Acupoint Massage and Aromatherapy Intervention in Elderly People With Mild Cognitive Impairment in Nursing Institutions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03857269|
Recruitment Status : Active, not recruiting
First Posted : February 27, 2019
Last Update Posted : August 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Other: Acupoint Massage Other: lavender essential oil Other: Acupoint Massage and lavender essential oil||Not Applicable|
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.
Where to conduct the study? The investigators anticipate recruiting a total of 120 participants from nursing homes from multiple areas in NanJing,china.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Acupoint Massage and Aromatherapy Intervention in Elderly People With Mild Cognitive Impairment in Nursing Institutions: A Multicenter Clinical Trial|
|Actual Study Start Date :||December 27, 2018|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||October 30, 2019|
Experimental: 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）
Other: Acupoint Massage
The operators is trained for two weeks. At 9 o'clock in the morning, the elderly are organized by Nursing home to perform acupressure.Intervention frequency will be monday to saturday per week for 6 months.
Other Name: AM
Experimental: 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）
Other: lavender essential oil
Modulated by an international aroma therapist,The cotton ball containing essential oil is replaced by the operator at 9 am.Intervention frequency will be monday to saturday per week for 6 months.
Other Name: EO
Experimental: 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）
Other: Acupoint Massage and lavender essential oil
At the same time as the acupressure, patients began to smell the essential oil.Intervention frequency will be monday to saturday per week for 6 months.
Other Name: AM&EO
No Intervention: Blank control group
The group selects elderly people with MCI who do not receive intervention after informed.Participate in routine activities of Nursing homes.
- Mini-mental State Examination [ Time Frame: 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 [ Time Frame: 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.
- Geriatric depression scale [ Time Frame: Change from baseline in Geriatric depression scale at month 3 and month 6. To investigate the Functional Activities status. ]Dedicated to screening for depression in the elderly. The most suitable feelings for the elderly in the past week were evaluated. The scale has a total of thirty entries, including the following symptoms: low mood, reduced activity, irritability, retreat from painful thoughts, negative scores on past, present and future.The total score is 0-10 points, which is normal; 11-20 points, mild depression; 21-30 minutes, moderate to severe depression.
- Pittsburgh sleep quality index [ Time Frame: Change from baseline in Pittsburgh sleep quality index at month 3 and month 6. To investigate the Functional Activities status. ]PSQI was used to assess the quality of sleep in the last month of the test. It consists of 19 self-evaluations and 5 other evaluation items. The 19th self-evaluation item and 5 other evaluation items do not participate in the scoring. Only 18 self-evaluation items participating in the scoring are introduced here. 18 items are composed of 7 components, each component is scored according to o~3 level, and the accumulated components are scored as PSQI total score, and the total score range is 0~2l. The higher the score, the worse the sleep quality. It takes 5 to 10 minutes for the subject to complete the test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03857269
|Nanjing University of Chinese Medicine|
|Nanjing, Jiangsu, China, 210046|
|Principal Investigator:||Huan Ding||School of Nursing, Nanjing University of Traditional Chinese Medicine|