UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055551 |
|---|---|
| Receipt number | R000063358 |
| Scientific Title | Extracting MT Interactions that Contribute to Clinical Effectiveness in Music Therapy for Elderly People with Dementia |
| Date of disclosure of the study information | 2024/09/20 |
| Last modified on | 2025/10/02 09:43:55 |
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Basic information
Public title
Extracting MT Interactions that Contribute to Clinical Effectiveness in Music Therapy for Elderly People with Dementia
Acronym
Extracting MT Interactions for Elderly with Dementia
Scientific Title
Extracting MT Interactions that Contribute to Clinical Effectiveness in Music Therapy for Elderly People with Dementia
Scientific Title:Acronym
Extracting MT Interactions for Elderly with Dementia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In music therapy for the elderly with dementia, we aim to clarify what kind of "MT interaction (*)" is associated with clinical effects (e.g., reduction of anxiety and depression).
(* MT stands for Music Therapy and "MT interaction" means the approach by the music therapist (e.g., talking to the elderly, conversation, song selection, accompaniment in the key and tempo of the music, etc. ) and the elderly 's response (speech, smile, body movement to the rhythm, etc.)).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Neuropsychiatric Inventory Nursing Home version (NPI-NH),
Ehime Music therapy Scale for Dementia (D-EMS)
Key secondary outcomes
Mini-Mental State Examination (MMSE)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Elderly people with dementia are invited to participate in one hour of music therapy session (remote method) each week at the nursing home they use. This will be done for 6 months.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Elderly persons with dementia who are using a facility for the elderly with dementia.
2.No hearing problems
3.Able to participate in group activities.
4.Able to participate in activities that use music.
Key exclusion criteria
1.Persons under 65 years of age
2.Persons who have not been diagnosed with dementia
3.Persons with hearing impairment
4.Those who are unable to participate in group activities.
5.Those who are unable to participate in activities using music.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Kosugi |
Organization
Senshu University
Division name
School of Network and Information
Zip code
214-8580
Address
2-1-1, Higashimita, Tama-ku, Kawasaki, Kanagawa
TEL
044-911-0511
ksg@isc.senshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Kosugi |
Organization
Senshu University
Division name
School of Network and Information
Zip code
214-8580
Address
2-1-1, Higashimita, Tama-ku, Kawasaki, Kanagawa
TEL
044-911-0511
Homepage URL
ksg@isc.senshu-u.ac.jp
Sponsor or person
Institute
Senshu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee for Life Sciences and Medical Research Involving Human Subjects
Address
2-1-1, Higashimita, Tama-ku, Kawasaki, Kanagawa
Tel
044-911-1253
gakumuka@acc.senshu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063358
