In What Way do Music-based Caregiving Influence Pain, Daily Activity, QOL, Neuropsychiatric Symptoms, and Medication in Patients With Dementia
Phase: NA
Conditions: Pain, Dementia, Music, Activity, Motor, Quality of Life
Sponsor: Oslo University Hospital

1.Title: In what way do music-based caregiving influence pain, daily 
activity, neuropsychiatric symptoms, and medication in patients with 
dementia?  
 
  
Protocol approved by the Regional Comittees for Medical Research Ethics 
South East Norway, REK South East at 25.06.2019 
 
NCT-number NCT04229446 
ID: 2018/2519 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
2. Introduction  
 
The main objective of this study is to evaluate the pain-relieving effect 
of a well-characterized  
non-pharmacological treatment program, music-based caregiving (MBC), to 
patients in  
nursing homes with dementia and pain. This intervention study will apply 
for one PhD  
candidate. Patients with dementia disease will be recruited from eight 
different nursing homes  
in Trondheim and Oslo, and each ward will be cluster randomized into 
intervention - or  
control wards. Then the health care personnel in the intervention wards 
will receive education  
in MBC and perform the intervention during eight weeks. The hypothesis is 
that this non- 
pharmacological intervention will reduce pain intensity and improve the 
activity of daily  
living (ADL), quality of life (QOL) and general activity, as well as 
reduce other symptoms in  
nursing home patients with dementia and pain compared to baseline.  
 
Background  
 
Pain is common in the elderly, and the prevalence of pain increase with 
age, co-morbidities  
and frailty 1,2. While the prevalence of pain in older adults in the 
general population is  
estimated to range from 25%-50% 2-4, the prevalence of pain in patients 
living in nursing  
homes and community care varies from 28% to 87% 5,6. Musculoskeletal pain 
disorders have  
been estimated to affect as many as 80% of those above 65 years 7,8. 
Although almost one  
fifth of the elderly have symptomatic osteoarthritis 9, most of the 
chronic pain disorders are of  
unknown cause 10. Thus opioids are not the best treatment with unclear 
effect over time and  
serious side effects (sedation, dizziness, falls, dysphoria, obstipation) 
in the elderly 11. This  
knowledge is in contrast to the practice today. In Denmark, 41% of 
nursing home residents  
and 28% of home-domiciled patients with dementia use opioids 12.  
 
Previous studies demonstrate that more than 80% of patients in nursing 
homes in  
Norway had dementia disease 13,14. Dementia is a syndrome due to disease 
of the brain,  
usually of a chronic and progressive nature, in which there is 
disturbance of multiple higher  
cortical functions, including memory, reasoning, orientation, 
comprehension, calculation,  
learning capacity, language, and judgement 15. Dementia has different 
stages; mild, moderate  
and sever dementia. In severe dementia (disease), most of the patients 
have lost verbal  

language and are dependent on of nursing care 15. Patients with dementia 
also experience  
many severe neuropsychiatric symptoms. SelbÃ¦k et al 16 followed 931 
nursing home patients  
with dementia over time. Agitation, irritability, disinhibition, and 
apathy were the most  
prevalent and persistent symptoms during the study period. Depression and 
anxiety became  
less severe over time, whereas the agitation subsyndrome (agitation 
/aggression, disinhibition,  
and irritability) and apathy increased in severity during the follow-up 
period.  
 
Pain is under-reported in the elderly since the elderly or the health 
care personnel do  
not report pain, and because of failure of regular and systematic pain 
assessment in the health  
care system 17. Pain assessment is challenging in the elderly because of 
impaired vision and  
hearing, memory, verbal and cognitive functions, and neuropsychiatric 
symptoms. If not  
adequately treated, chronic pain can cause depression, agitation, and 
aggression in patients  
with dementia 18. Given the language loss in the most advanced stage of 
dementia and  
sometimes after stroke, a cause of dementia, valid and reliable methods 
for pain assessment in  
nonverbal older adults are needed 19. MOBID-2, an observation based pain 
assessment tool,  
will be used in patients with dementia in the present study. MOBID-2 is 
validated in nursing  
homes patients with dementia in Norway 6,20.  
 
