PainNCT04229446
Music Based Caregiving in Patients With Pain and Dementia
A study testing Music based caregiving in people with Pain and Dementia, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Music based caregiving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 2 sitesNorway
- Study dates
- 5 Aug 2019to 5 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients living in one of the included nursing homes in Oslo or Trondheim will be included in the first descriptive phase
- Patients will be included in the intervention part if they report moderate pain or more (≥3 on MOBID) and mild dementia or more (≥1 on CDR).
Who cannot join
- 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),or if they do not understand the Norwegian language.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo University Hospital
Oslo
St. Olavs hospital Trondheim University Hospital
Trondheim
About this study
Official title: In What Way do Music-based Caregiving Influence Pain, Daily Activity, QOL, Neuropsychiatric Symptoms, and Medication in Patients With Dementia
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. Patients with dementia disease will be recruited from nursing homes in Trondheim and Oslo, and each ward at the nursing homes 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 general activity, as well as reduce other symptoms in nursing home patients with dementia and pain compared to baseline.
Read the detailed description
This is a cluster-randomized controlled trial including patients with dementia and pain living at different wards at eight nursing homes.
- About 12 nursing homes are selected to participate in Trondheim and in Oslo.
- All patients at the included nursing homes will be screened with respect to dementia and pain (see screening tools later). If patients have dementia and report pain (≥3 on MOBID 2) they will be included in the intervention part of the study (n=240).
- The included patients will then have a clinical examination of pain and pain management by expert physicians (see below). Evaluation of the use of analgesics and psychopharmacological medication will be performed. Inappropriate medication (both too much and too little) will be corrected in collaboration with the nursing home doctor.
- In addition to the clinical examination of pain, the investigators will measure total daily physical activity, ADL, QOL, and neuropsychiatric symptoms on all included patients.
- After the pre-test - a randomization of the wards into intervention wards or control wards will be performed.
- About five staff members at each of the wards randomized to the intervention group will receive education in the MBC before intervention.
- A post-test just after the intervention has ended, pain, total daily physical activity, ADL, QOL, and neuropsychiatric symptoms will be measured.
- Conditions
- Pain, Dementia, Music, Activity, Motor, Quality of Life
- Being tested
- Music based caregiving
- Medical subject headings
- Pain, Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music based caregivingBehavioural
The intervention (MBC) consists of daily individualized prerecorded music integrated with activity with about 30 minutes duration, combined with a one hour active session in groups twice weekly. The music will be selected based on individualized preferences from the patients or their family. The music will also be adapted to the day rhythm; awakening in the morning, support activities during the day, or for sleep in the evening. The healthcare worker will bring playback equipment e.g. a CD-player to the patient room. In addition will two weekly sessions in groups be performed (each on one hour) with music and movement.
| Study group | Role | What they receive |
|---|---|---|
| Receive the music based intervention | Experimental | After the healthcare workers have accomplished the MBC program the eight week intervention program will be applied by the trained staff at the intervention wards. The intervention (MBC) consists of daily individualized prerecorded music integrated with activity with about 30 minutes duration, combined with a one hour active session in groups twice weekly. The music will be selected based on individualized preferences from the patients or their family. The music will also be adapted to the day rhythm; awakening in the morning, support activities during the day, or for sleep in the evening. The healthcare worker will bring playback equipment e.g. a CD-player to the patient room. In addition will two weekly sessions in groups be performed (each on one hour) with music and movement. The movement will be adapted to their physical capacity. Receives: Behavioral: Music based caregiving |
| Standard care group | No intervention | Standard care for participants in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Occurence
MOBID 2 observation instrument. The assessment of inferred pain intensity is observed based on patient'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 reliable, valid and time-effective to assess pain in patients with severe dementia. The investigators will use MOBID-2 for assessment of pain in all the patients with dementia. Scoring range is 0-10, the higher the score the more pain.
Measured: 8 weeks
Secondary outcomes (6)
The Total Daily Physical Activity
Two three-axis accelerometers attached to the skin on the right thigh and low back for seven continuous days. By utilizing state-of-the-art machine-learning techniques, the investigators have developed a preliminary activity recognition model for lying, sitting, standing, walking and other activities. This model has been used in the Nord-Trøndelag health study (HUNT4). Specifically, the model captures walking velocity and transitions between postures and activities (e.g. sit-to-stand) and sleep quality/duration.
