Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 73 for:    aromatherapy

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 : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Huan Ding, Nanjing University of Traditional Chinese Medicine

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.

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

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Acupoint Massage and Aromatherapy Intervention in Elderly People With Mild Cognitive Impairment in Nursing Institutions: A Randomised Controlled Trial
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 30, 2019

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Montreal Cognitive Assessment [ Time Frame: Change from baseline in Montreal Cognitive Assessment at month 3 and month 6. To investigate the cognitive executive function. ]
    An assessment tool for rapid screening for mild cognitive impairment, which assesses many different areas, including: attention and concentration, executive function, memory, language, visual structural skills, abstract thinking, calculation and orientation. force.The total score is 0~30.The higher the score, the better the cognitive state.<26 points indicates cognitive problems.(If the period of education is less than 12 years, add one point.)

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Functional Activities Questionnaire [ Time Frame: Change from baseline in Functional Activities Questionnaire at month 3 and month 6. To investigate the Functional Activities status. ]
    Some surveys can well distinguish between normal cognitive populations and MCl populations, suggesting that complex daily functional assessments can help identify and diagnose MCI patients.The total score is 0~20,The higher the score, the worse the social status



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

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


Locations
Layout table for location information
China, Jiangsu
Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China, 210046
Sponsors and Collaborators
Huan Ding
Investigators
Layout table for investigator information
Principal Investigator: Huan Ding School of Nursing, Nanjing University of Traditional Chinese Medicine

Layout table for additonal information
Responsible Party: Huan Ding, School of Nursing, Nanjing University of Traditional Chinese Medicine, Nanjing University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03857269     History of Changes
Other Study ID Numbers: KY2019002
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Huan Ding, Nanjing University of Traditional Chinese Medicine:
acupressure
Aromatherapy
Nursing Homes
china

Additional relevant MeSH terms:
Layout table for MeSH terms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders