completion of the intervention in four months
measure: Chinese Version of the Index of Social Engagement(ISE)
timeFrame: baseline, 2-months after intervention and after the completion of the intervention in four months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechinic University
Study officials:
References: