The effects of individual music therapy in nursing home residents with dementia to improve general well-being: study protocol of a randomized controlled trial

doi:10.21203/rs.3.rs-2357458/v1

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Study protocol

The effects of individual music therapy in nursing home residents with dementia to improve general well-being: study protocol of a randomized controlled trial

https://doi.org/10.21203/rs.3.rs-2357458/v1

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published 27 Mar, 2024

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Background: Dementia is often associated with Neuropsychiatric Symptoms (NPS) such as agitation, depression, hallucinations, anxiety, that can cause distress for the resident with dementia in long-term care settings and can impose emotional burden on the environment. NPS are often treated with psychotropic drugs, which, however, frequently cause side effects. Alternatively, non-pharmacological treatments approaches can improve well-being and maintain an optimal quality of life (QoL) of those living with dementia. Other outcomes associated to QoL, such as pain, discomfort and sleep disruption are relevant outcomes in trials as well. Music therapy is a non-pharmacological treatment that can reduce NPS and improve wellbeing, and its associated symptoms in dementia.

Methods: The research is conducted at eight facilities of one nursing home organization in the Netherlands. The participants in the intervention group receive 30 minutes of individual music therapy (MT) in their own room by a music therapist twice a week for 12 weeks. The participants in the control group receive 30 minutes of individual attention in their own room by a volunteer twice a week for 12 weeks. Assessments will be done at baseline, 6 weeks and 12 weeks. An independent observer, blinded for the intervention or control condition, assesses directly observed wellbeing (primary outcome) and pain before and after the sessions. Nurses assess other secondary outcomes unblinded, i.e., perceived quality of life and NPS assessed with validated scales. The sleepy duration will be indirectly assessed by a wrist device called MotionWatch. Information about psychotropic drug use is derived from electronic medical chart review.

Discussion: The main purpose of this study is to assess the effects of individual music therapy on directly observed wellbeing controlled for individual attention in nursing home residents with dementia with NPS. The outcomes refer to both short-term and long-term effects consistent with therapeutic goals of care for a longer term. We hope to overcome limitations of previous study designs such as not blinded designs and music facilitators that were not only music therapists but also occupational therapists and nurses. This study should lead to more focused recommendations for practice and further research into non-pharmacological interventions in dementia.

Trial registration: The trial is registered at the International Clinical Trials Registry Platform (ICTRP) search portal in the Netherlands Trial Registration number NL7708, registration date 04-05-2019.

Dementia

quality of life

psychosocial intervention

music therapy

behavioral symptoms

randomized controlled trial

nursing homes

neuropsychiatric symptoms.

Dementia is a common disease and in 2021, the World Health Organization estimated that around 55 million people have dementia worldwide. Every year, there are nearly 10 million new cases [1]. Dementia is a neurodegenerative syndrome characterized by a progressive deterioration of cognitive function, in particular memory but other cognitive domains such as language, praxis, visual perception and most notably executive functions are also often affected [2]. Personality and behavior changes, together with a decline in the ability to perform activities of daily living, may result in a loss of independence. The personality and behavioral changes are often reflected in neuropsychiatric symptoms. More specifically, neuropsychiatric symptoms may express itself in, for example, agitation, disinhibition, irritability, delusions, hallucinations, depression, anxiety and apathy. These symptoms are ubiquitous in nursing home patients with dementia, with overall rates of more than 80% [3].

As there are no curative treatments for the dementias yet, it is important to focus on interventions that may have beneficial effects on well-being and maintain an optimal quality of life of those presently living with the condition. Quality of life is defined by the WHO as “individuals' perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns” [4]. Well-being is defined in terms of a state of equilibrium existing between personal resources and life challenges that, when achieved, gives rise to positive emotions and psychological health [5]. The constructs of QoL and well-being have often been used inter-changeably in dementia research [6].

