Home-based Massage by Caregivers for Dementia

April 6, 2022 updated by: CY Song, National Taipei University of Nursing and Health Sciences

Effects of Manual Massage on Improving Behavioral and Psychological Symptoms of Dementia and Sense of Burden Among Caregivers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11219
        • Recruiting
        • National Taipei University of Nursing and Health Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change agitation
Time Frame: before , during and after 8-weeks massage training interventions
Cohen-Mansfield Agitation Inventory (CMAI)
before , during and after 8-weeks massage training interventions
change depression
Time Frame: before , during and after 8-weeks massage training interventions
Cornell Scale for Depression in Dementia (CSDD)
before , during and after 8-weeks massage training interventions
change stress
Time Frame: before , during and after 8-weeks massage training interventions
Perceived Stress Scale(PSS)
before , during and after 8-weeks massage training interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taipei University of Nursing and Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ANTICIPATED)

May 31, 2022

Study Completion (ANTICIPATED)

May 31, 2022

Study Registration Dates

First Submitted

August 8, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (ACTUAL)

August 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTH-109-2-5-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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