An interventional study of Augmented Reality-Based Aromatherapy Education Program in Dementia, Mild Cognitive Impairment (MCI) and Neuropsychiatric Symptoms, sponsored by National Taiwan Normal University. Active, not recruiting at 1 site in Taiwan. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by National Taiwan Normal University · Not applicable, Interventional, and Treatment
This study evaluates an augmented reality (AR)-based aromatherapy education program designed for older adults with early-stage dementia in Taiwan. Participants are randomly assigned to either the intervention group, which receives AR-supported aromatherapy education sessions, or a comparison group receiving standard activities. The primary objective is to assess changes in neuropsychiatric symptoms and psychological well-being. Secondary outcomes include cognitive function and quality of life. The study aims to explore the feasibility and potential clinical benefits of integrating digital technology with non-pharmacological dementia care approaches.
The study includes multiple phases designed to examine both immediate and longer-term effects of the intervention.
Phase 1 - Structured AR-Based Aromatherapy Education (Weeks 1-4):
Participants receive the AR-based aromatherapy education program consisting of 12 structured sessions delivered over four weeks. Sessions integrate AR-guided instruction with hands-on aromatherapy learning activities.
The Augmented Reality (AR)-Based Aromatherapy Education Module was systematically developed according to the 12 symptom domains of the Neuropsychiatric Inventory Questionnaire (NPI-Q). Each unit was designed to align a specific neuropsychiatric symptom with targeted plant-based aromatic stimulation, structured educational activities, and symptom-oriented behavioral goals. The intervention consisted of 12 structured units delivered over four to six consecutive weeks (two to three sessions per week). Each session integrated AR-based digital guidance with hands-on aromatherapy activities to provide multisensory stimulation, cognitive engagement, and structured emotional regulation support.
Phase 2 - Aromatherapy Withdrawal Observation (Weeks 5-8):
Following completion of the structured sessions, aromatherapy products are discontinued to observe potential maintenance or withdrawal effects of the intervention. Participants continue routine daily activities without additional aromatherapy sessions.
Phase 3 - Personalized Aromatherapy Support (Weeks 9-12):
Based on symptom profiles and individual preferences, participants may receive guidance on the use of personalized aromatherapy products intended to support symptom management in daily life.
Phase 4 - Follow-Up Observation (Weeks 13-16):
Participants are followed to evaluate the sustainability of intervention effects. Outcome assessments are conducted to examine longer-term changes in neuropsychiatric symptoms and related health outcomes.
The comparison group receives routine care and standard daily activities at the care setting without participation in the AR-based aromatherapy education program.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 300 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →National Taiwan Normal University is the lead sponsor of 62 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Participants receive a structured augmented reality (AR)-based aromatherapy education program designed to reduce neuropsychiatric symptoms and enhance psychological well-being in older adults with early-stage dementia. The intervention includes guided AR modules integrating sensory stimulation, aromatherapy education, and interactive cognitive engagement over the study period.
Behavioral: Augmented Reality-Based Aromatherapy Education Program
Participants receive routine care without AR-based aromatherapy intervention during the study period.
The augmented reality-based aromatherapy education module was developed using the Neuropsychiatric Symptom Checklist-Q (NPI-Q) framework to match specific neuropsychiatric symptoms with corresponding aromatherapy interventions. This intervention program was designed and refined by a multidisciplinary team of experts. The course comprises 12 units, completed over four consecutive weeks through 2-3 units per week. To ensure a systematic approach, each session integrates three units, allowing for comprehensive coverage of symptom clusters within a structured timeframe. Each symptom corresponds to a specific aromatherapy activity and its associated learning objectives.
Change in Neuropsychiatric Symptoms Measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q)
Neuropsychiatric symptoms are assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q), an informant-based instrument evaluating behavioral and psychological symptoms over the past month. Each symptom is rated for severity on a 3-point scale (1 = mild, 2 = moderate, 3 = severe). Total scores range from 0 to 36, with higher scores indicating more severe neuropsychiatric symptoms (worse outcome). Changes in total scores from baseline will be analyzed.
Time frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
Pain (Abbey Pain Scale)
Pain is assessed using the Abbey Pain Scale, an observational tool designed to evaluate pain in individuals who may have difficulty verbally communicating discomfort. The scale consists of six behavioral indicators (vocalization, facial expression, change in body language, behavioral change, physiological change, and physical changes), each rated on a 4-point scale (0 = absent to 3 = severe). The total score ranges from 0 to 18, with higher scores indicating greater pain severity (worse outcome). Changes in total scores from baseline will be analyzed.
Time frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
Insomnia (Athens Insomnia Scale)
Insomnia symptoms are assessed using the Athens Insomnia Scale (AIS), a self-report instrument designed to evaluate sleep difficulties based on the diagnostic criteria of insomnia. The scale consists of eight items assessing sleep induction, awakenings during the night, early morning awakening, total sleep duration, sleep quality, well-being during the day, functioning capacity, and sleepiness during the day. Each item is rated on a 4-point scale (0-3). The total score ranges from 0 to 24, with higher scores indicating more severe insomnia symptoms (worse outcome). Changes in total scores from baseline will be analyzed.
Time frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
Well-Being (WHO-5)
Psychological well-being is assessed using the World Health Organization-Five Well-Being Index (WHO-5), a self-report questionnaire measuring positive mood, vitality, and general interest in daily activities over the previous two weeks. The scale includes five items, each rated on a 6-point scale (0-5). The total score ranges from 0 to 25, with higher scores indicating better psychological well-being (better outcome). Changes in total scores from baseline will be analyzed.
Time frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
Life Satisfaction (SWLS)
Life satisfaction is assessed using the Satisfaction With Life Scale (SWLS), a self-report instrument measuring global cognitive judgments of one's life satisfaction. The scale consists of five items, each rated on a 7-point Likert scale (1-7) ranging from strongly disagree to strongly agree. The total score ranges from 5 to 35, with higher scores indicating greater life satisfaction (better outcome). Changes in total scores from baseline will be analyzed.
Time frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in this trial will be made available upon reasonable request after publication. Access requires a formal request to the corresponding author and approval. Data will be shared in accordance with institutional review board approval and applicable data protection regulations. Researchers requesting access must provide a methodologically sound proposal and sign a data use agreement. Only de-identified data will be shared; no direct identifiers will be released.
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This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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National Taiwan Normal University