 Based on current knowledge, non-pharmacological interventions should be 
the first- 
line treatment approach for pain in most cases for patients with dementia 
18. Since  
pharmacological treatment for chronic pain is often inadequate and the 
elderly are prone to  
 
 
 

side-effects, more evidence about non-pharmacological treatments is 
needed, especially for  
elderly with dementia. Many studies are conducted in this area today, but 
unstructured and  
non-evidence based interventions are commonly used 21 Based on current 
knowledge, non- 
pharmacological interventions should be the first-line treatment approach 
for pain in most  
cases for patients with dementia 18. Since pharmacological treatment for 
chronic pain is often  
inadequate and the elderly are prone to side-effects, more evidence about 
non- 
pharmacological treatments is needed, especially for elderly with 
dementia. Many studies are  
conducted in this area today, but unstructured and non-evidence based 
interventions are  
commonly used 21. One of the most common non-pharmacological approaches 
for treating  
behavioral and psychological symptoms of dementia is therapeutic use of 
music 22(. Many of  
the studies done have low methodological quality with small sample sizes 
23, but there seems  
to be some evidence (for) that non-pharmacological interventions like 
activity and music can  
relieve pain 24, depression25 and increase QoL 23. However, more research 
is needed using  
controlled studies of high quality 23.  
 
 The most convincing evidence of effect when reviewing interventions 
addressing QOL,  
discomfort and behavior and psychiatric symptoms in person with dementia 
comes from  
functional analysis-based interventions 26. These rely on the nursing 
home staff to implement  
a care system, be involved in staff-education, protocol or systematic 
care planning. Examples  
of such interventions are the ABC dementia, Serial-trial intervention and 
(the) TIME 27-29.  
These interventions prove to be powerful and important systems to 
structure care-work,  
deliverance and education, however they are comprehensive systems to 
implements and not  
designed to inform on one specific symptom like pain. That is also why 
there is a shortage of  
functional analysis-based interventions targeting pain intensity 
specifically.  
 
The literature suggests that music may also provide effects for pain 
intensity for  
patients with dementia 30. However, so far the studies are small, 
underpowered or performed  
with less robust methods 31. A review that investigated whether 
interactive or receptive  
deliverance (i.e. listening to) of music are more effective to reduce 
agitation in persons with  
dementia found evidence that receptive deliverance does reduce agitation 
compared to  

ordinary care, while interactive deliverance of music does not 32. In a 
recent review on non- 
pharmacological treatments for individuals with dementia, sensory 
interventions like music  
were most effective to reduce agitation followed by interventions 
targeting pain specifically  
33. The evidence might suggest that music reduces stress due to sensory 
effects and by  
activating reminiscing.  
 
Physical activity and active training has been investigated in persons 
with dementia  
and have been able to prevent falls, improve physical and mental function 
and also  
neuropsychiatric symptoms 34. There is currently a dearth of studies to 
provide information on  
what interventions have proved to benefit pain intensity, and also 
looking at effects by age,  
gender, type and grade of dementia 21. The physiological and 
psychological effects of music  
have been thoroughly researched in later years. Precise therapeutic use 
of music can aid  
attention, regulate autonomic dysregulation and access latent functional 
mental resources 35.  
 
Music-based caregiving (MBC) has been developed through a dialogue 
between  
neuroscience and clinical research in dementia care since the early 
1990s, inspired by the  
work of Michael Thaut and Linda Gerdner 36,37. Thaut and Gerdnerâ€™s work 
has demonstrated  
the clinical potential and efficacy of neurologic music therapy and 
individualized music 38.  
MBC has (been) continually built on neuroscientific research in 
continuing dialogue with the  
Center for Biomedical Research at Colorado State University, Berklee 
School of  
Music/Harvard Medical School in Boston and the neuroscientific work of 
TÃ¶res Theorell and  
associates at Karolinska Sjukhuset in Stockholm 39. The PhD project -
Integrated music in  
nursing homes, an approach to dementia care, developed song, music and 
dance into a  
systematic approach to dementia care through the period 2000â€“2012 40.  
 
