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Home-based Massage by Caregivers for Dementia

Primary Purpose

Dementia, Massage, Burden

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Home-based massage by caregivers for dementia
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Taipei University of Nursing and Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

control group

Arm Description

receive whole body manual massage

After experiment, receive whole body manual massage

Outcomes

Primary Outcome Measures

change agitation
Cohen-Mansfield Agitation Inventory (CMAI)
change depression
Cornell Scale for Depression in Dementia (CSDD)
change stress
Perceived Stress Scale(PSS)

Secondary Outcome Measures

Full Information

First Posted
August 8, 2021
Last Updated
April 6, 2022
Sponsor
National Taipei University of Nursing and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05009147
Brief Title
Home-based Massage by Caregivers for Dementia
Official Title
Effects of Manual Massage on Improving Behavioral and Psychological Symptoms of Dementia and Sense of Burden Among Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
May 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Massage, Burden

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
receive whole body manual massage
Arm Title
control group
Arm Type
No Intervention
Arm Description
After experiment, receive whole body manual massage
Intervention Type
Other
Intervention Name(s)
Home-based massage by caregivers for dementia
Intervention 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.
Primary Outcome Measure Information:
Title
change agitation
Description
Cohen-Mansfield Agitation Inventory (CMAI)
Time Frame
before , during and after 8-weeks massage training interventions
Title
change depression
Description
Cornell Scale for Depression in Dementia (CSDD)
Time Frame
before , during and after 8-weeks massage training interventions
Title
change stress
Description
Perceived Stress Scale(PSS)
Time Frame
before , during and after 8-weeks massage training interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen-Yi Song
Phone
886-2-28227101
Ext
6136
Email
cysong@ntunhs.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen-Yi Song
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taipei University of Nursing and Health Sciences
City
Taipei
ZIP/Postal Code
11219
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen-Yi Song
Phone
886-2-28227101
Ext
6136
Email
cysong@ntunhs.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Home-based Massage by Caregivers for Dementia

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