Music therapy embedded in the life of dementia inpatient care

ISRCTN	ISRCTN86317609
DOI	https://doi.org/10.1186/ISRCTN86317609
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	323503
Protocol serial number	CPMS 54739
Sponsors	Anglia Ruskin University, Cambridgeshire and Peterborough NHS Foundation Trust
Funder	Research for Patient Benefit Programme

Submission date: 02/04/2025
Registration date: 25/04/2025
Last edited: 17/07/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Dr Ming-Hung Hsu
Scientific, Principal investigator

Cambridge Institute for Music Therapy Research
Anglia Ruskin University
Cambridge
CB1 1PT
United Kingdom

Phone	+44 (0)1223 695401
Email	ming-hung.hsu@aru.ac.uk

Mrs Naomi Thompson
Public, Scientific

Cambridge Institute for Music Therapy Research
Anglia Ruskin University
Cambridge
CB1 1PT
United Kingdom

Phone	+44 (0)1223 695401
Email	naomi.thompson@aru.ac.uk

Study information

Primary study design	Interventional
Study design	Complex intervention development study including qualitative exploration, co-design of intervention protocol, and a non-randomized feasibility study
Secondary study design	Non randomised study
Study type	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 objectives	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
Health condition(s) or problem(s) studied	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(s)	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
Key secondary outcome measure(s)	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
Completion 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	All
Target sample size at registration	102
Total final enrolment	138
Key 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.
Key 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
Date of first enrolment	01/10/2023
Date of final enrolment	01/12/2024

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Cambridgeshire and Peterborough NHS Foundation Trust

Elizabeth House
Fulbourn Hospital
Fulbourn
Cambridge
CB21 5EF
United Kingdom

Humber Teaching NHS Foundation Trust

Trust Hq, Block A, Willerby Hill
Beverley Road
Willerby
Hull
HU10 6FE
United Kingdom

Avon and Wiltshire Mental Health Partnership NHS Trust

Bath NHS House
Newbridge Hill
Bath
BA1 3QE
United Kingdom

Black Country Healthcare NHS Foundation Trust Hq

Delta Point
Greets Green Road
West Bromwich
B70 9PL
United Kingdom

Herefordshire and Worcestershire Health and Care NHS Trust

Unit 2 Kings Court
Charles Hastings Way
Worcester
WR5 1JR
United Kingdom

Northumbria Healthcare NHS Foundation Trust (headquarters)

Rake Lane
North Shields
NE29 8NH
United Kingdom

South West Yorkshire Partnership NHS Foundation Trust

Trust Headquarters
Fieldhead Hospital
Ouchthorpe Lane
Wakefield
WF1 3SP
United Kingdom

Woodlands Care Centre

Hawkins Road
Cambridge
CB4 2RD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request, Not expected to be made available
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?
Results article		02/05/2025	17/07/2025	Yes	No
Results article		16/07/2025	17/07/2025	Yes	No
Protocol article		18/12/2024	03/04/2025	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/07/2025: Publication references added.
02/04/2025: Study's existence confirmed by the NIHR.