 
 

MBC provides in- 
depth training on how music, song and movement can be used in caregiving  
for people with dementia. The program has been developed on behalf of the 
Norwegian  
Directorate of Health and is based on neurological music therapy with 
elements of music  
therapy and music education, and added to KompetanselÃ¸ft 2020.  
 
 
2.1 Need description  
 
ï‚· Increased focus on pain and non-pharmacological pain management in a 
vulnerable group  
of patients  
ï‚· The non-pharmacological intervention can reduce pain intensity and 
strengthen ADL,  
QOL and activity, reduce pharmacological side effects and reduce symptoms 
in nursing  
home patients with dementia and pain without side effects.  
ï‚· Reliving pain without side effects will also be valuable for the 
patientâ€™s family.  
ï‚· This study will increase the focus on pain and pain management for 
health care  
professionals in nursing homes and the community. The training of the 
staff in the  
intervention nursing homes will enhance their clinical skills.  
ï‚· This increased competence can strengthen the motivation for the staff 
in the care of the  
patients with dementia, and may reduce the turnover of the staff. 
Hopefully it can also  
stimulate their wish for knowledge update.  
ï‚· The health professionals in the intervention group will receive 
education in a program  
with music, song and dance with the intention to reduce pain, and 
strengthen ADL, QOL  
and activity, reduce side effects and reduce symptoms in nursing home 
patients with  
dementia and pain. If the intervention shows effect, the health care 
professionals in the  
control nursing homes will retain and, hopefully use, the training after 
the study is ended.  
ï‚· The research group is multi-professional from different research 
groups in Norway. All of  
the nurses, physicians, experts in epidemiology, music therapy, and user 
participants work  
together. This collaboration will strengthen the research competence for 
the group and for  
the different members.  
 
 
  
 
3.Aims and objectives  
 
The overarching aim of the present study is to extend knowledge about 
pain in patients with  
dementia and to evaluate if an intervention with music-based caregiving 
(MBC) will reduce  

pain intensity and improve activity and QoL in nursing home patients with 
dementia and pain.  
 
The baseline descriptions of pain and pain management in patients with 
dementia disease in  
the included nursing homes will be published as a part of another study.  
 
The research questions in the present study are:  
 
1. Will music based caregiving reduce pain and the need for analgesics in 
patients with  
dementia in nursing homes?  
2. Will music-based caregiving impact on QoL, ADL function, and total 
daily physical  
function?  
3. Will implementation of music-based caregiving impact on 
neuropsychiatric symptoms  
and psychopharmacological medication?  
 
 
  
 
The primary aim is to give better and safer pain management to patients 
with pain and  
dementia in nursing homes.  
 
Secondary aims are:  
 
- to increase total daily activity, ADL function, QoL, and reduce 
neuropsychiatric  
symptoms, and  
 
- to increase knowledge of pain in patients in nursing homes: the 
occurrence, intensity,  
location, treatment, diagnoses, and comorbidities.  
 
 
 

  
 
4. Project methodology  
 
4.1. Design, method and analysis  
 
This is a cluster-randomized controlled trial including patients with 
dementia and pain living  
at different wards at eight nursing homes.  
 
1) Eight nursing homes will be selected to participate, four in Trondheim 
and four in Oslo.  
Both municipalities have accepted the collaboration, and contact has 
already been  
established with randomly selected nursing homes.  
2) Subsequently, all patients at the 8 nursing homes will be screened 
with respect to  
dementia and pain (see screening tools later). If patients have dementia 
and report pain  
(â‰¥3 on MOBID) they will be included in the study.  
3) The included patients will then have a clinical examination of pain 
and pain management  
by an expert physician (see below). Evaluation of the use of analgesics  
psychopharmacological medication will be performed. Inappropriate 
medication (both too  
much and too little) will be corrected in collaboration with the nursing 
home doctor.  
4) In addition to the clinical examination of pain, we will measure total 
daily physical  
activity, ADL, QOL, and neuropsychiatric symptoms on all included 
patients (see below).  
5) After the pre test - a randomization of the wards into intervention 
wards or control wards  
will be performed.  
6) About 5 staff members at each of the wards randomized to the 
intervention group will  
receive education in the MBC before intervention (see below).  
7) As a post-test three month after the intervention has ended, pain, 
total daily physical  
activity, ADL, QOL, and neuropsychiatric symptoms will be measured.  
 
