Music therapy embedded in the life of dementia inpatient care
| ISRCTN | ISRCTN86317609 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86317609 |
| IRAS number | 323503 |
| Secondary identifying numbers | CPMS 54739 |
- Submission date
- 02/04/2025
- Registration date
- 25/04/2025
- Last edited
- 25/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Distress is common for people with dementia on hospital mental health wards, but music might help. There are lots of reasons why people get distressed. Sometimes it is a result of symptoms like hallucinations, and sometimes it is because the care they receive does not meet their needs. If a person with dementia is so distressed that they behave in a way that puts themselves or others at risk, they may be admitted to a hospital mental health ward. The aim of the hospital stay is to understand and treat their distress, so that they may be discharged with an appropriate support plan. This can take a long time.
There is little research looking at these hospital wards, which can be very different to general hospital wards or care homes. It is hard to care for someone who is very frightened and distressed, and both staff and patients can get hurt (staff experience more physical assaults than prison officers). Calming medications (antipsychotics) are often given to a person with dementia on these wards when distressed. This is a worry because research suggests that these increase the risks of falls and death.
Music therapy has helped lower distress for people with dementia living in care homes and supported staff to understand why someone might be distressed. But we do not know enough about how music therapy can help people with dementia in mental health wards. Our own research on mental health wards found that on the days the therapy took place, there were fewer assaults and staff could see a positive impact on the ward. But not all mental health wards have music therapy. People with dementia and their family members that we spoke to also found music helpful and supported the idea of having this therapy on wards.
In this 18-month project, we will create a music therapy manual for mental health wards together with people with dementia, their families and staff with the aim of reducing distress and assaults.
Who can participate?
People who have stayed, visited family or worked on mental health dementia in the NHS in the last 5 years can take part in an interview or focus group (Stage 1). Two mental health wards in the NHS will be invited to take part and test the music therapy manual for four weeks (Stage 3). Everybody staying, visiting or working on the wards will be able to take part.
What does the study involve?
The study has three stages:
Stage 1. Talking to people with dementia, relatives and staff with experience of mental health wards. This will help us understand how distress and assaults are currently managed and the support people need.
Stage 2. Co-creating a music therapy manual with people with dementia, relatives and staff based on findings from Stage 1.
Stage 3: Testing the music therapy manual over four weeks on two mental health wards, one that already has music therapy and one that has never offered this before.
Once the manual is finished, we will share it with the public and look to test it on more mental health wards for people with dementia.
What are the possible benefits and risks of participating?
If you take part in this study you can help shape the way that music and music therapy are used on NHS mental health dementia wards. If you are staying, visiting or working on a ward where the intervention is tested you will have access to more music therapy delivered by a qualified healthcare professional. They will help work out how music can best be used to reduce distress and improve care experience for everyone on the ward.
Where is the study run from?
The study is led by Anglia Ruskin University and the Cambridgeshire and Peterborough NHS Foundation Trust (UK). Other supporters include Dementia UK, the University of Cambridge and the University of Hull.
When is the study starting and how long is it expected to run for?
June 2023 to February 2025
Who is funding the study?
National Institute for Health and Care Research, Research for Patient Benefit Scheme (UK)
Who is the main contact?