There is a growing consensus that quality of life is an important outcome for assessing the effectiveness of interventions for dementia in clinical trials even though it concerns a multidimensional construct influenced by a variety of factors [7,8]. Several determinants of quality of life have been described in the literature, such as neuropsychiatric symptoms, cognition and psychotropic drug use [9]. One cause of neuropsychiatric symptoms can be pain that can also have a direct influence on quality of life [10]. In nursing home residents, the prevalence of pain ranges from 30 to 70% [11,12,13]. Pain may have a negative effect on behaviour and mood; the latter reflected in depression. It has been observed that pain may express itself in agitation, aggression, or withdrawal. Pieper et al. [14] with available evidence suggest that (pain) interventions targeting behaviour, and (behavioral) interventions targeting pain are effective in reducing pain and behavioral symptoms in dementia. Further, pain may be expressed through vocalizations (e.g., crying, screaming, noisy breathing) and specific facial expressions (e.g. grimacing) [10]. Another factor that may reduce QoL of people with dementia is a deterioration of sleep quality. Petrovsky et al. used domains of Lawton’s framework for quality of life in persons with dementia to synthesize current knowledge on the association between sleep disruption and quality of life in persons with dementia. Sleep disturbances include poor sleep efficiency and increased night awakenings. Sleep disruption was negatively associated with all of four QoL domains (physical functioning, social/behavioral functioning, emotional well-being and cognitive function). In sum, neuropsychiatric symptoms, in relation to or provoked by pain and sleep disturbances, reduces QoL in people with dementia [15].

Consequently, the question arises if adequate strategies are available for treating this triad of symptoms, i.e. neuropsychiatric symptoms, pain, and sleep disturbances, and hence, improving QoL, in people with dementia. Neuropsychiatric symptoms are often treated pharmacologically with psychotropic drugs, which frequently cause unwanted side effects, such as somnolence and extrapyramidal symptoms [16]. Neuropsychiatric symptoms and psychotropic drug use appear to be independently associated with impaired QoL in patients in moderate and advanced stages of dementia [9]. Alternatively, there is ample evidence that nonpharmacological therapies like psychosocial interventions may lead to a substantial reduction of antipsychotic drug prescriptions [17]. Nonpharmacological therapies such as validation, reminiscence, psychomotor therapy, multisensory stimulation and music therapy can increase QoL of people with dementia and their caregivers [18]. Non-pharmacologic treatments have the potential to improve meaningful outcomes for older people at risk of, or living with dementia according to, for example, an extensive review by Sikkes et al. in 2020. They conclude that the evidence strongly supports various non-pharmacologic treatments in relation to their primary targets such as cognition or behavior.[19].

With respect to the latter, music therapy is a non-pharmacological intervention which is used as a treatment for neuropsychiatric symptoms in patients with dementia [19, 20, 21, 22]. In the USA, music therapy is defined by the American Music Therapy Association (AMTA) as “the clinical and evidence-based use of music interventions within a therapeutic relationship to accomplish individualized goals by a credentialed professional who has completed an approved music therapy program” [23]. This definition of music therapy and the accompanying AMTA Standards of Practice recommend an individualized treatment process, including referral, building a therapeutic relationship, assessment, observation, targeting individualized goals and objectives, treatment planning, protocol selection and implementation, termination and evaluation [24]. A large cluster-randomized controlled trial research of music interventions for dementia and depression in nursing home residents described that group music therapy and recreational choir singing combines biological, psychological, cognitive, social and emotional mechanisms. These mechanisms may reduce aggression, depression and improve cognitive ability, and in addition, reduced medication use and burden on staff. [25].

The number of studies examining the effects of music therapy for people with dementia has increased over time. A Cochrane review in 2011 [26] included 10 studies mostly of poor quality and could not draw firm conclusions about the effects of music therapy (individual or group therapy) in the treatment of behavioral, social, cognitive and emotional problems of older people with dementia. In a recent Cochrane review [27]twenty-two studies were included. The review concluded that providing people with dementia who are in institutional care with at least five sessions of a music-based therapeutic intervention reduces neuropsychiatric symptoms. It may also improve emotional well-being and quality of life. However not all outcomes were assessed blinded. The Cochrane review found that individual therapy, compared with group therapy, had larger effects on behavioral outcomes (agitation, aggression and overall behavioral problems).

In Alzheimer’s disease and different types of dementia, musical memory is surprisingly well preserved [28,29]. The relative preserved memory for music in dementia, might facilitate communication in those who are less able to express themselves verbally [30]. Music therapy is one of the few therapeutic approaches that can be offered via individual treatment, as well as through a group approach [31]. Group approach benefit the engagement and social interaction but in advanced stages of dementia individual music therapy can better reach the residents with communicative limitation. In a trials review between 2000 and 2011 [20] on the use of music and music therapy in dementia, it was concluded that personalized interventions with music or music therapy may be a predictor of success. Throughout neurodegenerative loss, such as in case of Alzheimer’s or Parkinson’s diseases, music therapy may accompany the individual from early diagnosis into the final stages of these and other similar conditions.