 
  
 
This design facilitates the measurement of the outcome variables in 
nursing homes patients  
before and after the intervention, and between the two groups. The 
results from the pre- and  
post-tests will be compared between the groups to assess whether or not 
the intervention has  
effects on the outcome variables when adjusting for baseline levels (pre-
test). This approach  
will allow us to evaluate whether changes in the outcome measure are 
caused by the  
intervention or other elements.  
 
  
 

Participants  
 
In total, 240 patients with dementia and pain (120 from nursing homes in 
Trondheim and 120  
from nursing homes in Oslo) will participate in the study. Contact is 
already established with  
nursing homes that will participate both places. Patients will be 
included if they report  
moderate pain or more (â‰¥3 on MOBID) and mild dementia or more (â‰¥1 on 
CDR). They will  
not be included if they have lived in the nursing home less than four 
weeks, have short (less  
than eight weeks) expected lifetime (judged by the nurses), and if they 
do not understand the  
Norwegian language. Anonymous data will be collected for comparing 
patients not included  
with those included, and the reasons for why they were not included will 
be described. Before  
inclusion in the study, patients or their relatives should give an 
informed consent.  
 
  
 
Clinical examination  
 
All the included patients will be clinically examined by expert 
physicians in the same way as  
performed in the HUNT3 study 10. Focal pain conditions will be diagnosed 
according to the  
10th revision of the International Statistical Classification of Diseases 
and Related Health  
Problems 41, either as a disease diagnosis, or, if no cause of the pain 
can be identified, by a  
pain/symptom diagnosis. In addition, the physician will make a critical 
evaluation of their  
analgesic and other medications as mentioned above. If medications are 
inadequate, obviously  
give side effects, or are in violation with current guidelines, the 
recommendation for  
 
 
 

correction will be given to the physician at the nursing home. This 
procedure will particularly  
be the case for all patients having a pain state of known origin with 
documented effect of  
specific medication (i.e. osteoarthritis or neuropathic pain).  
 
  
 
Education of the health care professionals  
 
After pre-test including clinical examination, a randomization of the 
wards into intervention  
wards or control wards will be performed. About 5 staff members at each 
of the wards  
randomized to the intervention group will receive education in the MBC. 
Approximately 60  
employees will receive training in MBC by Myskja and HÃ¥pnes with a 5-day 
training course.  
This training will facilitate the intervention in the way that the health 
professionals in the  
intervention group will be competent in applying active (song, dance) and 
passive (music  
listening) modalities in individualized music with groups and individuals 
as needed, mindful  
of personal preference and dignity and aware of the sensory environment.  
 
  
 
The MBC program  
 
The MBC program has been developed as a hermeneutic circle (interpreted 
from the Vedic  
scriptures) 42, expanding from literature reviews and teaching sites to 
observations of clinical  
response, aided by video analyses. The Medical Research Council 
guidelines have been  
followed in this process, using the cyclical stages of development, 
feasibility and piloting,  
evaluation, and implementation 43. In the period from 2012, 490 health 
care workers have  
been educated in this program in TrÃ¸ndelag.  
 
  
 
Intervention  
 
The intervention will be applied by the trained staff with daily 
individualized prerecorded  
music integrated with activity with about 30 minutes duration, combined 
with a one hour  
active session in groups twice weekly. The control group will receive 
regular treatment with  
the same improved analgesic treatment as the intervention group, but 
without MBC. The  
duration of the intervention and the control period will be eight weeks.  
 
  
 

Measurements  
 
As a part of the pre-test we will select data about the patientsâ€™ 
demographics, diagnoses and  
medication use from the medical chart.  
 
  
 
Stage of dementia disease  
 
Clinical Dementia Rating Scale (CDR) is an assessment scale for the 
accurate clinical staging  
of dementia in older subjects. The CDR includes six items assessing 
cognitive and functional  
impairment. Based on an algorithm giving precedence to the item memory a 
CDR total score  
is estimated. A score of 0, 0.5, 1, 2, 3 indicates no dementia, 
questionable dementia, mild,  
moderate or severe dementia, respectively, and CDR score > 1, is cut-off 
score for dementia  
disease. The scale has shown to be reliable and valid and is translated 
into Norwegian  
language 44.  
 
