Direct effects:- Measuring the impact of therapeutich touch/massage at patients with dementie and agitation. Indirectly:- The promotion of the non-verbal communication with the demented elderly in the nursing home. - Offering extra attention as a…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
dementie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
? Cohen-Mansfield agitation questionnaire (CMAI)
? neuropsychiatric questionnaire
? nursing home version (NPI-NH) ? 4 measurings (NPI-NH and CMAI):
Baseline at end first therapy (massage or friendly visit), after washout period
= beginning second therapy and at the end of second therapy (friendly visit or
massage).
Secondary outcome
There are not secundary parameters / outcoms of this study
Background summary
Therapeutic touch or massage is a treatment which is sometimes applied within
the framework of palliatory care at cancer patients or at patients with
dementia. This therapy has not been yet sufficiently scientifically founded at
dementia patients , but is applied because care workers expect that this
treatment is effective. Differently than farmacological treatment for disorder
or agitation, this treatment has according to the expectations not hardly side
effects.
Study objective
Direct effects:
- Measuring the impact of therapeutich touch/massage at patients with dementie
and agitation.
Indirectly:
- The promotion of the non-verbal communication with the demented elderly in
the nursing home.
- Offering extra attention as a result of which the quality of life of patients
with dementia in the nursing home improves.
Study design
? Cross-over trial with intervention duration (massage or friendly visit) of 4
weeks
? Washout period between both interventions of 2 weeks
? massage session are carried out by 2 trained care workers (20-25 minutes, 2
times a week, during 4 weeks) and take place on the chamber of the patient or
in another availabel room.
? Friendly visit consistis on a chat and drink coffee on the room of the
patient by the same care worker
? 2 time 42 dementia patients
? Researcher is not aware about the intervention (is not informed about who
gets the massage or the friendly visit)
Poweranalyse: Given alpha of 0.05, a beta of 0.8, an expected impact size
(change in CMAI of total 4 points), SD (of the change in CMAI) of 13 and a
correlation between two measurings of r = 0.54 are there 2 time 39 people
necessary. Taking into account outburst negative of 5% will be started with 2
time 42 people.
Intervention
Massage/TT session carried out 2 care workers trained by (20-25 minutes, 2 time
per week, during 4 weeks).
Massage/TT session take place on the room of the patient or in another
available room.
Study burden and risks
Therapeutic touch/massage have none risico' s. There are possibly patients who
not appreciate this intervention. When the patient gives up verbally or
non-verbally that he/she doesn't want the treatment, the caregiver stop the
treatment (massage). When this happens a second time the treatment stops
definitely and the patient is taken out of the reaserch(dropout in
intention-to-treat the analysis).
Dongepark 1
5102 DB
Nederland
Dongepark 1
5102 DB
Nederland
Listed location countries
Age
Inclusion criteria
- Dementia (acoording to DSM-IV criteria)
- Agitation (according to the CMAI score above 44 points).
Exclusion criteria
- No agitation
- Recent diseases (for example;urinary tract infections, pneumonia, etc).
- Recent changes in the medication (not longer than 7 days before starting with the trial).
- Terminal patients.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25358.091.08 |