To determine if diffusion aromatherapy exposure to an essential oil blend can potentially improve mild cognitive impairment/mild dementia symptoms and relieve caregiver stress. This study also allows us to gauge the willingness of elderly patients in complying with long-term aromatherapy treatments.
SENSE is a non-blinded study that aims to recruit 200 participants, consisting of 200 patients with MCI or mild dementia, along with their respective caregivers. Participants will be recruited from the Geriatric Clinic in Sengkang General Hospital, in either English or Chinese. Participants are randomized into the control and intervention group, in which the latter will receive an aromatherapy diffuser, a proprietary aromatic asian plant extract (AAPE) as an essential oil blend to add into the diffuser, and an aromatherapy diary to fill up for 6 months. The participants of the intervention group are to diffuse the essential oils twice daily for a minimum of 5 minutes each session, and will also receive phone calls at the 2, 4, 6, 8, 16, and 20th week timepoint to check on compliance and adverse events. Both the control and intervention group will complete questionnaires on the first visit, mid-intervention visit (12th week timepoint) and final visit (24th week timepoint): Patients: * Patient Baseline Data Collection Form (only for first visit) * Mini-mental state examination (MMSE) * Cornell Scale for Depression in Dementia (CSDD) * Rating Anxiety in Dementia (RAID) * Sniffin' Sticks Olfactory Test (only for first and final visit) Caregivers: * Caregiver Baseline Data Collection Form (CBDCF) * Neuropsychiatric Inventory Questionnaire (NPI-Q) * ZBI-12 (Zarit Caregiver Burden Assessment) All three visits are physical visits at Sengkang General Hospital. Upon completion of each physical visit's requirements, participants will receive a $10 reimbursement voucher.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
200
Participants randomised to the control group will only complete the behavioural and caregiver assessments.
Besides being given assessments mentioned in the control group, participants randomised to the intervention group will be provided with a diffuser, the first batch of the AAPE oil blend (patient to choose 1 out of the 2 blends), and detailed instructions on aromatherapy use. They will be instructed to diffuse 1-2 drops of the oil for 30 minutes in the morning and before bedtime (minimally 5 minutes), inhaling and relaxing during these sessions. An Aromatherapy Diary will be provided to track daily compliance, record adverse events, and document the number of minutes used each night.
National Cancer Centre Singapore
Singapore, Singapore
Sengkang General Hospital
Singapore, Singapore
Feasibility and acceptability of an olfactory enrichment program in improving the well-being of patients with mild cognitive impairment (MCI) and dementia.
To gauge the compliance and willingness to comply with long-term aromatherapy treatments in their homes, in a local context. Compliance rate will be calculated using the total number of sessions that the participants have fulfilled, for at least 5 minutes each session. Patients that are unable to meet the minimum of 50% compliance will be withdrawn from the study.
Time frame: Mid-intervention (12 weeks), and post intervention (24 weeks).
Preliminary efficacy of the intervention in reducing Behavioural and Psychological Symptoms of Dementia (BPSD) to inform sample size calculations for a larger study through the use of Rating Anxiety in Dementia (RAID) Questionnaire.
RAID utilizes a scale that includes "unable to evaluate" and 0-3. Questionnaires are analysed by tabulating the total scores of each questionnaire to assess the severity of anxiety.
Time frame: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
Preliminary efficacy of the intervention in reducing Behavioural and Psychological Symptoms of Dementia (BPSD) to inform sample size calculations for a larger study through the use of Cornell Scale for Depression in Dementia (CSDD) Questionnaire.
CSDD utilizes a scale that includes "absent" and 0-2. Questionnaires are analysed by tabulating the total scores of each questionnaire to assess the severity of depressive symptoms.
Time frame: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
Preliminary efficacy of the intervention in maintaining cognitive function in patients with MCI and dementia.
This is measured using Mini-mental state examination (MMSE), which measures cognitive function on a 30-point scale. A higher score indicates better cognitive function.
Time frame: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
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Impact of the intervention on caregiver stress and burden via Neuropsychiatric Inventory Questionnaire (NPI-Q)
For the caregivers to fill, to see if the impact of diffusion aromatherapy on the respective patients can improve behavioural symptoms observed in the patient. The NPI-Q requires rating presence of a symptom (a "yes" or "no" screening question), the severity on a 1-3 point scale, and caregiver's distress from the symptom on a 0-5 point scale. The total scores of these questionnaires help to assess the severity of caregiver stress and burden, with a higher total score suggesting overall a greater presence of neuropsychiatric symptoms.
Time frame: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).
Impact of the intervention on caregiver stress and burden via ZBI-12 (Zarit Caregiver Burden Assessment)
For the caregivers to fill, to see if the impact of diffusion aromatherapy on the respective patients can potentially relieve some caregiver stress and burden. The ZBI-12 is completed by the caregivers and utilises a 0-4 point scoring system for 12 questions totaling a score from 0 to 48, where higher scores indicate greater caregiver burden.
Time frame: Baseline (first visit), mid-intervention (12 weeks), and post intervention (24 weeks).