  
 
Pain  
 
MOBID-2 pain scale will be used for pain assessment in elderly people 
with dementia 20,45.  
The assessment of inferred pain intensity is observed based on 
patientâ€™s pain behaviors during  
standardized, guided movements of different body parts (Part 1). In 
addition, MOBID-2  
includes an observation of pain behavior related to internal organs, head 
and skin registered  
on pain drawings and monitored over time (Part 2). MOBID-2 has shown to 
be sufficiently  
reliable, valid and time-effective to assess pain in patients with severe 
dementia 46. We will  
use MOBID-2 for assessment of pain in all the patients with dementia.  
 
 
 

  
 
Quality of life and aids of daily living  
 
Quality of Life in Late-Stage Dementia (QUALID) measures QOL in patients 
with severe  
dementia based on information and observations from nurses about the 
patientâ€™s emotions and  
behavior. The scale has been validated in a Norwegian nursing home 
population, showing  
satisfactory psychometric properties 47,48.  
 
Dementia Quality of Life (DQoL). Because QUALID-scale is an observation 
scale, and there  
is a lack of studies comparing self-reported and observations QoL in 
those with dementia, we  
want to compare the observation estimate with self-report for patients 
with none, mild and  
moderate dementia (DQoL). DQoL consists of five domains: self-esteem, 
positive affect/  
humor, feeling of belonging, and sense of aesthetics and negative affect. 
The instrument is  
evaluated in those with mild and moderate dementia and is used in nursing 
homes in Norway  
49.  
 
Barthelâ€™s Activities of Daily Living Index (ADL) is a screening 
instrument for patientsâ€™ daily  
life functioning. This 10-point scale measures patientsâ€™ degree of 
self-reliance with a total  
score ranging from 0 to 20. Lower scores indicate greater dependence on 
nursing care 50.  
 
The total daily physical activity using two 3-axis accelerometers 
(Axivity, UK) attached to the  
skin on the right thigh and low back for 7 continuous days. By utilizing 
state-of-the-art  
machine-learning techniques, we have developed a preliminary activity 
recognition model for  
lying, sitting, standing, walking and other activities. This model is 
being used in the Nord- 
TrÃ¸ndelag health study (HUNT4). Specifically, the model captures walking 
velocity and  
transitions between postures and activities (e.g. sit-to-stand) and sleep 
quality/duration.  
 
  
 
Neuropsychiatric symptoms and depression  
 
The Neuropsychiatric Inventory (NPI-NH) measure 12 different psychiatric 
symptoms and  
behavioural disturbances in nursing home residents: delusions, 
hallucinations, dysphoria,  
anxiety, agitation/aggression, euphoria, disinhibition, 
irritability/lability, apathy, aberrant  
motor activity, sleep and night-time behaviour disorders, appetite and 
eating disorders. The  

screening question is asked to determine if the behavioural change is 
present. If a screening  
question is present, there will be sub-questions about frequency (score 1 
to 4) and intensity  
(score 1 to 3) for each behavior. Total score for each behavior is from 1 
to 12. The scale has  
been validated for patients in nursing homes in Norway 51.  
 
Cornell scale for depression in dementia assesses signs and symptoms of 
major depression in  
patients with dementia in an interview with the health care providers. 
The scale consists of 19  
items in five domains based on observation of behaviour 52. Each question 
is scored on a two- 
point scale: 0=absent; 1=mild or intermittent; 2=severe; n/a = unable to 
evaluate 2.  
 
  
 
Sample size  
 
A power calculation was performed on MOBID-2. Based on the literature 
review we assumed  
the mean difference to be 1.2 and the common standard deviation to be 3. 
To keep statistical  
power of 80% (beta = 0.2) and significance level of 5%, we would need 100 
in each group to  
reveal the anticipated difference between the groups as statistically 
significant. Taking in  
consideration the possible cluster effect of 20% we aim to enrol 120 
patients in both groups  
20,53,54.  
 
