Acupoint Massage and Aromatherapy Intervention in Elderly People With Mild Cognitive Impairment in Nursing Institutions

NCT ID: NCT03857269

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-27

Study Completion Date

2019-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Acupoint Massage

Intervention Type OTHER

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.

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)

Group Type EXPERIMENTAL

lavender essential oil

Intervention Type OTHER

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.

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)

Group Type EXPERIMENTAL

Acupoint Massage and lavender essential oil

Intervention Type OTHER

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.

Blank control group

The group selects elderly people with MCI who do not receive intervention after informed.Participate in routine activities of Nursing homes.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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AM EO AM&EO

Eligibility Criteria

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Inclusion Criteria

1. Chinese people aged 60 years or above;
2. the MOCA screening score \<26, which was corrected based on educational level (Education time \<12, plus one point)
3. ability to perform self-care functions on their own;
4. no confirmed diagnosis of dementia, depression or other psychiatric illnesses which would interfere with cognitive performance;
5. capacity to provide informed consent.

Exclusion Criteria

1. had a medical history of chronic alcoholism or brain trauma occurred in previous years that could interfere with cognition;
2. had been regular users of medications that could affect cognition;
3. had clinical conditions that contraindicated light to moderate physical exercise;
4. any disabilities preventing participation in the MET or KY conditions (e.g. severe visual or hearing impairment);
5. people with olfactory dysfunction or those who are allergic to lavender;
6. skin is broken, can not be massaged;
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huan Ding

OTHER

Sponsor Role lead

Responsible Party

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Huan Ding

School of Nursing, Nanjing University of Traditional Chinese Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Huan Ding

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, Nanjing University of Traditional Chinese Medicine

Locations

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Nanjing University of Chinese Medicine

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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KY2019002

Identifier Type: -

Identifier Source: org_study_id

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