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


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 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


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

Value
https://center6.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