  
 
Statistical analyses  
 
Participantsâ€™ background characteristics will be described as means and 
standard deviations  
(SD) for normally distributed continuous data or medians and range for 
continuous data with  
skewed distributions. Categorical data will be presented as counts and 
percentages. At the pre- 
test, possible between-group differences will be assessed using 
independent samples t-tests  
 
 
 

when comparing pair of normally distributed continuous variables, chi-
square test for  
categorical variables and Mannâ€“Whitney test for continuous variables 
with skewed  
distribution. Possible differences between the groups concerning the mean 
MOBID-2 Pain  
Scale, QoL, ADL, total daily physical activity, and neuropsychiatric 
symptoms scores over  
time and at given time points will be estimated with linear random 
intercept quantile mixed- 
effect models. Mixed model regression modelled with linear random 
intercept permits  
multiple measurements per person over time, irregular intervals between 
measurements and  
allows for incomplete data on assumption that data are missing at random 
55. A significance  
level of 5 % will be considered statistically significant for all 
analyses. Data will be analyzed  
using IBM Statistical Package for the Social Sciences (SPSS) version 23.  
 
  
 
4.2. Participants, organization and collaboration  
 
The multi-professional research group will unite clinical and scientific 
experience from four  
different universities (for more details and contribution to the study, 
see e- application):  
 
Petter Chr. Borchgrevink, MD, PhD (principal investigator, main 
supervisor). Leader of "Pain  
research group". Head of "Dept of Pain and Complex Disorders" at 
St.OlavÂ´s Hospital and  
Professor of Anesthesiology and Pain Management at NTNU. Leader of the 
Norwegian Dept  
of Health-defined "Pilot Project for Joint Multidisciplinary Diagnosis 
Centers / Outpatient  
Clinics for Patients With Chronic Pain and/or Fatigue Disorders of 
unknown cause". Has 118  
scientific publications and supervised 9 candidates on their PhD.  
 
Tone RustÃ¸en Professor, RN, PhD (co supervisor). She has 128 scientific 
publications, and  
has been the main supervisor for 12 PhD candidates that have completed 
their PhD. RustÃ¸en  
is a professor at University of Oslo and a researcher at Oslo University 
Hospital. She has a  
long experience with pain research and is the leader of the Regional 
Research Network  
NORSMAN funded by Helse SÃ¸r Ã˜st.  
 
Karin Torvik RN, PhD. Associate professor, NTNU, Nord University, Faculty 
of Health and  
Nursing, Levanger, Norway (co-supervisor). She has a long experience in 
guiding master and  
bachelor students. Her research area is pain assessment and pain 
management in the elderly.  
 

Geir SelbÃ¦k MD, PhD, professor (co supervisor): He has 134 scientific 
publications. He has  
supervised 7 candidates on their PhD, and is currently supervising 10 PhD 
candidates. He is  
the primary investigator for several large-scale clinical studies, 
nationally and internationally.  
His research experience spans a wide variety of fields including basic 
medicine,  
epidemiological studies, clinical trials. This year he was awarded the 
Norwegian dementia  
research prize by the Norwegian Health Association.  
 
Audun Myskja MD, PhD. Advisor to The Norwegian National Resource Center 
for Arts and  
Health. He is a strong and important voice in the traditional academic 
setting, seeking to  
create simple practice-based methods to connect science and the fields of 
the common human  
experience, expanding the context of traditional Western medicine. He has 
long experience  
with innovative use of musical elements in rehabilitation of dementia and 
Parkinsonâ€™s  
patients, and for creating systematic tools for empowerment in persons 
with chronic illness.  
 
Vegar Rangul PhD, Associate professor/Post.doc. HUNT Research Centre, 
Department of  
Public Health and Nursing, Faculty of Medicine, NTNU. Is a specialist in 
physical activity  
epidemiology and has extensive experience with the use of large 
epidemiological data sets to  
resolve issues relating the health effects of physical activity and their 
interaction with general  
health behavior and cardiovascular disease risk in particular. Has 
expertise in behavioral  
epidemiology, measurement of physical activity and epidemiological 
population studies.  
 
