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| Name | Class |
|---|---|
| Universidad La Salle, Mexico | OTHER |
| National Polytechnic Institute, Mexico | OTHER |
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Older adults constitute a population whose age-related physiological and cognitive changes predispose them to conditions that are less likely to occur in younger individuals. Dementia encompasses a group of health conditions that primarily affect this age group. These disorders commonly impair mental functions-particularly memory-but they also manifest through behavioral symptoms, such as irritability, and exert a significant impact not only on the affected individual but also on their immediate environment.
In this study, the investigators will implement a structured musical improvisation intervention led by four professional concert musicians. This approach, which has demonstrated effectiveness in other populations, aims to evaluate its effects on the mental and physical health of older adults living with dementia. Additionally, the intervention will be assessed in terms of its potential impact on primary caregivers, thereby exploring its reach beyond the individual diagnosed with dementia.
Previous studies have reported the effectiveness of such interventions, noting improvements in memory, behavioral symptoms, and even overall physical well-being. To date, no studies of this nature have been conducted in our country, making this the first to pursue an extensive exploration of outcomes-not only those traditionally assessed in similar trials, but also a broader evaluation of various dimensions of health in older adults undergoing the intervention. Additionally, caregivers may also benefit from actively participating in these sessions, which are designed to include them from the very beginning. Beyond generating data on the potential effects across different bodily and cognitive functions-knowledge that may become a leading reference in this field-this intervention holds the potential to be scaled up, thereby benefiting a larger population and ultimately enhancing the care provided to older adults living with dementia.
Older adults are a group of people whose age makes them prone to developing conditions they would not have if they were younger. Dementias are a group of health conditions that commonly occur in older adults. They are a group of conditions that affect, among other mental functions, memory; but they often present other behavioral manifestations (such as irritability) and impact not only the person suffering from them, but also those around them. In this study, the investigators will use musical improvisation led by four concert musicians through a structured intervention which has proven effective in other populations-to understand the effects on the mental and physical health of older adults with dementia; the investigators will also assess caregivers to determine whether this intervention has an impact beyond the person with dementia. There is evidence regarding the effectiveness of these treatments, with improvements observed in memory, behavioral symptoms, and even the person's overall physical condition. On the other hand, it will be the caregivers who may also benefit by actively participating in these sessions, which involve them from the very beginning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music therapy in caregiver burden of dementia patients: A quasi-experimental study | Experimental | The intervention will be assessed in terms of its potential impact on primary caregivers, thereby exploring its reach beyond the individual diagnosed with dementia. Additionally, two other outcomes will be assessed as secondary goals: frailty and neuropsychiatric symptoms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Therapy | Other | Each session lasts three hours and includes preparation and rehearsal, an introductory improvisation with musical instruments, improvisation by patients and their caregivers with small percussion instruments, and finally, an artistic reflection involving musicians, caregivers, and patients |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychiatric symptoms | This outcome was assessed with the Neuropsychiatric Inventory Questionnaire, has a score that ranges from 0 to 12, with the lowest score meaning no neuropsychiatric symptoms and 12 the highest neuropsychiatric symptom burden possible. Additionally, if the symptom is present, a severity scale is applied for the symptom, that ranges from 0 to 36. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver burden | The caregiver burden was assessed with two instruments. The first one is the one linked to the NPI-Q, in which the caregiver is asked about the stress a particular symptom raises. This tool goes from a score 0 to 60, with zero the lowest stress possible and 60 the highest stress possible. Additionally, caregiver burden was also measured with the Scale of Caregiver Burden from Zarit & Zarit, that goes from 22 to 110; 22 is the lowest score and burden possible while 110 the highest. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario U Perez | Instituto Nacional de Geriatria, Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Geriatria | Mexico City | Mexico City | 10200 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39388962 | Background | Salihu D, Chutiyami M, Bello UM, Sulaiman SK, Dawa KK, Hepworth A, Adeleye KK, Alruwaili MM. A meta-review of systematic reviews on the effectiveness of music therapy on depression, stress, anxiety and cognitive function in adult's with dementia or cognitive impairment. Geriatr Nurs. 2024 Nov-Dec;60:348-360. doi: 10.1016/j.gerinurse.2024.09.014. Epub 2024 Oct 9. | |
| 38391491 |
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Once the main analysis is finished, the data will be shared upon request to the main researcher.
