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

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupoint Massage
lavender essential oil
Acupoint Massage and lavender essential oil
Sponsored by
Huan Ding
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring acupressure, Aromatherapy, Nursing Homes, china

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Nanjing University of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Acupoint Massage group

Aromatherapy group

Acupoint Massage and Aromatherapy group

Blank control group

Arm Description

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)

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)

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)

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

Outcomes

Primary Outcome Measures

Mini-mental State Examination
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
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.

Secondary Outcome Measures

Geriatric depression scale
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
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.

Full Information

First Posted
February 23, 2019
Last Updated
August 23, 2019
Sponsor
Huan Ding
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1. Study Identification

Unique Protocol Identification Number
NCT03857269
Brief Title
Acupoint Massage and Aromatherapy Intervention in Elderly People With Mild Cognitive Impairment in Nursing Institutions
Official Title
Acupoint Massage and Aromatherapy Intervention in Elderly People With Mild Cognitive Impairment in Nursing Institutions: A Multicenter Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 27, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
October 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Huan Ding

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
acupressure, Aromatherapy, Nursing Homes, china

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupoint Massage group
Arm Type
Experimental
Arm Description
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)
Arm Title
Aromatherapy group
Arm Type
Experimental
Arm Description
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)
Arm Title
Acupoint Massage and Aromatherapy group
Arm Type
Experimental
Arm Description
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)
Arm Title
Blank control group
Arm Type
No Intervention
Arm Description
The group selects elderly people with MCI who do not receive intervention after informed.Participate in routine activities of Nursing homes.
Intervention Type
Other
Intervention Name(s)
Acupoint Massage
Other Intervention Name(s)
AM
Intervention Description
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
Intervention Name(s)
lavender essential oil
Other Intervention Name(s)
EO
Intervention Description
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
Intervention Name(s)
Acupoint Massage and lavender essential oil
Other Intervention Name(s)
AM&EO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mini-mental State Examination
Description
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.
Time Frame
Change from baseline in Mini-mental State Examination at month 3 and month 6. To investigate the Intelligence state.
Title
Wechsler Intelligence Scale
Description
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.
Time Frame
Change from baseline in Wechsler Intelligence Scale at month 3 and month 6. To investigate the Memory capacity.
Secondary Outcome Measure Information:
Title
Geriatric depression scale
Description
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.
Time Frame
Change from baseline in Geriatric depression scale at month 3 and month 6. To investigate the Functional Activities status.
Title
Pittsburgh sleep quality index
Description
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.
Time Frame
Change from baseline in Pittsburgh sleep quality index at month 3 and month 6. To investigate the Functional Activities status.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huan Ding
Organizational Affiliation
School of Nursing, Nanjing University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing University of Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210046
Country
China

12. IPD Sharing Statement

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

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