In 2010, we conducted a randomized pilot study using individual music therapy in a nursing home in the Netherlands. In this pilot the participants of the intervention group received individual music therapy from a qualified music therapist that used a person-centered approach. The results pointed to possible reduction of neuropsychiatric symptoms in patients who received individual music therapy compared to patients in the control condition who received usual care [32]. In this pilot study, the sample size was very small and the outcome assessments were not blinded. Sakamoto et al. [33] conducted an RCT in 2013 with blinded outcome assessment and individual intervention sessions carried out by music facilitators. The study indicated that interactive individualized interventions reduce stress and increase relaxation in individuals with severe dementia immediately after the intervention.
The main purpose of the study is to build on the earlier pilot study with an improved design, in which we blindly assess the effects of individual music therapy on directly observed well-being and other outcomes controlled for individual attention in nursing home residents with dementia who also have neuropsychiatric symptoms.

Trial design

The design involves an individual randomized controlled trial (RCT) employing longitudinal repeated measurements in nursing home residents with dementia and NPS. The study is single blinded. The research assistant who assesses the primary outcome wellbeing and the secondary outcome pain through observation does not know whether residents participate in the experimental group or the control group. The music therapist and the patients themselves cannot be blinded to the condition they are assigned to. Nursing staff that performs the measurements as part of the secondary outcomes is not blinded either. The research takes place at eight facilities of a nursing home organization where music therapy is applied in 30-minutes sessions, twice a week for 12 weeks, in their own room. The control group receives a ‘social’ visit with individual attention with the same frequency and of the same duration.

A process evaluation is performed according to an approach developed by Saunders et al. [34], using components from Linnan and Steckler's [35]. The process evaluation is based on mixed methods, collecting quantitative and qualitative data. Qualitative data collection comprises a focus group discussion with participants of health care professionals to evaluate barriers and facilitators influencing the implementation of research protocol. Quantitative data is gathered with questionnaires about reach, dose delivered, dose received, fidelity, recruitment and participant engagement. Quantitative data is gathered with questionnaires at 1, 2, 6 and 12 weeks after the intervention starts for the participant with questionnaires completed by music therapists (intervention) or attendants (control). The questionnaires include items about participation in the sessions, fidelity, dose, engagement and about process levels of implementation. Nurses and a research assistant will fill a questionnaire at the end of treatment to evaluate the process of implementation. Quantitative data will be analyzed with descriptive statistics.

Participants’ eligibility

Inclusion criteria

First, candidate participants residing on a psychogeriatric unit are screened for eligibility according to the following criteria:

Candidate has a charted diagnosis of dementia, which is usually according to Diagnostic and Statistical Manual of Mental Disorders IV criteria (American psychiatric association, 2001).
Display a clinically relevant NPS measured with the Neuropsychiatric Inventory Nursing Home Version (NPI-NH) [36,37] with the Frequency X Severity item score for at least one individual item rated 4 (Wood, 2000 [38]; Margallo et al., 2001 [39], Zuidema et al., 2007 [3], Zuidema et al., 2010 [40]).

Exclusion criteria:

Candidate having received individual music therapy before or having participated in a music therapy group in the past 3 months.
Candidate has major comorbid psychiatric diagnosis (i.e., schizophrenia, psychosis, anxiety disorder). Due to an overlap between depression and dementia [41], candidate participants with a history of depression will not be excluded.
Candidate has a hearing impairment that hampers the listening to music at a moderately volume. We use item 1a of the Severe Dual Sensory Loss in old age screening tool (SDSL) [42]. SDSL was found a valid and reliable tool [43].

Recruitment

For eligible residents, medical staff (physicians) of the nursing home facilities of Amstelring will select the participants. The researcher provides an information letter with informed consent form to competent candidate participants and to legal representatives of non-competent candidate participants. After informed consent or proxy informed consent has been given and the participant has been recruited, the participants are randomly allocated to the intervention group (individual music therapy) or control group (individual attention). Randomization is performed by a statistician who is not involved in carrying out the study in the facilities, using randomization software.

