Acupoint Massage and Aromatherapy Intervention in Elderly People With Mild Cognitive Impairment in Nursing Institutions: A Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mini-mental State Examination
研究概览
简要总结
This study aims to investigate and compare the intervention effects of acupressure,aromatherapy,combining acupressure and aromatherapy in elderly with mild cognitive impairment. The investigators hypothesize that (1) Combined intervention can induce greater improvements in the outcome measures than single mode of intervention; (2) the improvement in cognitive functions and other outcomes may differ between the groups.
详细描述
Background and study aims:
Mild cognitive impairment (MCI) or minor neurocognitive disorder is a syndrome defined as an intermediate stage between cognitively intact and clinically diagnosed dementia. The progression rate from MCI to dementia ranges from 10 to 15% each year, and over 50% of the MCI population will develop into severe cognitive impairment or dementia in 5 years.MCI involves functional decline that may include decrements in engagement in meaningful activities and one's own sense of confidence/mastery, and it is associated with depressive symptoms, poor satisfaction with family communication, and declining physical function. Therefore, early detection of the individuals who manifest MCI and provide appropriate interventions may help reduce the burden of their caregivers and the medical expenses of the health-care system. Previous studies found that acupressure or aromatherapy has emerged as an important therapeutic approach for individuals with MCI. However, the intervention effects of combining acupressure or aromatherapy remain to be determined. Furthermore, whether acupressure and aromatherapy should be administered simultaneously is an important question to pursue. The overall goal of this study is to determine and compare the intervention effects acupressure,aromatherapy, and combining acupressure and aromatherapy in individuals with MCI.
Who can participate? Individuals with MCI (≥60).
What does the study involve? The participants will receive acupressure, aromatherapy, combining acupressure and aromatherapy randomly. Intervention frequency will be 5-6 times per week for 6 months. All participants will received pretreatment test, post treatment test, and a 1-month follow-up test.
What are the possible benefits and risks of participating? The possible benefits include improvement in cognitive, and daily functions. There are no risks for participating.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese people aged 60 years or above;
- •the MOCA screening score <26, which was corrected based on educational level (Education time <12, plus one point)
- •ability to perform self-care functions on their own;
- •no confirmed diagnosis of dementia, depression or other psychiatric illnesses which would interfere with cognitive performance;
- •capacity to provide informed consent.
排除标准
- •had a medical history of chronic alcoholism or brain trauma occurred in previous years that could interfere with cognition;
- •had been regular users of medications that could affect cognition;
- •had clinical conditions that contraindicated light to moderate physical exercise；
- •any disabilities preventing participation in the MET or KY conditions (e.g. severe visual or hearing impairment);
- •people with olfactory dysfunction or those who are allergic to lavender；
- •skin is broken, can not be massaged；
研究组 & 干预措施
Acupoint Massage group
Choose Chinese medicine acupuncture points： Shenting, Baihui, Sishencong, Diwei, Chengling, Fengchi, Fengfu，Zusanli and Sanyinjiao，32 points per acupressure.32 times per acupoint.Intervention frequency will be monday to saturday per week for 6 months.（n=30）
干预措施: Acupoint Massage (Other)
Aromatherapy group
Make a 5x5cm bag and put a cotton ball in the bag and the bag is clipped to the patient's collar.Dispense 10% lavender essential oil, 2-3 drops a day in cotton balls.Cotton ball replacement daily. Intervention frequency will be monday to saturday per week for 6 months.（n=30）
干预措施: lavender essential oil (Other)
Acupoint Massage and Aromatherapy group
At the same time as the acupressure, the essential oil is applied to the collar and begins to sniff.Intervention frequency will be monday to saturday per week for 6 months.（n=30）
干预措施: Acupoint Massage and lavender essential oil (Other)
Blank control group
The group selects elderly people with MCI who do not receive intervention after informed.Participate in routine activities of Nursing homes.
结局指标
主要结局
Mini-mental State Examination
时间窗: Change from baseline in Mini-mental State Examination at month 3 and month 6. To investigate the Intelligence state.
The table is simple and easy to use, widely used at home and abroad, and is the preferred scale for dementia screening. The scale includes the following seven aspects: time-orientation, location-orientation, immediate memory, attention and computational power, delayed memory, language, and visual space.The total score of the scale ranges from 0-30 points. The test scores are closely related to the cultural level. The normal boundary value is:uneducated people（\>17）.primary school education（\>20）, and middle high school or above（\>24）, indicating good mental state. The higher the total score, the better the situation.
Wechsler Intelligence Scale
时间窗: Change from baseline in Wechsler Intelligence Scale at month 3 and month 6. To investigate the Memory capacity.
There are ten aspects of the scale. Consult relevant experts and consult literature, this program selects four aspects: logical memory(0\~25), association learning(0\~21), picture recall(0\~20), and number of memories(0\~17).Add the total scores, the higher the score, the better the memory.
次要结局
- Geriatric depression scale(Change from baseline in Geriatric depression scale at month 3 and month 6. To investigate the Functional Activities status.)
- Pittsburgh sleep quality index(Change from baseline in Pittsburgh sleep quality index at month 3 and month 6. To investigate the Functional Activities status.)
研究者
Huan Ding
School of Nursing, Nanjing University of Traditional Chinese Medicine
Nanjing University of Traditional Chinese Medicine