Home-based Massage by Caregivers for Dementia

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05009147
• Other study ID #: CTH-109-2-5-025
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: April 2022
• Source: National Taipei University of Nursing and Health Sciences
• Contact: Chen-Yi Song
• Phone: 886-2-28227101
• Email: cysong[@]ntunhs.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burden
• Dementia
• Massage

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taipei University of Nursing and Health Sciences	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

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