Home-based Massage by Caregivers for Dementia
Effects of Manual Massage on Improving Behavioral and Psychological Symptoms of Dementia and Sense of Burden Among Caregivers
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to investigate the effects of manual massage on improving behavioral and psychological symptoms of dementia and sense of burden among caregivers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 8, 2021
CompletedFirst Posted
Study publicly available on registry
August 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedApril 7, 2022
April 1, 2022
1.4 years
August 8, 2021
April 6, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
change agitation
Cohen-Mansfield Agitation Inventory (CMAI)
before , during and after 8-weeks massage training interventions
change depression
Cornell Scale for Depression in Dementia (CSDD)
before , during and after 8-weeks massage training interventions
change stress
Perceived Stress Scale(PSS)
before , during and after 8-weeks massage training interventions
Study Arms (2)
experimental group
EXPERIMENTALreceive whole body manual massage
control group
NO INTERVENTIONAfter experiment, receive whole body manual massage
Interventions
A total of 40 patients with dementia and their family caregivers will be included and randomly allocated to experiment (n=20) or control group (n=20). The experiment and control group will receive whole body manual massage and placebo intervention (30 minutes once per week for 8 continuous weeks), respectively.
Eligibility Criteria
You may qualify if:
- Over 65 years old, diagnosed with dementia, agitation or depression, irregular massage and exercise habits.
You may not qualify if:
- Those who have open wounds, inflammation, infection, burns and scalds, artificial blood vessels in the hands, or diagnosed as inappropriate for massage in the near future, the severity of symptoms affects the study participants.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taipei University of Nursing and Health Sciences
Taipei, 11219, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chen-Yi Song
National Taipei University of Nursing and Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
August 8, 2021
First Posted
August 17, 2021
Study Start
January 1, 2021
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
April 7, 2022
Record last verified: 2022-04