Intervention

The participants of the intervention group (music therapy) receive 30 minutes of individual music therapy twice a week for 12 weeks in their own room. Music therapists use music experiences to promote health [44]. In this trial, music therapy consists of individual active music therapy sessions with also receptive techniques. Individual music therapy implies a one-to-one contact between the music therapist and the patient using a person-centered approach. Receptive and active music therapy are often combined [45]. Receptive therapeutic interventions consist of listening to music by the therapist who sings, plays or selects recorded music for the recipients. In active music therapy, recipients are actively involved in the music-making, for instance by playing on small instruments. The participants may be encouraged to participate in musical improvisation with instruments or voices, movements activities or singing.

To determine the precise content of the intervention and to standardize procedures amongst all music therapists, a focus group with 7 music therapists working at the nursing home facility Amstelring was conducted. The focus group established a therapy protocol that comprised six steps for this study purpose:

All participating music therapists are employed by the nursing home organization. The music therapists are qualified and credentialed professionals by the federations for music therapy in the Netherlands (NVvMT), indicating that they have all been trained at an acknowledged and certified music therapy study program.
The music therapist will ask, before the start, the participant or a legal representative about the musical preferences of the participant with a questionnaire (Gerdner, 2010 [46], Raven-de Vries, 2018 [47]). Based on this information, the music therapist will develop an individual music therapy session for the participants.
Music therapists start every session trying to connect with the patient with eye contact, calling the name or giving a hand, to build trust.
Music therapists use an observation list between 4 and 6 weeks. This observation list is based on the improvisational music therapy guideline of Kurstjens [48] and has been used to identify which important musical elements are of help in the approach of the problem.
The music therapists will adapt the therapy continuously to needs and wishes of the participants. Participants receive an individual session tailored to the musical preferences of the participant.
The participant will be invited to make a choice out of different musical instruments such as a guitar, keyboard, drums, maracas, etc. The therapist will aim at using active techniques mainly, for example improvisation where participants will try to play the instruments, sing together, clap the hands, move the body or face with the music. Also, receptive techniques will be used such as listening to live or pre-recorded music. The music therapist provides a safe environment, in which the participant can experience contact, interaction, atonement, structure and a natural finishing of the session.

The music therapists will make a written report of each session. In case of adverse reactions, music therapists will inform the researcher (VBC). The music therapy will then stop immediately.

Control condition

The control group receives 30 minutes of individual attention twice a week for 12 weeks with no therapeutic basis. Individual attention will take place through a social visit, during which an attendant will drink coffee or tea with the participant. The individual attention will be given in the resident's room by one attendant, who will have a conversation with the participant, drink coffee without a therapeutic goal such as cognitive training and without any musical intervention. The person who is doing the social visits is an informal care support company employee or volunteer. This is on top of the regular usual care delivered. The attendant starts every session by trying to connect with the patient via eye contact, calling his/her name or giving a hand, to build trust.

The attendants from the informal care support company or care support volunteer who provide the individual attention report attended sessions in the participants forms.

During the Covid-19 outbreak, the music therapists (intervention group) and the attendants (control group) use gloves and mouth masks through the sessions.

Primary outcome measure

Observed well-being is the primary outcome measure. Lawton has most extensively explored the concept of QoL concerning dementia and described QoL in dementia in terms of four sectors: psychological well-being, behavioral competence, objective environment (response to surroundings) and perceived QoL [49,50,51]. Jonker et al. review conceptual developments in QoL research concerning dementia and based on the dimensions presented by Lawton, they identified psychological well-being as the core dimension of QoL of patients with dementia [52]. We chose to use an instrument also applicable in persons with advanced dementia that receiving residential care to evaluate well-being. Well-being is assessed with an observational instrument-the Discomfort Scale - Dementia of Alzheimer Type (DS-DAT) where discomfort is defined as a negative emotional and/or physical state subject to variation in magnitude in response to internal or environmental conditions. It is a measuring scale for direct observation of behavior of a patient and is applicable also in later phases of dementia [53]. The Dutch translation is characterized by a good reliability (Hoogendoorn et al. 2001) [54] and validity (van der Steen et al. 2002) [55,56]. The scale consists of 9 items measuring 7 negative and 2 positive items regarding vocalization, breathing, facial expression, and body movements. The nine 4-point items are summed for a total score ranging from 0 (no observed discomfort) to 27 (highest possible level of observed discomfort). Well-being will be assessed by a blinded research assistant at baseline (T0), six weeks (T1) and twelve weeks (T2). Well-being is assessed during 5 minutes before and after the music therapy sessions or individual attention sessions. The research assistant will be trained in using the DS-DAT trough an instructional video and practice completion of the DS-DAT with videotaped patients. Feedback is provided against the scores of the scale's developer (Dr Hurley) who had rated the patient video clips.

