Home-based Massage by Caregivers for Dementia
Sponsor
National Taipei University of Nursing and Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05009147
Collaborator
(none)
40
1
2
16.9
2.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Effects of Manual Massage on Improving Behavioral and Psychological Symptoms of Dementia and Sense of Burden Among Caregivers
Actual Study Start Date
:
Jan 1, 2021
Anticipated Primary Completion Date
:
May 31, 2022
Anticipated Study Completion Date
:
May 31, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: experimental group receive whole body manual massage |
Other: Home-based massage by caregivers for dementia
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.
|
| No Intervention: control group After experiment, receive whole body manual massage |
Outcome Measures
Primary Outcome Measures
- change agitation [before , during and after 8-weeks massage training interventions]
Cohen-Mansfield Agitation Inventory (CMAI)
- change depression [before , during and after 8-weeks massage training interventions]
Cornell Scale for Depression in Dementia (CSDD)
- change stress [before , during and after 8-weeks massage training interventions]
Perceived Stress Scale(PSS)
Eligibility Criteria
Criteria
Ages Eligible for Study:
65 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Over 65 years old, diagnosed with dementia, agitation or depression, irregular massage and exercise habits.
Exclusion Criteria:
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Taipei University of Nursing and Health Sciences | Taipei | Taiwan | 11219 |
Sponsors and Collaborators
- National Taipei University of Nursing and Health Sciences
Investigators
- Principal Investigator: Chen-Yi Song, National Taipei University of Nursing and Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
CY Song,
Prof,
National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier:
NCT05009147
Other Study ID Numbers:
- CTH-109-2-5-025
First Posted:
Aug 17, 2021
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: