NCT07373132尚未招募不适用
Effects of Aromatherapy on Sleep Quality in Hospitalized Elderly Female Patients With Insomnia: Protocol for A Randomized, Double-Blind, Placebo-Controlled Parallel Trial
The Second Hospital of Anhui Medical University0 个研究点目标入组 64 人开始时间: 2026年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 主要终点
- Athens Insomnia Scale
研究概览
简要总结
To evaluate the efficacy and safety of standardized aromatherapy compared with placebo in improving sleep quality among hospitalized elderly female patients with insomnia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, aged ≥60 years.
- •Hospitalized in the Second Affiliated Hospital of Anhui Medical University.
- •Athens Insomnia Scale (AIS) >
- •Ability to communicate and understand instructions.
- •Non-allergic to essential oils.
- •Fully informed and voluntarily consent to participate.
排除标准
- •Cognitive impairment-.
- •History of hypersensitivity to aromatherapy oils.
- •Use of sedative-hypnotic medications within past 2 weeks.
- •Sleep disorders secondary to organic or psychiatric diseases.
- •Unable to comply with study procedures.
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: Placebo (Other)
aromatherapy
Experimental
干预措施: Aromatherapy (Other)
结局指标
主要结局
Athens Insomnia Scale
时间窗: Evaluated at baseline, day 6 and 2-week follow-up.
Total score 0-24; higher scores indicate worse insomnia.
次要结局
未报告次要终点
研究者
Zengzeng Wei
Clinical Professor
The Second Hospital of Anhui Medical University
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