Clinical Trials Directory

Trials / Completed

CompletedNCT05272501

CAlming Touch for People With Agitation or Other Behavioural Symptoms of DEMentia - A Randomized Feasibility Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
University College Copenhagen · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

Dementia is an increasing health challenge among elderly citizens in Denmark. An estimated 87,000 Danes live with dementia, and this number is expected to increase to 130,000 in 2030. Psychiatric symptoms and behavioral changes decrease quality of life for patients and their spouses and is a challenge for caretakers. Behavior changes include agitation which can be divided in four sub-groups: 1) physical aggression, 2) physical non-aggression, 3) verbal aggression, and 4) verbal non-aggression. Pharmaceutical management of behavioral changes is common and may be associated with negative side-effects including drowsiness and falls. Though non-pharmaceutical interventions such as music, massage and social activities have been recommended the underlying evidence is limited. In this randomized feasibility trial, we will investigate the feasibility and acceptability of therapeutic touch aiming to reduce agitated behavior in people living with dementia in a nursing home that specializes in the care of people living with severe dementia. The success criteria of this randomized feasibility trial are as follows: 1. Nursing home residents can be recruited and accept the treatment 'CAlming Touch for People with Agitation or Other Behavioral Symptoms of DEMentia' (CADEM) and complete the feasibility project's test protocol. 2. The treatment concept, which involves the nursing staff in charge of the follow-up treatment, can be implemented in practice. 3. The treatment (CADEM) shows a tendency towards less restless and aggressive behavior for demented citizens evaluated based on a validated measuring tool.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCalming TouchThe calming treatment consists of deep pressure massage and gentle facilitation. The therapist works with the vertical axis, center, respiration, body boundaries and the feet.

Timeline

Start date
2021-10-04
Primary completion
2022-12-22
Completion
2022-12-22
First posted
2022-03-09
Last updated
2023-09-07

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT05272501. Inclusion in this directory is not an endorsement.