Measured: 8 weeks
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 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, also the Norwegian version.
Measured: 8 weeks
Neuropsychiatric Symptoms
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 total scoring range is from 0-144, the higher the score the more symptoms. The scale has been validated for patients in nursing homes in Norway.
Measured: 8 weeks
Depression
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. Each question is scored on a two-point scale: 0=absent; 1=mild or intermittent; 2=severe; n/a = unable to evaluate.
Measured: 8 weeks
Level of Quality of Life: QUALID-scale
Quality of Life in Late-Stage Dementia (QUALID) measures QOL in patients with severe dementia based on information and observations from nurses about the patient's emotions and behavior. Dementia Quality of Life (DQoL) will also be used as QUALID-scale is an observation scale, and there is a lack of studies comparing self-reported and observations QoL in those with dementia, the investigators 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. Scoring range is from 11-55, the higher the score the worse QOL.
Measured: 8 weeks
Aids of Daily Living
Barthel's Activities of Daily Living Index (ADL) is a screening instrument for patients' daily life functioning. This 10-point scale measures patients' degree of self-reliance with a total score ranging from 0 to 20. Lower scores indicate greater dependence on nursing care.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start5 Aug 2019
- Primary completion5 Aug 2020
- Study completion5 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster-randomized controlled trial including patients with dementia and pain living at different wards at nursing homes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Midt-Norge, St. Olavs Hospital, University of Oslo, University of Bergen, Norwegian Centre for Ageing and Health
- Responsible party
- Principal investigator, Tone Rustøen, Oslo University Hospital
- Investigators
- Tone Rustøen, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229446
- Sponsor's protocol ID
- 2018/2519
- Status last verified
- Feb 2023
- First submitted
- 9 Oct 2019
- Last updated
- 7 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Myrenget ME, Sandvik R, Borchgrevink P, Selbaek G, Smastuen M, Rangul V, Hapnes O, Myskja A, Husebo B, Rustoen T. The effect of a music-based care intervention on neuropsychiatric symptoms: secondary analysis of a cluster-randomised controlled study in nursing home residents with dementia and pain. BMC Geriatr. 2026 Mar 19;26(1):592. doi: 10.1186/s12877-026-07301-4.
PubMed 41857732Myrenget ME, Rustoen T, Myskja A, Smastuen M, Rangul V, Hapnes O, Borchgrevink PC, Butler S, Selbaek G, Husebo B, Sandvik R. The effect of a music-based caregiving intervention on pain intensity in nursing home patients with dementia: a cluster-randomized controlled study. Pain. 2024 Jul 1;165(7):1550-1558. doi: 10.1097/j.pain.0000000000003156. Epub 2024 Jan 2.
PubMed 38189182Myrenget ME, Borchgrevink PC, Rustoen T, Butler S, Thorsvik D, Smastuen MC, Sandvik R. Chronic pain conditions and use of analgesics among nursing home patients with dementia. Pain. 2023 May 1;164(5):1002-1011. doi: 10.1097/j.pain.0000000000002794. Epub 2022 Dec 21.
PubMed 36542760
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In What Way do Music-based Caregiving Influence Pain, Daily Activity, QOL, Neuropsychiatric Symptoms, and Medication in Patients With Dementia
- ClinicalTrials.gov ID
- NCT04229446
- Acronym / sponsor ID
- 2018/2519
- Conditions
- Pain, Dementia, Music, Activity, Motor, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Helse Midt-Norge, St. Olavs Hospital, University of Oslo, University of Bergen, Norwegian Centre for Ageing and Health
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 5 Aug 2020 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 7 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Patients with dementia disease will be recruited from nursing homes in Trondheim and Oslo, and each ward at the nursing homes 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 general activity, as well as reduce other symptoms in nursing home patients with dementia and pain compared to baseline.
Detailed description
This is a cluster-randomized controlled trial including patients with dementia and pain living at different wards at eight nursing homes.
- About 12 nursing homes are selected to participate in Trondheim and in Oslo.
- All patients at the included nursing homes will be screened with respect to dementia and pain (see screening tools later). If patients have dementia and report pain (≥3 on MOBID 2) they will be included in the intervention part of the study (n=240).
- The included patients will then have a clinical examination of pain and pain management by expert physicians (see below). Evaluation of the use of analgesics and psychopharmacological medication will be performed. Inappropriate medication (both too much and too little) will be corrected in collaboration with the nursing home doctor.