Naomi Thompson, naomi.thompson@aru.ac.uk
Contact information
Scientific, Principal Investigator
Cambridge Institute for Music Therapy Research
Anglia Ruskin University
Cambridge
CB1 1PT
United Kingdom
| Phone | +44 (0)1223 695401 |
|---|---|
| ming-hung.hsu@aru.ac.uk |
Public, Scientific
Cambridge Institute for Music Therapy Research
Anglia Ruskin University
Cambridge
CB1 1PT
United Kingdom
| Phone | +44 (0)1223 695401 |
|---|---|
| naomi.thompson@aru.ac.uk |
Study information
| Study design | Complex intervention development study including qualitative exploration, co-design of intervention protocol, and a non-randomized feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Prevention, Quality of life, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | MELODIC: co-developing a Music therapy intervention Embedded in the Life Of Dementia Inpatient mental health Care to help manage distress |
| Study acronym | MELODIC |
| Study hypothesis | This is a complex intervention development study with an embedded feasibility study. The aims are: Aim 1: To co-develop a music therapy model (MELODIC) for mental health dementia wards. This will include: 1. A manual outlining music therapy intervention delivery 2. A handbook and resources for ward managers, staff, and relatives Aim 2: To pilot the MELODIC intervention. This will: 1. Enable refinement of the intervention 2. Determine acceptability with patients, relatives, and staff 3. Assess the feasibility of delivery, including facilitators and barriers to implementation 4. Assess adherence to the intervention 5. Establish cost parameters of delivery 6. Test potential outcome measures to inform the design of a future controlled trial |
| Ethics approval(s) |
1. Approved 26/07/2023, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207 104 8283; bradfordleeds.rec@hra.nhs.uk), ref: 23/YH/0155 2. Approved 25/09/2023, Faculty of Arts, Humanity and Social Sciences, Anglia Ruskin University (Anglia Ruskin University, Cambridge, CB1 1PT, United Kingdom; +44 (0)1223 698708; julia.johnson@aru.ac.uk), ref: ETH2223-8044 |
| Condition | Management of distress for people with dementia on NHS mental health wards |
| Intervention | A co-designed, standardised music therapy protocol (MELODIC) will be developed in the first 8 months of the project. This will be tested and refined through a feasibility study on two wards with differing experience of music therapy. Qualitative and quantitative data will be collected to test the feasibility of the research methods. |
| Intervention type | Behavioural |
| Primary outcome measure | The feasibility of intervention delivery and the research methods will be measured by: 1. Intervention adherence measured through interventionist diaries completed during the intervention period, collected post-intervention 2. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 4 months 3. Data completeness for quantitative outcome measures across all four timepoints (4 weeks before, baseline, endpoint, 4 weeks follow-up) 4. Training needs and requirements assessed through interviews conducted post-intervention 5. Costs of intervention delivery calculated post-intervention |
| Secondary outcome measures | 1. Initial impact of MELODIC for patients, staff, families and the ward measured by: 1.1. Realist interviews post-intervention 1.2. Patient standardised questionnaires (4 weeks before, baseline, endpoint, 4 weeks follow-up): 1.2.1. Distress measured by the Neuropsychiatric Inventory and the Cohen-Mansfield Agitation Inventory 1.2.2. Quality of life measured by Quality of Life in Alzheimer’s Disease 1.3. Staff standardised questionnaires (4 weeks before, baseline, endpoint, 4 weeks follow-up): 1.3.1. Job satisfaction measured by Job Satisfaction Index 1.3.2. Burnout measured by the Maslach Burnout Inventory 1.3.3. Attitudes of hope and personhood in dementia measured by the Approaches to Dementia Questionnaire 1.4. Family standardised questionnaires (4 weeks before, baseline, endpoint, 4 weeks follow-up): 1.4.1. Attitudes of hope and personhood in dementia measured by Approaches to Dementia Questionnaire 1.4.2. Mental health measured by the General Health Questionnaire 1.5. Ward level outcomes (4 weeks before, 4 weeks during, 4 weeks after intervention): psychotropic medication use; physical assaults, seclusion, mortality, restraint, staff absence, number of bank/agency staff, patient length of stay, discharge destination 2. Refinement of the MELODIC Music therapy intervention protocol |
| Overall study start date | 01/06/2023 |
| Overall study end date | 01/02/2025 |
Eligibility
| Participant type(s) | Patient, Health professional, Carer |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 150 Years |
| Sex | Both |
| Target number of participants | Qualitative study: 36 participants; feasibility study: 24 patients, 12 family members, 30 staff members |
| Total final enrolment | 138 |
| Participant inclusion criteria | Inclusion criteria for the qualitative study are: 1. Direct or indirect (through family and close friends) experience of inpatient mental health dementia wards in the last five years to capture current experiences 2. The ward was part of the NHS, with private care excluded 3. The ward came under NHS mental health provision, with wards situated within general health hospitals excluded 4. The ward was for people with dementia (sometimes called organic) only, with wards caring for people with other mental health illnesses and dementia together excluded 5. The participant must be able to speak English 6. No geographical restrictions within the UK Inclusion criteria for the feasibility study are: The mental health dementia ward will be purposively sampled. It must meet the above criteria for dementia wards. All patients, staff and families on the ward are eligible to participate. |
