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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008801
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kobe University Graduate School of Health Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010337

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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