Secondary outcomes measures
Secondary outcomes are also assessed in all /participating residents and include pain, quality of life, neuropsychiatric symptoms (agitation, anxiety, symptoms of depression), quality of sleep and psychotropic drug use.

Pain will be assessed by a blinded research assistant at baseline, six weeks and twelve weeks during 2 minutes before and after the intervention session or individual attention with the PAIC-15 (Pain Assessment in Impaired Cognition) [57,58] which is an observational assessment instrument that lists 15 items and uses scores from 0 to 3 for each item. PAIC-15 comprises three domains: facial expression, body movements and verbalizations/vocalizations. Each domain has 5 items and the total score is the sum of all items, ranging from 0 to 45. The research assistant will be trained in using the PAIC-15.

Quality of life will be rated by non-blinded nurses at baseline (T0), at six weeks (T1) and at twelve weeks (T2) with the Quality of Life in Late-Stage Dementia Scale (QUALID) [59] that can be used with late-stage dementia patients in institutional settings and has been designed for proxy-rating by nurses. Responses reflect patient behavior over the past seven days. The QUALID consists of eleven items that are short and simple and is characterized by a good reliability and validity and the Dutch translation was a valid measure for quality of life in patients with advanced dementia [60]. The total score is the sum of all items, ranging from 11 to 55. Lower scores indicate a higher quality of life.

Neuropsychiatric symptoms will be assessed by non-blinded nurses at baseline (T0), at six weeks (T1) and at twelve weeks (T2) with the Neuropsychiatric Inventory Nursing Home Version (NPI-NH), a scale originally developed by Cummmings [61,62] to assess neuropsychiatric symptoms in outpatients with dementia. The nursing home version was developed for use of professional caregivers in institutions and proved to be valid and reliable for trained nursing staff [63,64]. The NPI-NH is the only nursing home instrument to assess neuropsychiatric symptoms that occurred in the past four weeks that has been translated into Dutch [65]. The NPI is a structured interview that includes 12 neuropsychiatric symptoms: delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behavior, night-time disturbances and appetite/eating change. Frequency (F) and severity (S) of each symptom are rated on a four (1-4) and three (1-3) point scale respectively. A separate score can be calculated for each symptom by multiplying the frequency and severity (FxS score), resulting values range from zero to 12 for each symptom. Summing all FxS scores results in a total score that ranges from 0 to 144. Interview also includes a caregiver distress questions using a 5-point scale

Agitation and aggression will be assessed by non-blinded nurses at baseline (T0), 6 weeks (T1) and 12 weeks (T2) using the caregiver rated questionnaire Cohen-Mansfield Agitation Inventory (CMAI). This instrument, developed by Cohen-Mansfield and Billig [66] and validated by Miller et al. [67] is an instrument that specifically addresses agitation or aggression that has been translated into Dutch. The Dutch translation of the CMAI (CMAI-D) has been validated by the Jonghe [68] and rated agitated behaviors occurred during last twee weeks. The frequency of each symptom is rated on a seven-point scale (1-7) ranging from 'never' to 'several times an hour'. Summing all symptom scores results in a total score that ranges from 29 to 203.

Symptoms of depression will be rated by non-blinded nurses at baseline (T0), at six weeks (T1) and twelve weeks (T2) with the Cornell Scale for Depression in Dementia (CSDD) [69], which has good internal consistency [70]. Responses reflect symptoms of depression in the week before. The CSDD is a 19-item instrument, with scores for each item ranging from 0 to 2 (total score range 0-38). The CSDD has been translated into Dutch [71].

Rest-activity data will be collected by a MotionWatch (CamNtech Ltd, Cambridge, UK). The MotionWatch measures the arm movements of the participant; based on these movements, the rest-activity and physical activity are determined. It quantifies accelerations due to motor activity of the arm and integrates these over I-minute periods. The MotionWatch has the size and shape of a watch, is worn on the dominant wrist. The participants will be asked to wear the MotionWatch twenty-four hours a day for 1 week in the week before the intervention starts (T0) and the week directly after the last intervention session (T2). Nurses are asked to temporarily take off the MotionWatch when the participant takes a shower, performs another activity in which the MotionWatch could be exposed to too much water. Nurses will report the time that devices are taken off. Five parameters will be calculated: Interdaily stability, Intradaily variability, Relative Amplitude, most active period of 10 hours and least active period of five hours.

