- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07431164
Augmented Reality-Based Aromatherapy Education for Older Adults With Early-Stage Dementia in Taiwan
The Impact of Augmented Reality-Based Aromatherapy Education on Symptoms in Older Adults With Early-Stage Dementia in Taiwan
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taipei City
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Taipei, Taipei City, Taiwan, 10610
- National Taiwan Normal University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 65 years
- AD-8 score ≥ 2, indicating suspected cognitive impairment
- Ability to communicate and complete study questionnaires
- No significant visual, hearing, or olfactory impairments
- Willingness to participate in AR-based intervention sessions
Exclusion Criteria:
- Diagnosed psychiatric disorder
- Complex chronic physical diseases
- Moderate to severe dementia
- Neuropsychiatric Inventory Questionnaire (NPI-Q) symptom score > 3
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AR-Based Aromatherapy Education Group
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.
|
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.
|
|
No Intervention: Standard Care Control Group
Participants receive routine care without AR-based aromatherapy intervention during the study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Neuropsychiatric Symptoms Measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time Frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
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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.
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Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain (Abbey Pain Scale)
Time Frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
|
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.
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Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
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Insomnia (Athens Insomnia Scale)
Time Frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
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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.
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Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
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Well-Being (WHO-5)
Time Frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
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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.
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Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
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Life Satisfaction (SWLS)
Time Frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
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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.
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Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)
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Collaborators and Investigators
Investigators
- Study Chair: Jong-Long Guo, PhD, National Taiwan Normal University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Neurocognitive Disorders
- Cognition Disorders
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Patient Compliance
- Patient Acceptance of Health Care
- Adherence Interventions
- Medication Adherence
- Cognitive Dysfunction
- Dementia
- Health Education
Other Study ID Numbers
- NTNU-AR-Aroma-2025
- NSTC 112-2410-H-003-061-MY2 (Other Grant/Funding Number: National Science and Technology Council, Taiwan)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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