Sensory Enrichment Using Aromatherapy for Neurobehavioral and Psychological Symptoms in Early Dementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-99
SponsorNational Cancer Centre, Singapore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 50 years old and above.
Confirmed diagnosis of MCI or mild dementia based on clinical records.
Has one identified caregiver aged 21 years and above who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study intervention.
Aged 21 years old and above.
Disqualifiers
Olfactory impaired/dysfunctional.
Known or suspected hypersensitivity/allergy to essential oils or any components of the formulations.
Has Reactive Airway Disease (e.g, Asthma).
Participant without a caregiver.
Trial design
Design model
Parallel
Treatments tested in this trial
No Intervention
Other interventionParticipants randomised to the control group will only complete the behavioural and caregiver assessments.
Aromatherapy
Other interventionBesides 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Control GroupExperimental treatment 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).2
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).3
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).Secondary outcomes
1
Preliminary efficacy of the intervention in maintaining cognitive function in patients with MCI and dementia.
This is measured using the Montreal Cognitive Assessment (MoCA), 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).2
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).3
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cancer Centre, Singapore
Lead sponsor
Temasek Foundation
Collaborator
Source ClinicalTrials.gov