- In addition to the clinical examination of pain, the investigators will measure total daily physical activity, ADL, QOL, and neuropsychiatric symptoms on all included patients.
- After the pre-test - a randomization of the wards into intervention wards or control wards will be performed.
- About five staff members at each of the wards randomized to the intervention group will receive education in the MBC before intervention.
- A post-test just after the intervention has ended, pain, total daily physical activity, ADL, QOL, and neuropsychiatric symptoms will be measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a cluster-randomized controlled trial including patients with dementia and pain living at different wards at nursing homes.
| Arm | Type | Receives |
|---|---|---|
| Receive the music based intervention | Experimental | Behavioral: Music based caregivingAfter the healthcare workers have accomplished the MBC program the eight week intervention program will be applied by the trained staff at the intervention wards. The intervention (MBC) consists of daily individualized prerecorded music integrated with activity with about 30 minutes duration, combined with a one hour active session in groups twice weekly. The music will be selected based on individualized preferences from the patients or their family. The music will also be adapted to the day rhythm; awakening in the morning, support activities during the day, or for sleep in the evening. The healthcare worker will bring playback equipment e.g. a CD-player to the patient room. In addition will two weekly sessions in groups be performed (each on one hour) with music and movement. The movement will be adapted to their physical capacity. |
| Standard care group | No intervention | –Standard care for participants in this group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients living in one of the included nursing homes in Oslo or Trondheim will be included in the first descriptive phase
- Patients will be included in the intervention part if they report moderate pain or more (≥3 on MOBID) and mild dementia or more (≥1 on CDR).
Key exclusion criteria (1 listed)
- 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),or if they do not understand the Norwegian language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music based caregivingThe intervention (MBC) consists of daily individualized prerecorded music integrated with activity with about 30 minutes duration, combined with a one hour active session in groups twice weekly. The music will be selected based on individualized preferences from the patients or their family. The music will also be adapted to the day rhythm; awakening in the morning, support activities during the day, or for sleep in the evening. The healthcare worker will bring playback equipment e.g. a CD-player to the patient room. In addition will two weekly sessions in groups be performed (each on one hour) with music and movement. | Behavioural | Receive the music based intervention |
Primary outcome
Pain Occurence
Time frame: 8 weeks
MOBID 2 observation instrument. The assessment of inferred pain intensity is observed based on patient'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 reliable, valid and time-effective to assess pain in patients with severe dementia. The investigators will use MOBID-2 for assessment of pain in all the patients with dementia. Scoring range is 0-10, the higher the score the more pain.
6 secondary outcomes
The Total Daily Physical Activity
Time frame: 8 weeks
Stage of Dementia Disease
Time frame: 8 weeks
Neuropsychiatric Symptoms
Time frame: 8 weeks
Depression
Time frame: 8 weeks
Level of Quality of Life: QUALID-scale
Time frame: 8 weeks
Aids of Daily Living
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41857732Myrenget ME, Sandvik R, Borchgrevink P, Selbaek G, Smastuen M, Rangul V, Hapnes O, Myskja A, Husebo B, Rustoen T. The effect of a music-based care intervention on neuropsychiatric symptoms: secondary analysis of a cluster-randomised controlled study in nursing home residents with dementia and pain. BMC Geriatr. 2026 Mar 19;26(1):592. doi: 10.1186/s12877-026-07301-4.
- Derived from this study: PubMed 38189182Myrenget ME, Rustoen T, Myskja A, Smastuen M, Rangul V, Hapnes O, Borchgrevink PC, Butler S, Selbaek G, Husebo B, Sandvik R. The effect of a music-based caregiving intervention on pain intensity in nursing home patients with dementia: a cluster-randomized controlled study. Pain. 2024 Jul 1;165(7):1550-1558. doi: 10.1097/j.pain.0000000000003156. Epub 2024 Jan 2.
- Derived from this study: PubMed 36542760Myrenget ME, Borchgrevink PC, Rustoen T, Butler S, Thorsvik D, Smastuen MC, Sandvik R. Chronic pain conditions and use of analgesics among nursing home patients with dementia. Pain. 2023 May 1;164(5):1002-1011. doi: 10.1097/j.pain.0000000000002794. Epub 2022 Dec 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tone Rustøen, PhD principal investigator
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music based caregiving in people with Pain and Dementia, run by Oslo University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Occurence (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04229446, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.