Data on chronic and pro re nata (as needed) psychotropic drug use will be derived from the electronic medical chart. Psychotropic drugs will be categorized into antipsychotics, anxiolytics, hypnotics, antidepressants and anti-dementia drugs according to the Anatomical Therapeutic Classification (ATC) system.

Any attrition or adverse effects of the interventions will be documented. The interventions will be discontinued if, in consultation with the physician or psychologists, harmful effects are observed and are expected to continue with exposure to any of the two interventions.

Procedure

All eligible residents for whom consent have been provided will be randomly allocated to the intervention group (individual music therapy) or control group (individual attention). Randomization will take place with a statistician using randomization software. The outcomes variables are measured at baseline (T0) one week before individual attention of music therapy starts (pre-treatment), after 6 weeks of intervention (T1) and after 12 weeks of intervention (T2). Figure 1 shows the participants flow.

Measurements (DS-DAT and PAIC-15) will be done just shortly before (T1a and T2a) and shortly after the intervention (T1b and T2b); to assess overall effects, cumulative and immediate effects (see table 1). The study is single blinded meaning that the therapist and the patients themselves are not blinded. Trained research assistants are blinded to intervention assignment, conduct the well-being and pain measurements. Data prescription records concerning medication use, among which psychotropic drugs, will be extracted from the electronic medical charts by VBC, physician employed by the participating organization. The nursing staff will complete the scales concerning the various stages of dementia, QoL, NPS, agitation and symptoms of depression. Blinding to these measurements is not possible because these measurements require familiarity with the person's usual behavior after a one or two-week period of observations. The nursing staff that complete the questionnaires are not blinded but they are not informed about the hypothesis and specific research questions.

Demographic variables (age and gender) will be assessed at baseline from the electronical medical chart review. The nurses will determine the stage of dementia, measured with the Global Deterioration Scale [72,73]. The Global Deterioration scale (GDS) describes seven stages: 'no global impairment' (1), 'very mild cognitive decline' (2), 'mild cognitive decline' (3), 'moderate cognitive decline' (4), 'moderately severe' (5), 'severe' (6) and 'very severe global impairment' (7).

Table 1: Instruments at different assessment moments

Outcomes/instruments	T0	T1a (pre-treatment)	T1b (post-treatment)	T2a (pre-treatment)	T2b (post-treatment)
Primary outcome
Well-being (DS-DAT)	X	X	X	X	X
Secondary outcomes
Pain (PAIC-15)	X	X	X	X	X
Quality of life (QUALID)	X		X		X
Neuropsychiatric symptoms (NPI-NH)	X		X		X
Agitation (CMAI)	X		X		X
Depressive symptoms (CSDD)	X		X		X
Stages of dementia (GDS)	X
Rest/activity (Actigraphy)	X				X
Medication use (ATC classification)	X				X

DS-DAT: Discomfort Scale - Dementia of Alzheimer Type, PAIC-15: Pain Assessment in Impaired Cognition, QUALID: Quality of Life in Late-Stage Dementia Scale, NPI-NH: Neuropsychiatric Inventory Nursing Home Version, CMAI: Cohen-Mansfield Agitation Inventory, CSDD: Cornell Scale for Depression in Dementia, GDS: Global Deterioration scale, ATC: Anatomical Therapeutic Classification system.

At baseline, nurses will register whether the resident has any background in music with questions about their experiences with music before entering the nursing home. The relatives of participants are asked closed-ended questions if the participant:

(1) Has no experience with music in the past

(2) Played an instrument before or was involved in singing activities or made music in some other way

(3) Has served as a professional musician

Sample size

The sample size is based on the study’s primary outcome measure, the Discomfort Scale - Dementia of Alzheimer type (DS-DAT) [54]. To determine the sample size required to assess relevant effects, we used the data from the Cochrane review [27]. We used the effect on emotional wellbeing and quality of life (SMD 0.32, 95%CI 0.02 to 0.62). The correlation between multiple assessments of the DS-DAT was calculated with the data of Schalkwijk et al. [60] as 0.6. Using a type I error of 0.05, a power of 0.80, two follow-up measurements and 2 groups, a sample size of 30 in each group is required, totaling 60 participants. It is estimated that about a quarter (20 of 80 residents) may die or will be lost to follow up for other reasons during the study period, so we need to enroll a total of around 80 residents for this study.

