Older PeopleARANCT06787820
Impact of a Musical Intervention in Older Adults (ARA Project - Armonía Recreativa Para El Adulto Mayor)
A study testing Music intervention in people with Older People, run by University Diego Portales at 1 site in Chile.
Trial summary
Currently, the world is facing the challenge of population aging. At this stage of life, various deteriorations, such as cognitive decline, begin to appear, significantly impairing the quality of life. Therefore, it is imperative to seek interventions that can positively impact the life trajectory of older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older People
- What is being tested?
- Music intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- 1 Jun 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older adults residing in a protected residence.
- Consent to participate in the study.
Who cannot join
- Physical or cognitive impairments that prevent participation in musical intervention activities.
- Mild cognitive impairment determined by the GDS-3 scale, reported by the residence therapists.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Fundación Las Rosas
Santiago, Santiago Metropolitan, 8390865
Leonie Kausel, 56987112946, leonie.kausel@mail.udp.cl
About this study
Official title: Evaluation of the Cognitive and Socioemotional Impact of a Musical Intervention in Older Adults
Currently, the world is facing the challenge of population aging. At this stage of life, various deteriorations, such as cognitive decline, begin to appear, significantly impairing the quality of life. Therefore, it is imperative to seek interventions that can positively impact the life trajectory of older adults. While the cognitive benefits of musical interventions for children and young people are well-documented, there is a lack of evidence regarding their effects on the cognitive and socioemotional well-being of institutionalized older adults.
To address this, the investigators will conduct a non-randomized clinical trial at Fundación Las Rosas, which operates various homes for the elderly. The trial will involve two groups: a control group and an experimental group. The control group will attend concerts held within the care facility, while the experimental group will participate in a music workshop once a week for three months.
To evaluate the outcomes, cognitive and socioemotional assessments will be conducted at three points: prior to the musical intervention (baseline), at the end of the intervention period, and one month after the interventions conclude (follow-up). The results will provide valuable insights to support the development and implementation of cost-effective non-pharmacological interventions, specifically musical interventions, to promote well-being in older adults by demonstrating their applicability and effectiveness within the national context. By assessing the intervention's impact on both cognitive and socioemotional dimensions, this study will also contribute to a deeper understanding of how these skills can be developed and promoted among older adults.
Read the detailed description
The world is facing a gradual aging of the population. It is estimated that in the coming years, people over 60 years old will outnumber children under 10 years old, and by 2050, the population over 60 will surpass adolescents and young adults worldwide. Additionally, the population of those over 80 years old is expected to triple by 2050. Chile is also following this global trend. This reality underscores the need to understand how to ensure well-being during this life stage is not diminished by natural aging processes and their context, such as cognitive decline or the weakening of socioemotional well-being.
Music has been a form of expression accompanying humans since ancient times. It is a powerful generator of emotions , evocative of memories, and a creator of social cohesion. Importantly, it has shown positive effects on both cognitive and socioemotional aspects when musical interventions are implemented in older adults, in both clinical cases and typical aging. Active musical interventions include activities such as singing, playing an instrument, and/or moving to the rhythm of the music. The success of these interventions is proposed to be due to their requirements for multisensory integration, cognitive demands, promotion of social interaction and bond formation, perception as enjoyable and entertaining, and inherent motivational qualities that evoke positive emotions. These types of interventions could be highly relevant in the national context, for example, for the "Active Aging" program of the National Service for the Elderly (SENAMA) of the Ministry of Social Development and Family, which seeks to have self-sufficient older adults participate in activities that promote active aging, as well as for the National Comprehensive Health Plan for Older Adults, which proposes a series of actions framed, among other things, in the prevention of health problems. Therefore, it is urgent to evaluate the effectiveness of these interventions in our sociocultural context, particularly in nursing homes where residents often lack an extended network to care for them, making these interventions particularly important for those in vulnerable situations, and where such interventions have shown positive impacts.
