跳至主要内容
临床试验/NCT03108781
NCT03108781Unknown不适用

The Role of Aromatherapy With Lavender Oil in the Long-term Care on a Patients Behavioral Problems Associated With Dementia

Soroka University Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Behavioral symptoms

研究概览

简要总结

Testing of Lavender Oil aromatherapy effect on behavior disorders in patients with severe dementia who are hospitalized in the ward for the mentally frail.

详细描述

Dementia as one of the most debilitating diseases presents with decline in memory and cognitive functions causing reduction in the intellectual abilities and every day functions. Today, there are estimated 24 million people suffering from dementia world wide and those numbers are expected to double every 20 years (Qiu, De Ronchi, & Fratiglioni, 2007).

About 80% of all patients suffering from dementia will develop at some point behavioural and psychological symptoms (BPSD)(Aalten et al., 2003). These symptoms will develop in at least 50% of patients treated in outpatient setting and in 75% of patients in nursing homes (Zaudig, 2000).

The behavioural and psychological symptoms (BPSD) syndrome may lead to high degree of distress in the patient and close-once, causing burnout of the primary care giver and transfer of the patient to a nursing home.

These days, the primary treatment is based on antipsychotic pharmacotherapy that is often associated with side affects and far from assured efficiency and safety (Fung, Tsang, & Chung, 2012). Research showed that the usage of antipsychotic drugs increases the chance of stroke and premature death and thus, the food and drugs administration (FDA) recommends to avoid the usage of these drugs in treatment of dementia (Ballard et al., 2009).

Non-pharmacological approach represents a good alternative in treatment of behavioural and psychological symptoms (BPSD). During the last decade the usage of alternative medicine is increasing (Fung et al., 2012), including the usage of aromatherapy in order to reduce anxiety and restlessness in dementia patients (Hersh & Falzgraf, 2007).

研究设计

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

入排标准

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

入选标准

  • Patients hospitalised in the mental frail wards of the "Mental Health Centre, Beer-Sheva".
  • Patients diagnosed with dementia (of all kinds).
  • Patients with informed consents from their guardians

排除标准

  • Patients without informed consent.
  • Patients with hypersensitivity to Lavender Oil

研究组 & 干预措施

Lavender Oil

Active Comparator

干预措施: Lavender Oil (Drug)

Lavender Oil

Active Comparator

干预措施: sunflower oil (Drug)

sunflower oil

Placebo Comparator

干预措施: Lavender Oil (Drug)

sunflower oil

Placebo Comparator

干预措施: sunflower oil (Drug)

结局指标

主要结局

Behavioral symptoms

时间窗: 4 mounths

Behavioral symptoms will be measured by Neuropsychiatric Inventory scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yan Press

Head of gariatric department

Soroka University Medical Center

研究点 (1)

Loading locations...

相似试验

The Role of Aromatherapy With Lavender Oil in the... | 临床试验