Odd HÃ¥pnes, General manager of the Norwegian Resource Center for Arts 
and Health, NORD  
University. He holds a master of musicology, education-in-science and 
education and has  
been central in the development of MBC as a national program. He has been 
the head of the  
 
 
 

national node for culture and health 2000-2003, and participates in 
international cooperation  
and research networks in Arts and Health.  
 
Reidun Sandvik RN, PhD. Associated professor, Western Norway University 
of Applied  
Sciences and University of Bergen. She has experience with supervising 
master students. Her  
PhD topic was pain in nursing home patients with dementia and she has 
continued with  
research about pain management for this group of patients.  
 
Milada C SmÃ¥stuen PhD, biostatistician. Will help with data management 
and statistical  
analyses for the whole study and all three papers.  
 
  
 
4.3. Budget  
 
We will apply for one doctoral student. For details se the electronic 
application (esÃ¸knad).  
 
4.4. Plan for activities, visibility and dissemination  
 
Timeline - see electronic application  
 
Publication plan The most important results to emerge from the project 
will be disseminated  
through different channels. The PhD student will write 3 scientific 
papers:  
 
a) The effect of music based caregiving on pain and the need for 
analgesics in patients with  
dementia in nursing homes.  
 
b) The effect of music-based caregiving on QoL, ADL function, and total 
daily physical  
function.  
 
c) The effect of music-based caregiving on neuropsychiatric symptoms and  
psychopharmacological medication.  
 
  
 
Workshop, seminars and conferences: It is important that leaders in 
community health care  
and individuals in charge of nursing homes have access to our results. To 
facilitate this, we  
will arrange workshops and seminars to present our results. The PhD 
student will participate  
in at least two international and one national conference during their 
study period, presenting  
her/his work. â€œNasjonalforeningen for folkehelsenâ€• will assist in 
sharing our results to users  
and to the general public.  
 
  

 
4.5. Plan for implementation  
 
As the study is an intervention study it can easily be implemented into 
practice if the results  
are positive. The results from the present study will also be 
transferable to other patient  
groups that cannot communicate their pain. The findings from the present 
study will be  
relevant outside nursing homes as these patients also are in specialist 
hospitals and in the  
community.  
 
  
 
5. User involvement  
 
 
Hans HÃ¸gh Henrichsen is user participant from Oslo Municipal. He has 
been informed about  
the proposal in a meeting. The project was also discussed with 
â€œSykehjemsetatenâ€•, Oslo  
Municipality (Torunn Vatne). From Trondheim, one patient with dementia 
and one relative of  
one patient with dementia will be recruited from the Resource Center for 
Dementia Disease in  
Trondheim and will be user participants. All participants will be 
involved in the detail  
planning of all phases of the project. The National Association for 
Public Health, which has  
given feedback on the application, will also recruit user participants 
from the local dementia  
associations if the study should be funded.  
 
  
 
6. Ethics  
 
 
After permission to include the nursing homes, meetings will be arranged 
with the staff to  
inform and motivate them for carrying out the study. The health care 
providers will collect  
 
 
 

written or oral informed consent from the patients and/or their legal 
guardians or relatives. We  
will use different inclusion procedures depending on the patientsâ€™ 
consent competence in  
collaboration with the Ethical Committee.  
 
Patients with consent competence will receive oral and written 
information prior to the study,  
and the nurses will obtain written informed consent. If the patients 
cannot sign, they will give  
oral consent to the nurse, and the nurse will sign the informed consent 
on behalf of the  
patients. If the patients are cognitively impaired, guidelines from the 
Ministry of Health and  
Care Service in Norway will be followed when recruiting these patients. 
Relatives of patients  
or their legal guardians will receive written information prior to the 
study and consent on their  
behalf. The cognitively impaired patients will receive oral information 
prior to the study and  
will not be included if they decline to participate, even if their 
relatives/legal guardians had  
consented on their behalf.  
 
One can ask if it is unethical to not give music therapy to all included 
patients in the  
nursing homes. However, we are not taking away anything from the 
patients, and all included  
participants will receive pain assessment.  
 
  
 
7. References  
 
 
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