This study proposes to evaluate the impact on both cognitive and socioemotional dimensions of a musical intervention in institutionalized older adults. Importantly, a study is proposed in which the participating institutions will be randomized to either the intervention group, where older adults will receive the musical intervention, or the control group, where they will not receive the intervention, following current recommendations for evaluating the impact of musical interventions in prevention and rehabilitation contexts. Evaluations of cognitive functions and socioemotional well-being will be conducted at three time points for both groups: baseline pre-intervention, post-intervention immediately after the intervention concludes, and follow-up one month after the intervention concludes. This design will elucidate the effect of the musical intervention on older adults and the persistence of these changes. The results of this study will be a starting point to promote research on musical interventions focused on the well-being of the older population in Chile. Additionally, they will allow applications for funding to continue investigating the most effective forms of intervention for this age group and understanding the mechanisms by which these interventions act, for example, using neurobiological activity measurement techniques from neuroscience.
General Aim
To evaluate the impact on cognitive and socioemotional dimensions of a musical intervention in older adults residing in a nursing home.
Specific Aim
- To determine changes in cognitive functions and socioemotional well-being pre- and post-musical intervention in both the intervention and control groups.
- To assess the persistence of cognitive and socioemotional changes post-intervention in both groups.
- To analyze similarities and differences in cognitive functions and socioemotional well-being across all evaluation stages (pre, post, follow-up) between the intervention and control groups.
Methods
A non-randomized clinical study, quasi-experimental in nature, will be conducted, recording changes at three time points: a) pre-intervention, b) post-intervention, and c) follow-up.
Senior citizen Residences The study will take place at Fundación Las Rosas in Santiago, Chile. Each participant will be individually invited and informed about the study, with all consent points reviewed in a conducive environment for uninterrupted conversation.
Interventions
- Control:** Participants will attend concerts held within the care facility
- Experimental:** Group musical intervention once a week in 60-minute sessions for three months, a sufficient duration to observe changes (Mathew et al., 2017). Sessions will be designed by the principal investigator and a music teacher, and conducted by the experienced music teacher. Activities will include experiencing sound qualities (pitch, duration, intensity, and timbre) through movement, with a focus on collective participation and learning. Musical preferences of participants will be considered in the session design.
Evaluations and outcomes
Evaluations of cognitive and socioemotional functioning will be assessed three times: 1) at baseline, prior to the musical intervention; 2) post-intervention, immediately after the intervention concludes; and 3) follow up, one month after the intervention concludes.
During the second evaluation (post-intervention), a Satisfaction Survey will also be administered to the intervention group to gauge acceptance and feedback for refining the intervention.
This study aims to enhance understanding of the effects of musical interventions on older adults and provide valuable data to develop more effective programs, ultimately improving the quality of life for the elderly population in Chile.
- Conditions
- Older People
- Being tested
- Music intervention
- Keywords
- Music, Elderly persons, Institutionalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionBehavioural
Also called Music therapy
The musical intervention conducted at the senior home focused on the development of rhythmic and vocal skills, as well as the creation of educational experiences that promoted the acquisition of these competencies. To achieve this, both conventional percussion instruments, such as claves, tambourines, woodblocks, and triangles, and unconventional elements, such as buckets played with drumsticks, sheets of paper, spoons, ribbons, elastic bands, and a parachute, were used to mark the rhythm during the singing sessions. The selected songs were chosen based on the musical styles mentioned by the participants during the pre-intervention interview. Furthermore, participants were given the opportunity to showcase their progress at the end of the activity, with the aim of sharing these achievements with family and friends at the home.
| Study group | Role | What they receive |
|---|---|---|
| Music intervention | Experimental | Group musical intervention once a week in 60-minute sessions for three months, a sufficient duration to observe changes (Mathew et al., 2017). Sessions will be designed by the principal investigator and a music teacher, and conducted by the experienced music teacher. Activities will include experiencing sound qualities (pitch, duration, intensity, and timbre) through movement, with a focus on collective participation and learning. Musical preferences of participants will be considered in the session design. Receives: Behavioral: Music intervention |
| Listen to music | No intervention | Participants will attend three concerts, one per month, held within the care facility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance - Montreal Cognitive Assessment (MoCA)
Montreal Cognitive Assessment (MoCA). This is a screening test that provides a comprehensive evaluation of global cognition and various cognitive functions. Values range from 0 - 30, with a higher score meaning a better outcome.
Measured: These assessments will be administered three times: 1) at baseline, prior to the musical intervention; 2) immediately after the intervention concludes; and 3) follow up, one month after the intervention concludes.
