UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008801 |
|---|---|
| Receipt number | R000010337 |
| Scientific Title | Examination of Effective Nursing Intervention for Music Therapy for Severe Dementia Elderly Person |
| Date of disclosure of the study information | 2012/08/29 |
| Last modified on | 2012/08/31 15:06:54 |
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Basic information
Public title
Examination of Effective Nursing Intervention for Music Therapy for Severe Dementia Elderly Person
Acronym
Music Intervention to Improve QOL of Elderly Individuals with Severe Dementia
Scientific Title
Examination of Effective Nursing Intervention for Music Therapy for Severe Dementia Elderly Person
Scientific Title:Acronym
Music Intervention to Improve QOL of Elderly Individuals with Severe Dementia
Region
| Japan |
Condition
Condition
Severe Alzheimer's disease
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Short-term effects
To investigate the utility of music intervention for reducing BPSD, we examined the short- and long-term effects of passive and interactive approaches using individualized music associated with special memories to evoke positive emotions and recollection in elderly individuals with severe dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Short-term effects:
we evaluated immediately before and after the music intervention using the autonomic nerve index and the Faces scale.
Long-term effects:
We evaluated BEHAVE-AD .
The evaluations were conducted prior to the study (baseline), after the tenth music intervention, and 3 weeks after the intervention had ended.
Long-term effects:
we calculated the number of minutes of behavior that indicated responsiveness to the music intervention in the Passive and Interactive groups every session.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The Passive group participants listened to music presented through speakers in own room.The intervention was performed for 30 minutes once a week for 10 weeks (10 sessions in total).we approaches using individualized music associated with special memories.
Interventions/Control_2
The Interactive group participants selected and played music through speakers, and participated in interactive activities (playing, singing, dancing, etc.) with a music facilitator.The intervention was performed for 30 minutes once a week for 10 weeks (10 sessions in total).we approaches using individualized music associated with special memories.
Interventions/Control_3
The Control group participants spent time with caregivers in their own room as usual, without any music intervention (silent environment).
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The selection criteria were as follows. 1.Alzheimer'stype dementia according the diagnostic criteria specified in the Diagnostic and Statistical Manual of Mental Disorders.
2. 4th edition; severity was classified at level 3, indicating severe dementia as specified by the Clinical Dementia Rating scale.
3. aged 65 years or more.
Key exclusion criteria
The exclusion criteria were as follows. 1.acoustic disturbance.
2. experience of playing musical instruments.
3. history of heart disease, hypertension, or diabetes (because changes in autonomic nervous system were used as an index).
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mayumi Sakamoto |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
Address
7-5-10, Tomogaoka, Suma-ku, Kobe-city 654-0142 Hyogo,Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Sakamoto |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
Address
7-5-10, Tomogaoka, Suma-ku, Kobe-city 654-0142 Hyogo,Japan
TEL
Homepage URL
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 08 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Completed
Date of protocol fixation
| 2007 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 29 | Day |
Last modified on
| 2012 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010337
