ROMA (Reminiscence, Reality Orientation, Music and Art ) Therapy, Cognition, Depression and Behavioral Problems in the Population With Dementia

NCT ID: NCT04507633

Last Updated: 2022-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-25

Study Completion Date

2021-07-31

Brief Summary

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This study aimed to conduct a randomized controlled trial to examine the effectiveness of ROMA therapy( Reminiscence, Reality Orientation, Music, and Art) on improving cognitive function, behavioral and psychological symptoms in population with dementia. The hypotheis of this study is that these patients with dementia receiving ROMA therapy featuring reminiscence, reality orientation, music, and art would improve their cognition, depressive symptoms, and behavioral symptoms.

Detailed Description

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This study aimed to conduct a randomized controlled trial to examine the effectiveness of ROMA therapy( Reminiscence, Reality Orientation, Music, and Art) on improving cognitive function, behavioral and psychological symptoms in demented population. A total of 60 patients with mild to moderate dementia will be recruited and randomly assigned to two groups: experimental group and control group. The experimental group will undergo ROMA therapy with a 60 minute per week for eight weeks. The control group will receive three times ROMA therapy after completing outcome measurements. Two groups will receive questionnaire interview at pre-test, post-test, and at 4 weeks after intervention. The measurements comprises: Short Portable Mental Status Questionnaire(SPMSQ), Cornell Scale for Depression in Dementia(CSDD),and Neuropsychiatric Inventory-Questionnaire(NPI-Q). By identifying the effectiveness of ROMA therapy, suitable intervention can be suggested for those demented population to improve cognitive function, behavioral and psychological symptoms.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
independent researchers will perform intervention and data collection.

Study Groups

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ROMA therapy

ROMA therapy combines four elements including reminiscence, reality orientation, music, and art in the intervention.

Group Type EXPERIMENTAL

ROMA therapy(reminiacence therpy, orientation, music, and art)

Intervention Type BEHAVIORAL

An intervention comprising reminiscence of annual festivals, orientation, and familiar music listening and singing, and animation interaction to improve cognitive functions, depressive symptoms and behaviors problems.

control group

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ROMA therapy(reminiacence therpy, orientation, music, and art)

An intervention comprising reminiscence of annual festivals, orientation, and familiar music listening and singing, and animation interaction to improve cognitive functions, depressive symptoms and behaviors problems.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Been diagnosed as mild to moderate dementia and CDR score between 0.5\~2
2. can communicate in Chinese or Taiwanese
3. without visual or auditory impairment after equipping assist devices

Exclusion Criteria

1. severe dementia and Clinical Dementia Rating (CDR) score more than 2 points
2. functional dependence
3. incapable of expressing their feelings
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Huang, Hui-Chuan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hui-Chuan Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, Taipei Medical University

Locations

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Yonghe Zhongxing Public Seniors Center

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

References

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Tz-Han L, Wan-Ru W, I-Hui C, Hui-Chuan H. Reminiscence music intervention on cognitive, depressive, and behavioral symptoms in older adults with dementia. Geriatr Nurs. 2023 Jan-Feb;49:127-132. doi: 10.1016/j.gerinurse.2022.11.014. Epub 2022 Dec 8.

Reference Type DERIVED
PMID: 36495795 (View on PubMed)

Other Identifiers

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N202005108

Identifier Type: -

Identifier Source: org_study_id

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