Cognitive performance - Phototest
Phototest. A brief cognitive screening test applicable to illiterate people that through the recognition and naming of images of everyday objects offers insights into facilitated memory, denomination and verbal fluency. It can be used for the detection of cognitive impairment and dementia. Values range from 0 on, because the maximum value depends on how many objects the person recognizes or names. Higher scores mean a better outcome, and a score of 28 or less is an indicator of cognitive decline.
Measured: These assessments will be administered three times: 1) at baseline, prior to the musical intervention; 2) immediately after the intervention concludes; and 3) follow up, one month after the intervention concludes.
Cognitive performance - Test of Executive Functions Free from Schooling Bias (TELE)
Test of Executive Functions Free from Schooling Bias (TELE, Test de funciones Ejecutivas Libre de sesgo por Escolaridad).
The TELE consists of an executive function evaluation task that screens inhibitory control, sustained attention, verbal working memory and processing speed. Values range from 0 - 12, where higher scores mean a better outcome.
Measured: These assessments will be administered three times: 1) at baseline, prior to the musical intervention; 2) immediately after the intervention concludes; and 3) follow up, one month after the intervention concludes.
Socioemotional performance - UCLA Loneliness Scale
University of California Los Angeles Loneliness Scale (UCLA Loneliness Scale). A scale to detect the feeling of loneliness through 10 questions that score between 1 and 4 points, allowing a minimum score of 10 and a maximum of 40. Higher scores mean a better outcome.
Measured: These assessments will be administered three times: 1) at baseline, prior to the musical intervention; 2) immediately after the intervention concludes; and 3) follow up, one month after the intervention concludes.
Socioemotional performance - Geriatric Depression Scale (GDS)
Geriatric Depression Scale (GDS). This is a self-report instrument composed of 30 items that measure the presence of depressive symptomatology through direct questions, 20 of which measure the presence of symptoms ("Do you feel that your life is empty?"), while 10 are considered inverse items ("Are you basically satisfied with your life?"). It is a dichotomous scale in which the respondent answers yes or no. The scores range from 0 - 30, where high scores indicate a worse outcome, suggesting high risks of depression.
Measured: These assessments will be administered three times: 1) at baseline, prior to the musical intervention; 2) immediately after the intervention concludes; and 3) follow up, one month after the intervention concludes.
Secondary outcomes (1)
Functionality performance - Activities of Daily Living Questionnaire (ADLQ)
Activities of Daily Living Questionnaire (ADLQ). This questionnaire asks about functionality in every day life activities, using a 4-point scale to measure functional capacity. The score ranges from 0 - 100, where higher scores indicate a worse outcome, suggesting higher risks of significant functional impairment in daily activities.
Measured: These assessments will be administered three times: 1) at baseline, prior to the musical intervention; 2) immediately after the intervention concludes; and 3) follow up, one month after the intervention concludes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Jun 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Older PeopleStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Control: Participants will attend concerts held within the care facility Experimental: Group musical intervention once a week in 60-minute sessions for three months, a sufficient duration to observe changes (Mathew et al., 2017). Sessions will be designed by the principal investigator and a music teacher, and conducted by the experienced music teacher. Activities will include experiencing sound qualities (pitch, duration, intensity, and timbre) through movement, with a focus on collective participation and learning. Musical preferences of participants will be considered in the session design.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Diego Portales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonie Kausel, University Diego Portales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787820
- Sponsor's protocol ID
- UDP 01-2024
- Other IDs
- Fondo Académicas Res 150/2023
- Acronym
- ARA
- Status last verified
- Jun 2024
- First submitted
- 3 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carnero-Pardo C, Montoro-Rios MT. [The photo test]. Rev Neurol. 2004 Nov 1-15;39(9):801-6. Spanish.
PubMed 15543492Caldichoury N, Soto-Anari M, Camargo L, Porto MF, Herrera-Pino J, Shelach S, Rivera-Fernandez C, Ramos-Henderson M, Gargiulo PA, Lopez N. Clinical utility of Phototest via teleneuropsychology in Chilean rural older adults. Dement Neuropsychol. 2022 Jul-Sep;16(3):316-323. doi: 10.1590/1980-5764-DN-2021-0082. Epub 2022 Jun 24.