Data analysis

Immediate effects are defined as the difference in change between outcomes 15 minutes before and after the intervention sessions. Cumulative effects are effects over time not including those immediately after the session (i.e., built-up effect over time and measured before the session in order not to include possible immediate effects of the session). Overall effects are effects over time including those immediately after the session. Immediate, cumulative and overall effects are analyzed with mixed model analysis to consider the dependency of the repeated observations within the patient.

For the immediate effects, the outcome will be the post-test (T1b, T2b) and adjustment will be made for the pre-test (T1a, T2a). For the cumulative effect, the outcome will be the pre-test and an adjustment will be made for the baseline. For overall effects, the outcome will be post-test and adjustment will be made for the baseline.

For all treatment effects, effects at the different time-points will be analyzed by adding a time x treatment interaction to the mixed model analysis. Furthermore, both crude and adjusted (adjustments for gender, age, cognitive deterioration and for medication use, which will be added as a time-dependent covariate) will be performed. In the mixed model analysis, we will also evaluate whether an adjustment for the correlated observations within facilities is necessary.

There is no need to impute missing data because mixed models can handle missing assessments. In explorative post-hoc analysis we will evaluate whether the intervention effects will be different for patients with a musical background by adding the interaction between the intervention variable and presence of musical background.

For the secondary outcomes which will be measured five times (i.e., pain) the same analyses will be used as for the primary outcome. The secondary outcomes that are measured three times (i.e., quality of life, NPS, agitation, anxiety, and symptoms of depression) will be analyzed with ordinary least squares regression (OLS). OLS can be used because the outcomes are repeatedly measured.

Sleep quality data of the MotionWatch (CamNtech Ltd, Cambridge, UK) will be analyzed with Motionware software version 1.2.1. Five parameters will be calculated: Interdaily stability, Intradaily variability, Relative Amplitude, most active period of 10 hours and least active period of five hours. First, the interdaily stability variable that quantifies the strength of coupling between the rest-activity rhythm and supposedly stable Zeitgebers (e.g., meals) is calculated. The second variable is the intradaily variability, which quantifies the fragmentation of the rhythm, that is, the frequency and extent of transitions between rest and activity. The third variable is the relative amplitude and quantifies the difference between the main activity (day) and rest (night) periods. The parameter of 10 most active hours (M10) is used to determine the amount of physical activity. The parameter (L5) are least active periods of five hours to determine rest activity. The 5 parameters will be analyzed with linear regression analyses with the values measured after the intervention period as outcome with an adjustment for the baseline vale of particular outcome.

Study monitoring

This clinical trial does not involve a high-risk intervention. We do not expect adverse events or significant unintended effects of the intervention. However, the participants of this study are vulnerable subjects and monitoring and quality assurance will be necessary according to national legislation (WMO). The Department of anesthesiology (an independent department of UMCG) will be responsible for the data monitoring.

Quality of life (QoL) is a multi-dimensional concept that includes well-being and has objective and subjective effects [49,50, 51]. Psychological well-being is considered to be the central indicator for QoL of patients with dementia [52]. This study aims to show if individual music therapy leads to improved well-being of nursing home residents with dementia and neuropsychiatric symptoms. Well-being and quality of life in dementia are important to patients and families. NPS result in a lower QoL for people with dementia and their caregivers and affect the quality of the relationship with the caregivers [74]. Efforts aiming at preventing low or decreasing QoL at any stage of dementia should, therefore, target the factors associated with lower QoL such as psychotropic drug use [17], NPS [9], pain [10] and sleepy disturbances [15] as well as keeping a person-centered approach open to the individual perceptions of QoL [75].

Further, in patients unable to self-report, directly observed wellbeing is an expression of their emotional and physical state and an important indicator of comfort and quality of life, in addition to impressions of quality of life assessed over a specific time window such as the previous week. Quality of life is an important outcome of different care approaches, including palliative care. Improving quality of life and maximizing comfort are goals of palliative care in dementia [76]. With this design and specific analyses, we can ensure blinding and allow estimation of short and long-term effects.

Participants receive either individual music therapy or a social visit for individual attention, in their own room. This is because the room represents a safe place for the resident (moving to another room may lead to more restless behavior unnecessarily during the already short duration of the therapy session.

