The present study aims to address the limitations of earlier research, by employing a large sample size, and investigating the possibility that music therapy has an effect on wellbeing of people with dementia when using blinded outcome assessments…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Well-being is measured with the Discomfort Scale - Dementia of Alzheimer Type
(DS-DAT).
Secondary outcome
1. Pain will be assessed with PAIC-15.
2. The Quality of Life in Late-Stage Dementia Scale (QUALID).
3. Neuropsychiatric symptoms are assessed with the Neuropsychiatric Inventory
Nursing Home Version (NPI-NH).
4. Anxiety will be derived from the NPI-NH item *anxiety*.
5. Agitation and aggression will be assessed using the caregiver-rated
questionnaire Cohen-Mansfield Agitation Inventory (CMAI).
6. Symptoms of depression will be recorded using the caregiver-rated Cornell
Scale for Depression in Dementia (CSDD).
7. Quality of sleep will be determined using an Actiwatch, which is a small
activity monitor. It will be worn on the dominant wrist the week before the
intervention started (T0) and the week directly after the last intervention
session (T2).
8. Psychotropic drug use. Data on chronic and pro re nata (as needed) use will
be derived from the electronic chart. Psychotropics will be categorized into
antipsychotics, anxiolytics, hypnotics, antidepressants and anti-dementia drugs
according to the Anatomical Therapeutic Classification (ATC) system.
Background summary
Neuropsychiatric symptoms (NPS), such as agitation, aggression, shouting and
wandering, are often associated with a distress for the patient with dementia
and emotional burden for his/her environment. The symptoms are often treated
with psychotropic drugs. However, these are often associated with side effects.
Non-pharmacological treatments are therefore necessary to improve the quality
of life in these individuals. Music therapy might be a non-pharmacological
treatment for this problem.
Study objective
The present study aims to address the limitations of earlier research, by
employing a large sample size, and investigating the possibility that music
therapy has an effect on wellbeing of people with dementia when using blinded
outcome assessments and adjustment for individual contact during therapy
sessions. The main aim of this study is to assess the effects of individual
music therapy on the well-being comparing to individual attention through RCT
(randomized controlled trial) research in nursing home residents with dementia
and neuropsychiatric symptoms (NPS).
Study design
The design involves an individual randomized controlled trial employing
longitudinal repeated measurements in nursing home residents with dementia and
neuropsychiatric symptoms (NPS). The research will take place at different
facilities of one nursing home organization (Amstelring). All music therapists
are trained and credentialed professionals. An independent observer (blind)
will determine the effect of individual music therapy in patients with dementia
through music therapy sessions before and after observing.
Intervention
The participants of the intervention group (MT) receive 30 minutes of
individual music therapy twice a week for 12 weeks in their own room. Patients
receive an individually tailored session in which the music therapist chooses
the means to influence the behavioural problem.
Study burden and risks
Patients may experience the therapy as unpleasant or tiring. As soon as the
music therapist notices that the therapy is too burdensome or not pleasant for
the participant, the treatment will be stopped immediately.
Huispostcode FA21
Groningen 9700 AD
NL
Huispostcode FA21
Groningen 9700 AD
NL
Listed location countries
Age
Inclusion criteria
Chart diagnosis of dementia
Clinically relevant neuropsychiatriec symptoms
Exclusion criteria
Never received individual music therapy and received no group music therapy
during the last 3 months
No major comorbid psychiater diagnosis (ie schizofrenie, psychosis, anxiety
disorders).
No hearing problems
Design
Recruitment
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 | NL68639.042.18 |
| Other | NL7708 |