Data will be stored and available for five years after the final analysis of the main objective.
A brief proposal on the secondary analysis, one page will be needed, with a current academic affiliation. It can be used for undergraduate thesis.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Study Protocol | Sep 24, 2025 | Apr 9, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 24, 2025 | Apr 17, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 24, 2025 | Apr 17, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000073496 | Frailty |
| D015140 | Dementia, Vascular |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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This is a pre-experimental design, in which the participants will be exposed to the intervention and outcomes will be measured before and after the intervention.
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|
| 8 weeks |
| Frailty | The Short Physical Performance Battery, this test explores three different tasks, gait speed, balance and endurance. Each one of the sub-tests has a maximum score of 4 and zero as the lowest possible. By adding up each subtest, the complete battery score ranges from 0 to 12; a cut-off point for frailty of 10 was used. | 8 weeks |
| Depression | This was measured with the GeriatrĂc Depression Scale of 15 items from Yesavage. The lowest score possible reflects a low burden of depression, while the highest could reflect clinical depression. | 8 weeks |
| Ting B, Chen DT, Hsu WT, Tsai CL, Malau IA, Lee SL, Jingling L. Multifaceted Music Therapy for Depression in Dementia: A Network Meta-Analysis of Randomized Controlled Trials. Eur J Investig Health Psychol Educ. 2024 Feb 11;14(2):351-367. doi: 10.3390/ejihpe14020024. |
| 38793079 | Background | Ting B, Su CH, Chen DT, Hsu WT, Tsai CL, Lin PY, Jingling L. The Sound of Memory: Investigating Music Therapy's Cognitive Benefits in Patients with Dementia-A Network Meta-Analysis of Randomized Controlled Trials. J Pers Med. 2024 May 8;14(5):497. doi: 10.3390/jpm14050497. |
| 39234199 | Background | Wong ARK, Ng LTE, Lee MH, Yeow JLH, Lim YJ, Yap KH. The effectiveness of group music reminiscence therapy for people thriving with dementia: A systematic review of randomized controlled trials. Aging Med (Milton). 2024 Aug 17;7(4):528-534. doi: 10.1002/agm2.12344. eCollection 2024 Aug. |
| 38417183 | Background | Xu H, Li A, Apuke OD. The impact of group music therapy in ameliorating the depression among patients with dementia in care homes: A randomized control trial. Geriatr Nurs. 2024 Mar-Apr;56:304-311. doi: 10.1016/j.gerinurse.2024.02.021. Epub 2024 Feb 27. |
| 39185103 | Background | Yuan SH, Silverman MJ, Cevasco-Trotter AM, Wang SG. Ten Reasons Why Neurologists Should Refer Patients With Alzheimer Dementia to Music Therapy. Neurol Clin Pract. 2024 Dec;14(6):e200357. doi: 10.1212/CPJ.0000000000200357. Epub 2024 Aug 16. |
| 39736268 | Background | Borda MG, Landi F, Cederholm T, Venegas-Sanabria LC, Duque G, Wakabayashi H, Barreto GE, Rodriguez-Sanchez I, Canevelli M, Cano-Gutierrez C, Perez-Zepeda MU, Wallace L, Rockwood K, Salas-Carrillo M, Gjestsen M, Testad I, Ballard C, Aarsland D; IPEFUND. Assessment and management of frailty in individuals living with dementia: expert recommendations for clinical practice. Lancet Healthy Longev. 2025 Jan;6(1):100666. doi: 10.1016/j.lanhl.2024.100666. Epub 2024 Dec 27. |
| 39826392 | Background | Mei Z, Zhang Y, Zhao W, Lam C, Luo S, Wang S, Luo S. Music-based interventions for anxiety and depression in older adults with dementia: A systematic review of randomized controlled trials. Complement Ther Clin Pract. 2025 May;59:101951. doi: 10.1016/j.ctcp.2025.101951. Epub 2025 Jan 13. |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |