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NCT Number: NCT07431164

Augmented Reality-Based Aromatherapy Education for Older Adults With Early-Stage Dementia in Taiwan

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Dementia Adherence Interventions Behavior Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Health Behavior Health Education Medication Adherence Mental Disorders Mild Cognitive Impairment (MCI) Nervous System Diseases Neurocognitive Disorders Neuropsychiatric Symptoms Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan Normal University

Taipei, Taipei City, 10610, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Augmented Reality-Based Aromatherapy Education Program

Behavioral

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.

Primary outcomes

  1. Change in Neuropsychiatric Symptoms Measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q)

    Time frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)

    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.

Secondary outcomes

  1. 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.

  2. Insomnia (Athens Insomnia Scale)

    Time frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)

    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.

  3. Well-Being (WHO-5)

    Time frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)

    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.

  4. Life Satisfaction (SWLS)

    Time frame: Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)

    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.

Sponsors and collaborators

Lead sponsor

National Taiwan Normal University

Other

Registry information

Official study title

The Impact of Augmented Reality-Based Aromatherapy Education on Symptoms in Older Adults With Early-Stage Dementia in Taiwan

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 24, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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