PubMed 36619838Law LN, Zentner M. Assessing musical abilities objectively: construction and validation of the profile of music perception skills. PLoS One. 2012;7(12):e52508. doi: 10.1371/journal.pone.0052508. Epub 2012 Dec 28.
PubMed 23285071Velarde-Mayol C, Fragua-Gil S, Garcia-de-Cecilia JM. [Validation of the UCLA loneliness scale in an elderly population that live alone]. Semergen. 2016 Apr;42(3):177-83. doi: 10.1016/j.semerg.2015.05.017. Epub 2015 Jul 14. Spanish.
PubMed 26187595Abraha I, Rimland JM, Trotta FM, Dell'Aquila G, Cruz-Jentoft A, Petrovic M, Gudmundsson A, Soiza R, O'Mahony D, Guaita A, Cherubini A. Systematic review of systematic reviews of non-pharmacological interventions to treat behavioural disturbances in older patients with dementia. The SENATOR-OnTop series. BMJ Open. 2017 Mar 16;7(3):e012759. doi: 10.1136/bmjopen-2016-012759.
PubMed 28302633Boer D, Abubakar A. Music listening in families and peer groups: benefits for young people's social cohesion and emotional well-being across four cultures. Front Psychol. 2014 May 8;5:392. doi: 10.3389/fpsyg.2014.00392. eCollection 2014.
PubMed 24847296Edwards E, St Hillaire-Clarke C, Frankowski DW, Finkelstein R, Cheever T, Chen WG, Onken L, Poremba A, Riddle R, Schloesser D, Burgdorf CE, Wells N, Fleming R, Collins FS. NIH Music-Based Intervention Toolkit: Music-Based Interventions for Brain Disorders of Aging. Neurology. 2023 May 2;100(18):868-878. doi: 10.1212/WNL.0000000000206797. Epub 2023 Jan 13.
PubMed 36639235Grau-Sanchez J, Jamey K, Paraskevopoulos E, Dalla Bella S, Gold C, Schlaug G, Belleville S, Rodriguez-Fornells A, Hackney ME, Sarkamo T. Putting music to trial: Consensus on key methodological challenges investigating music-based rehabilitation. Ann N Y Acad Sci. 2022 Dec;1518(1):12-24. doi: 10.1111/nyas.14892. Epub 2022 Sep 30.
PubMed 36177875Juslin PN, Vastfjall D. Emotional responses to music: the need to consider underlying mechanisms. Behav Brain Sci. 2008 Oct;31(5):559-75; discussion 575-621. doi: 10.1017/S0140525X08005293.
PubMed 18826699Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.
PubMed 8576833Sarkamo T. Cognitive, emotional, and neural benefits of musical leisure activities in aging and neurological rehabilitation: A critical review. Ann Phys Rehabil Med. 2018 Nov;61(6):414-418. doi: 10.1016/j.rehab.2017.03.006. Epub 2017 Apr 29.
PubMed 28461128Sihvonen AJ, Sarkamo T, Leo V, Tervaniemi M, Altenmuller E, Soinila S. Music-based interventions in neurological rehabilitation. Lancet Neurol. 2017 Aug;16(8):648-660. doi: 10.1016/S1474-4422(17)30168-0. Epub 2017 Jun 26.
PubMed 28663005Stietz J, Pollerhoff L, Kurtz M, Li SC, Reiter AMF, Kanske P. The ageing of the social mind: replicating the preservation of socio-affective and the decline of socio-cognitive processes in old age. R Soc Open Sci. 2021 Aug 25;8(8):210641. doi: 10.1098/rsos.210641. eCollection 2021 Aug.
PubMed 34457343Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.
PubMed 7183759Heinze HG, Bohn U. [Iodine-131 therapy of autonomous adenoma of the thyroid. 7-year results]. Dtsch Med Wochenschr. 1987 Jul 3;112(27):1073-9. doi: 10.1055/s-2008-1068196. German.
