Determining the Effect of Music Therapy on the Cognitive and Executive Function of the elderly with Mild Cognitive Impairment
Design
The clinical trial has a control group, with a parallel group, double-blind, randomized, without phase on 36 patients. blocked Randomization was used.
Settings and conduct
Study Location: The study will be conducted in daily elderly care centers in Tehran. Two centers will be selected, and permission will be obtained for data collection. The MoCA test will be administered to all attendees of both centers, and based on the results and inclusion criteria, 17 participants from each center will be selected using Blocked randomization. After obtaining written informed consent, pre-tests will be conducted on both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Proficiency in the Persian language
Score between 19 and 22 on the MoCA cognitive test
A minimum of 4 years of education
No speech problems
No hearing problems
Informed consent to participate in the study
Exit criteria
Lack of cooperation and unwillingness to continue the treatment
Acute illness that prevents participation in the intervention
Intervention groups
Intervention Protocol: For the experimental group, music therapy will be conducted twice a week for 8 weeks, totaling 16 sessions of 90 minutes each. The intervention includes vocalization, recognizing and analyzing rhythms, and repeating them to train auditory skills. Participants will practice proverbs with the trained rhythm and actively use musical instruments, clapping, and rhythmic movements.
Control Group: Participants will receive routine services provided by the daily elderly care center
Main outcome variables
Cognitive Functions; Executive Functions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240623062219N1
Registration date:2024-07-25, 1403/05/04
Registration timing:prospective
Last update:2024-07-25, 1403/05/04
Update count:0
Registration date
2024-07-25, 1403/05/04
Registrant information
Name
Negin Ramezani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7173 2000
Email address
vrashedi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-04, 1403/05/14
Expected recruitment end date
2024-10-05, 1403/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Music Therapy on the Cognitive and Executive Function among Older Adults Individuals with Mild Cognitive Impairment
Public title
The Effect of Music Therapy on the Cognitive and Executive Function of the Older Adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Score between 19 and 22 on the MoCA Cognitive Test: Scoring within this range on the MoCA test indicates mild cognitive impairment in the elderly.
Minimum Education of 4 Years: According to the MoCA test guidelines, a minimum of 4 years of education is required to take the test.
No Speech Problems: Participants must not have speech problems since active music therapy involves repeating rhythms with voice and singing.
No Hearing Problems: If participants have hearing issues, they should use a hearing aid. The Whisper Test will be used to assess hearing problems.
Informed Consent: Participants must provide informed consent to participate in the study.
Proficiency in the Persian Language
Exclusion criteria:
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
For the randomization of elderly participants considering the sample size, the method of blocked randomization is used. To this end, by creating blocks of four (ABAB), a total of 36 elderly participants will be randomly assigned to two groups (A: intervention) and (B: control). In this method, due to the use of blocks of four, a maximum of one of the two groups will have up to 2 participants more than the other group. Therefore, the highest level of balance between the numbers in the two groups will be achieved.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding in Pre- and Post-Test Evaluations: The evaluator will not know whether the participant is in the control or intervention group during pre- and post-test assessments.
Data Analyst Blinding: The person analyzing the data will not know which group (control or intervention) the participant belongs to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of University of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar Ave, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2024-05-28, 1403/03/08
Ethics committee reference number
IR.USWR.REC.1403.063
Health conditions studied
1
Description of health condition studied
Mild Cognitive Impairment
ICD-10 code
G31.84
ICD-10 code description
Mild cognitive impairment, so stated
Primary outcomes
1
Description
Cognitive Function
Timepoint
At the beginning of the study (beforehand of the start of the intervention) and 60 days after the Music Therapy
Method of measurement
Montreal Cognitive Assessment
2
Description
Executive Function
Timepoint
At the beginning of the study (beforehand of the start of the intervention) and 60 days after the Music Therapy
Method of measurement
Trial making A&B, Wechsler digit span (forward and backward),Cognitive and Motor (Dual task)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the experimental group, Music Therapy will be conducted twice a week for 8 weeks, totaling 16 sessions of 90 minutes each. Music therapy is done in an active way (the person actively participates in performing the rhythm with his hands and singing) and passively (he only listens to the music). Simple rhythms are taught and musical instruments are used.
Category
Treatment - Other
2
Description
Control group: The recipients of routine services of the day care center for the older adults.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Day care center for the older adults
Full name of responsible person
Mehrdad Baghaei vaji
Street address
No 114, south Dibaji
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 2277 4840
Email
Info@fiftyplusgroup.com
2
Recruitment center
Name of recruitment center
Yas Rehabilitation center
Full name of responsible person
Marziye shirazikhah
Street address
Alstom Power Plant, Satarkhan Ave
City
Tehran
Province
Tehran
Postal code
11111111111
Phone
+98 21 4428 0429
Email
yasrehab95@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. HamidReza Khanke
Street address
Kodakyar Avn, Daneshoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2000
Email
pr@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Payam Noor University East Tehran Branch
Full name of responsible person
Dr. Majid Akhshabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Music Therapy
Street address
No. 5, Shirazi Avn, Sazman Ab Avn, Hakimiyeh
City
Tehran
Province
Tehran
Postal code
1659639884
Phone
+98 21 7731 8581
Email
Majidakhshabi@pnu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Vahid Rashedi
Position
professor Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Koodakyar Avn, Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2000
Email
vahidrashedi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Negin Ramezani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
Koodakyar Avn. Daneshjoo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2000
Email
neginramezaniot40@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Study protocol: The study protocol will be shared in the form of a scientific article.
Clinical Study Report: The results of this study will be shared in the form of a scientific article.
When the data will become available and for how long
Availability Timeline: The protocol and clinical study report will be available after the publication of the study's resulting articles, anticipated in the year 2025.
To whom data/document is available
Access to Protocol and Results: All individuals with access to the resulting articles will be able to use the study protocol and results.
Under which criteria data/document could be used
No Access Under Any Circumstances
From where data/document is obtainable
Contact for Questions: For any questions, please contact the corresponding author via email.
vahidrashedi@yahoo.com
What processes are involved for a request to access data/document