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临床试验/NCT07431164
NCT07431164进行中(未招募)不适用

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

National Taiwan Normal University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年5月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
300
试验地点
1
主要终点
Change in Neuropsychiatric Symptoms Measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q)

研究概览

简要总结

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.

详细描述

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):

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Diagnosed psychiatric disorder
  • Complex chronic physical diseases
  • Moderate to severe dementia
  • Neuropsychiatric Inventory Questionnaire (NPI-Q) symptom score > 3

研究组 & 干预措施

AR-Based Aromatherapy Education Group

Experimental

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.

干预措施: Augmented Reality-Based Aromatherapy Education Program (Behavioral)

Standard Care Control Group

No Intervention

Participants receive routine care without AR-based aromatherapy intervention during the study period.

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Pain (Abbey Pain Scale)(Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up))
  • Insomnia (Athens Insomnia Scale)(Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up))
  • Well-Being (WHO-5)(Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up))
  • Life Satisfaction (SWLS)(Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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