PubMed 3595467
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cognitive and Socioemotional Impact of a Musical Intervention in Older Adults
- ClinicalTrials.gov ID
- NCT06787820
- Acronym / sponsor ID
- ARA / UDP 01-2024
- Conditions
- Older People
- Keywords
- Music, Elderly persons, Institutionalized
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Diego PortalesUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, the world is facing the challenge of population aging. At this stage of life, various deteriorations, such as cognitive decline, begin to appear, significantly impairing the quality of life. Therefore, it is imperative to seek interventions that can positively impact the life trajectory of older adults. While the cognitive benefits of musical interventions for children and young people are well-documented, there is a lack of evidence regarding their effects on the cognitive and socioemotional well-being of institutionalized older adults.
To address this, the investigators will conduct a non-randomized clinical trial at Fundación Las Rosas, which operates various homes for the elderly. The trial will involve two groups: a control group and an experimental group. The control group will attend concerts held within the care facility, while the experimental group will participate in a music workshop once a week for three months.
To evaluate the outcomes, cognitive and socioemotional assessments will be conducted at three points: prior to the musical intervention (baseline), at the end of the intervention period, and one month after the interventions conclude (follow-up). The results will provide valuable insights to support the development and implementation of cost-effective non-pharmacological interventions, specifically musical interventions, to promote well-being in older adults by demonstrating their applicability and effectiveness within the national context. By assessing the intervention's impact on both cognitive and socioemotional dimensions, this study will also contribute to a deeper understanding of how these skills can be developed and promoted among older adults.
Detailed description
The world is facing a gradual aging of the population. It is estimated that in the coming years, people over 60 years old will outnumber children under 10 years old, and by 2050, the population over 60 will surpass adolescents and young adults worldwide. Additionally, the population of those over 80 years old is expected to triple by 2050. Chile is also following this global trend. This reality underscores the need to understand how to ensure well-being during this life stage is not diminished by natural aging processes and their context, such as cognitive decline or the weakening of socioemotional well-being.
Music has been a form of expression accompanying humans since ancient times. It is a powerful generator of emotions , evocative of memories, and a creator of social cohesion. Importantly, it has shown positive effects on both cognitive and socioemotional aspects when musical interventions are implemented in older adults, in both clinical cases and typical aging. Active musical interventions include activities such as singing, playing an instrument, and/or moving to the rhythm of the music. The success of these interventions is proposed to be due to their requirements for multisensory integration, cognitive demands, promotion of social interaction and bond formation, perception as enjoyable and entertaining, and inherent motivational qualities that evoke positive emotions. These types of interventions could be highly relevant in the national context, for example, for the "Active Aging" program of the National Service for the Elderly (SENAMA) of the Ministry of Social Development and Family, which seeks to have self-sufficient older adults participate in activities that promote active aging, as well as for the National Comprehensive Health Plan for Older Adults, which proposes a series of actions framed, among other things, in the prevention of health problems. Therefore, it is urgent to evaluate the effectiveness of these interventions in our sociocultural context, particularly in nursing homes where residents often lack an extended network to care for them, making these interventions particularly important for those in vulnerable situations, and where such interventions have shown positive impacts.
This study proposes to evaluate the impact on both cognitive and socioemotional dimensions of a musical intervention in institutionalized older adults. Importantly, a study is proposed in which the participating institutions will be randomized to either the intervention group, where older adults will receive the musical intervention, or the control group, where they will not receive the intervention, following current recommendations for evaluating the impact of musical interventions in prevention and rehabilitation contexts. Evaluations of cognitive functions and socioemotional well-being will be conducted at three time points for both groups: baseline pre-intervention, post-intervention immediately after the intervention concludes, and follow-up one month after the intervention concludes. This design will elucidate the effect of the musical intervention on older adults and the persistence of these changes. The results of this study will be a starting point to promote research on musical interventions focused on the well-being of the older population in Chile. Additionally, they will allow applications for funding to continue investigating the most effective forms of intervention for this age group and understanding the mechanisms by which these interventions act, for example, using neurobiological activity measurement techniques from neuroscience.
General Aim
To evaluate the impact on cognitive and socioemotional dimensions of a musical intervention in older adults residing in a nursing home.
Specific Aim
- To determine changes in cognitive functions and socioemotional well-being pre- and post-musical intervention in both the intervention and control groups.
- To assess the persistence of cognitive and socioemotional changes post-intervention in both groups.