| Participant exclusion criteria | Exclusion criteria related to the setting the participant had experience of: 1. Mental health ward not in the NHS 2. Dementia ward within an acute NHS Trust 3. Dementia ward in community nursing or residential care home |
| Recruitment start date | 01/10/2023 |
| Recruitment end date | 01/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Fulbourn Hospital
Fulbourn
Cambridge
CB21 5EF
United Kingdom
Beverley Road
Willerby
Hull
HU10 6FE
United Kingdom
Newbridge Hill
Bath
BA1 3QE
United Kingdom
Greets Green Road
West Bromwich
B70 9PL
United Kingdom
Charles Hastings Way
Worcester
WR5 1JR
United Kingdom
North Shields
NE29 8NH
United Kingdom
Fieldhead Hospital
Ouchthorpe Lane
Wakefield
WF1 3SP
United Kingdom
Cambridge
CB4 2RD
United Kingdom
Sponsor information
University/education
East Road
Cambridge
CB11PT
England
United Kingdom
| Phone | +44 (0)1223 698708 |
|---|---|
| julia.johnson@aru.ac.uk | |
| Website | https://www.aru.ac.uk/ |
"ROR" |
https://ror.org/0009t4v78 |
Hospital/treatment centre
Elizabeth House
Fulbourn
Cambridge
CB21 5EF
England
United Kingdom
| Phone | +44 (0)1223217418 |
|---|---|
| r&d@cpft.nhs.uk | |
| Website | https://www.nhs.uk/services/mental-health-trust/cambridgeshire-and-peterborough-nhs-foundation-trust/RT1 |
|
"ROR" |
https://ror.org/040ch0e11 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Not expected to be made available |
| Publication and dissemination plan | The MELODIC research team has engaged in multiple dissemination activities to share findings with diverse audiences, including researchers, clinicians, policymakers, and the general public. A key event was the public sharing event at Gonville and Caius College, University of Cambridge, on 26 February 2025, co-hosted with Dementia UK. This event brought together stakeholders from healthcare, academia, policy, and the third sector to discuss the role of music therapy in dementia care. Attendees reported increased awareness of music therapy's potential in inpatient settings and the importance of co-design in research. Findings have been shared with professional practitioners and stakeholders through presentations and discussions, including: 1. Consultation meetings with MELODIC study's steering group, interventionists and participants to discuss findings and implications. 2. A presentation to Humber NHS Teaching Foundation Trust, focusing on how staff can continue applying skills learned from the MELODIC project after funding ended. 3. A talk at the Alzheimer's Research UK East Network, where the expert-by-experience co-design lead shared insights on meaningful public involvement in dementia research. The research has also gained widespread media attention, increasing public engagement. A press release on the theory development phase was covered by over 100 media outlets, including The Times, raising awareness of how music therapy can reduce distress in dementia care. Additional media engagements included: 1. An interview on BBC Radio Cambridgeshire, which was shared widely on social media. 2. Features in national and local press, such as the Cambridge Independent, increasing public interest in the research. The study has been presented in academic and clinical settings, including: 3. The Royal College of Psychiatrists Arts Special Interest Group, where professionals expressed interest in further updates. 4. The Inpatient Dementia Community of Practice, where the team discussed implications for a future clinical trial. Plans for Further Dissemination Future dissemination activities will focus on research publications, clinical adoption, and policy engagement. These include: 1. Publishing findings in peer-reviewed journals, including articles on intervention development, pilot study results, and realist process evaluation. 2. Presenting at key conferences, such as the Alzheimer's Europe conference 2025, Alzheimer's Disease International Conference 2026 and the World Congress of Music Therapy 2026. 3. Developing training resources to support NHS staff in implementing the intervention. 4. Collaborating with policymakers and healthcare leaders to explore integrating music therapy into national dementia care strategies. |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not publicly available due to their confidential nature, but are available from the corresponding author on reasonable request (cimtr@aru.ac.uk). The type of data that will be shared: anonymised data. Individual demographic information will not be shared to protect anonymity due to the small dataset. Information on type of participant (staff/patient/family member) will be provided. Dates of availability: until February 2035. Whether consent from participants was required and obtained: participant consent for sharing of anonymous data for secondary analysis required and obtained. Comments on data anonymization: ID numbers will be assigned to all participants. Any ethical or legal restrictions: ethical approval has been obtained from the Health Research Authority and Anglia Ruskin University. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 18/12/2024 | 03/04/2025 | Yes | No |
Editorial Notes
02/04/2025: Study's existence confirmed by the NIHR.