Research often lacks methodological rigor and continues to produce mixed results. The 2018 Cochrane review [27] showed modest positive effects in meta-analyses of 9 studies on emotional well-being and quality of life of interventions that included both group and individual interventions. Only seven studies had offered individual music therapy treatment. Sensitivity analyses indicated that the SMDs for individual therapy were similar to those for the main analyses with individual and group therapy, except for behavioral problems (both agitation or aggression and overall), for which SMDs for individual therapy were clearly larger. In this Cochrane review, many studies did not used blinded outcome assessment. We use blinded assessment for primary outcomes but possible limitations of this study will be the unblinded assessment of secondary outcomes (with the QUALID, NPI-NH, CMAI, CSDD) assessed by nurses of the department.

During the Covid-19 outbreak, the music therapists (intervention group) and the attendants (control group) will use gloves and mouth masks through the sessions that may complicate the relation between participants and music therapists or attendants. Residents who participate in the study during Covid-19 period might receive substandard quality sessions because of the difficulties in the verbal and non-verbal contact. Sensitivity analysis will be done to examine whether this period with wearing of masks and gloves yields a negative effect on treatment outcome, compared to the period before (or after) the outbreak of COVID-19.

The present study aims to make a next step in the field of music therapy and address the limitations of earlier research by including a larger number of participants and investigating if individual music therapy has an effect on well-being of people with dementia and on NPS and other outcomes. Major strengths of the current study design are, first, the blinded primary outcome assessments and second, the comparison between intervention group with the control group receiving enhanced usual care to rule out effects of extra individual attention. The participants of the intervention group will receive individual music therapy from qualified and certified music therapists with knowledge and skills that are clinically relevant to personalized care delivery. This study will help to clarify the effects of individual music therapy in dementia care.

NPS: Neuropsychiatric symptoms; MT: Music therapy; AMTA: American Music Therapy Association; NVvMT: Dutch association of music therapists: DS-DAT: Discomfort Scale - Dementia of Alzheimer Type; PAIC-15: Pain Assessment in Impaired Cognition; QUALID: Quality of Life in Late-Stage Dementia Scale; NPI-NH: Neuropsychiatric Inventory Nursing Home Version; CMAI: Cohen-Mansfield Agitation Inventory; CSDD: Cornell Scale for Depression in Dementia; GDS: Global Deterioration scale; WMO: medical research involving human subjects act

Funding:

Amstelring Care Institution (RVB U-9109-2019 IB/RR/lw) support this study. This study has also Alzheimer Nederland as subsiding party (Project number: WE.09-2018-06). The funders had no role in the study design, data collection and analysis of data.

Ethics approval and consent to participate

This study was conducted according to the guidelines laid down in the declaration of Helsinki. Ethical approval was obtained from the Medical Ethics Review Board of the university medical center of Groningen (UMCG) in the context of the Medical Research Involving Human Subjects Act (WMO). The review board reference number is METc 2019/021. An informed (proxy) consent is obtained for all participants. Participation in the study will be voluntary. Participants or legal representatives can withdraw consent at any time. Any attrition or adverse effects of the intervention or control group will be documented. In addition to sessions immediately stopped in the case of adverse reactions, the interventions will be discontinued if, in consultation with the physician or psychologists, harmful effects are observed and are expected to continue with exposure to any of the two interventions.

Competing interests

The authors declare that they have no competing interests.

Access to data

The anonymized data that support the findings of this study are available upon reasonable request from the corresponding author. The data are not publicity available due to privacy or ethical restrictions.

Acknowledgments:

The authors want to acknowledge the nursing home residents who voluntarily participated in this study. We thank all the music therapists and nurses of Amstelring who contributed to this study. We thank the research assistant Marianne Pruis who did all the blinded observations.

Authors’ contributionsand consent for publication

All authors made substantial contributions to conception and design and were involved in drafting the manuscript or revising it critically for important intellectual content. All authors read and approved the manuscript for publication.

Authors orcid id authors:

Vanusa M. Baroni Caramel: 0000-0002-1921-0951

Jenny T. van der Steen^:0000-0002-9063-7501

Annemieke C. Vink: 0000-0003-4242-4314

Sarah I.M. Janus: 0000-0003-0419-4407

Jos W.R Twisk: 0000-0001-9617-1020

Erik J.A. Scherder: 0000-0003-1203-3208

Sytse U. Zuidema: 0000-0002-4991-9507

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No competing interests reported.

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The effects of individual music therapy in nursing home residents with dementia to improve general well-being: study protocol of a randomized controlled trial

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