- To analyze similarities and differences in cognitive functions and socioemotional well-being across all evaluation stages (pre, post, follow-up) between the intervention and control groups.
Methods
A non-randomized clinical study, quasi-experimental in nature, will be conducted, recording changes at three time points: a) pre-intervention, b) post-intervention, and c) follow-up.
Senior citizen Residences The study will take place at Fundación Las Rosas in Santiago, Chile. Each participant will be individually invited and informed about the study, with all consent points reviewed in a conducive environment for uninterrupted conversation.
Interventions
- Control:** Participants will attend concerts held within the care facility
- Experimental:** Group musical intervention once a week in 60-minute sessions for three months, a sufficient duration to observe changes (Mathew et al., 2017). Sessions will be designed by the principal investigator and a music teacher, and conducted by the experienced music teacher. Activities will include experiencing sound qualities (pitch, duration, intensity, and timbre) through movement, with a focus on collective participation and learning. Musical preferences of participants will be considered in the session design.
Evaluations and outcomes
Evaluations of cognitive and socioemotional functioning will be assessed three times: 1) at baseline, prior to the musical intervention; 2) post-intervention, immediately after the intervention concludes; and 3) follow up, one month after the intervention concludes.
During the second evaluation (post-intervention), a Satisfaction Survey will also be administered to the intervention group to gauge acceptance and feedback for refining the intervention.
This study aims to enhance understanding of the effects of musical interventions on older adults and provide valuable data to develop more effective programs, ultimately improving the quality of life for the elderly population in Chile.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Control: Participants will attend concerts held within the care facility Experimental: Group musical intervention once a week in 60-minute sessions for three months, a sufficient duration to observe changes (Mathew et al., 2017). Sessions will be designed by the principal investigator and a music teacher, and conducted by the experienced music teacher. Activities will include experiencing sound qualities (pitch, duration, intensity, and timbre) through movement, with a focus on collective participation and learning. Musical preferences of participants will be considered in the session design.
| Arm | Type | Receives |
|---|---|---|
| Music intervention | Experimental | Behavioral: Music interventionGroup musical intervention once a week in 60-minute sessions for three months, a sufficient duration to observe changes (Mathew et al., 2017). Sessions will be designed by the principal investigator and a music teacher, and conducted by the experienced music teacher. Activities will include experiencing sound qualities (pitch, duration, intensity, and timbre) through movement, with a focus on collective participation and learning. Musical preferences of participants will be considered in the session design. |
| Listen to music | No intervention | –Participants will attend three concerts, one per month, held within the care facility |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Older adults residing in a protected residence.
- Consent to participate in the study.
Key exclusion criteria (2 listed)
- Physical or cognitive impairments that prevent participation in musical intervention activities.
- Mild cognitive impairment determined by the GDS-3 scale, reported by the residence therapists.
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 interventionAlso: Music therapyThe musical intervention conducted at the senior home focused on the development of rhythmic and vocal skills, as well as the creation of educational experiences that promoted the acquisition of these competencies. To achieve this, both conventional percussion instruments, such as claves, tambourines, woodblocks, and triangles, and unconventional elements, such as buckets played with drumsticks, sheets of paper, spoons, ribbons, elastic bands, and a parachute, were used to mark the rhythm during the singing sessions. The selected songs were chosen based on the musical styles mentioned by the participants during the pre-intervention interview. Furthermore, participants were given the opportunity to showcase their progress at the end of the activity, with the aim of sharing these achievements with family and friends at the home. | Behavioural | Music intervention |
Primary outcome
Cognitive performance - Montreal Cognitive Assessment (MoCA)
Time frame: These assessments will be administered three times: 1) at baseline, prior to the musical intervention; 2) immediately after the intervention concludes; and 3) follow up, one month after the intervention concludes.
Montreal Cognitive Assessment (MoCA). This is a screening test that provides a comprehensive evaluation of global cognition and various cognitive functions. Values range from 0 - 30, with a higher score meaning a better outcome.
Cognitive performance - Phototest
Time frame: These assessments will be administered three times: 1) at baseline, prior to the musical intervention; 2) immediately after the intervention concludes; and 3) follow up, one month after the intervention concludes.
Phototest. A brief cognitive screening test applicable to illiterate people that through the recognition and naming of images of everyday objects offers insights into facilitated memory, denomination and verbal fluency. It can be used for the detection of cognitive impairment and dementia. Values range from 0 on, because the maximum value depends on how many objects the person recognizes or names. Higher scores mean a better outcome, and a score of 28 or less is an indicator of cognitive decline.
Cognitive performance - Test of Executive Functions Free from Schooling Bias (TELE)
Time frame: These assessments will be administered three times: 1) at baseline, prior to the musical intervention; 2) immediately after the intervention concludes; and 3) follow up, one month after the intervention concludes.
Test of Executive Functions Free from Schooling Bias (TELE, Test de funciones Ejecutivas Libre de sesgo por Escolaridad). The TELE consists of an executive function evaluation task that screens inhibitory control, sustained attention, verbal working memory and processing speed. Values range from 0 - 12, where higher scores mean a better outcome.
Socioemotional performance - UCLA Loneliness Scale
Time frame: These assessments will be administered three times: 1) at baseline, prior to the musical intervention; 2) immediately after the intervention concludes; and 3) follow up, one month after the intervention concludes.
University of California Los Angeles Loneliness Scale (UCLA Loneliness Scale). A scale to detect the feeling of loneliness through 10 questions that score between 1 and 4 points, allowing a minimum score of 10 and a maximum of 40. Higher scores mean a better outcome.
Socioemotional performance - Geriatric Depression Scale (GDS)
Time frame: These assessments will be administered three times: 1) at baseline, prior to the musical intervention; 2) immediately after the intervention concludes; and 3) follow up, one month after the intervention concludes.
Geriatric Depression Scale (GDS). This is a self-report instrument composed of 30 items that measure the presence of depressive symptomatology through direct questions, 20 of which measure the presence of symptoms ("Do you feel that your life is empty?"), while 10 are considered inverse items ("Are you basically satisfied with your life?"). It is a dichotomous scale in which the respondent answers yes or no. The scores range from 0 - 30, where high scores indicate a worse outcome, suggesting high risks of depression.
1 secondary outcome
Functionality performance - Activities of Daily Living Questionnaire (ADLQ)
Time frame: These assessments will be administered three times: 1) at baseline, prior to the musical intervention; 2) immediately after the intervention concludes; and 3) follow up, one month after the intervention concludes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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- Background: PubMed 23285071Law LN, Zentner M. Assessing musical abilities objectively: construction and validation of the profile of music perception skills. PLoS One. 2012;7(12):e52508. doi: 10.1371/journal.pone.0052508. Epub 2012 Dec 28.
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- Background: PubMed 24847296Boer D, Abubakar A. Music listening in families and peer groups: benefits for young people's social cohesion and emotional well-being across four cultures. Front Psychol. 2014 May 8;5:392. doi: 10.3389/fpsyg.2014.00392. eCollection 2014.
- Background: PubMed 36639235Edwards E, St Hillaire-Clarke C, Frankowski DW, Finkelstein R, Cheever T, Chen WG, Onken L, Poremba A, Riddle R, Schloesser D, Burgdorf CE, Wells N, Fleming R, Collins FS. NIH Music-Based Intervention Toolkit: Music-Based Interventions for Brain Disorders of Aging. Neurology. 2023 May 2;100(18):868-878. doi: 10.1212/WNL.0000000000206797. Epub 2023 Jan 13.
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- Background: PubMed 28461128Sarkamo T. Cognitive, emotional, and neural benefits of musical leisure activities in aging and neurological rehabilitation: A critical review. Ann Phys Rehabil Med. 2018 Nov;61(6):414-418. doi: 10.1016/j.rehab.2017.03.006. Epub 2017 Apr 29.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Older People, run by University Diego Portales at 1 site in Chile.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonie Kausel, PhD (+56987112946, leonie.kausel@mail.udp.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive performance - Montreal Cognitive Assessment (MoCA) (time frame: These assessments will be administered three times: 1) at baseline, prior to the musical intervention; 2) immediately after the intervention concludes; and 3) follow up, one month after the intervention concludes.). The study lists 5 primary outcomes in all. 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 NCT06787820, which also lists 16 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 22 Jan 2025.