Impact of a Musical Intervention in Older Adults (ARA Project - Armonía Recreativa Para El Adulto Mayor)

NCT06787820 | Recruiting DMC

• 2 other identifiers: UDP 01-2024Fondo Académicas Res 150/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Older People

Keywords

Music; Elderly persons; Institutionalized

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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)

  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.

Study Arms (2)

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.

Behavioral: Music intervention

Listen to music

NO INTERVENTION

Participants will attend three concerts, one per month, held within the care facility

Interventions

Music intervention BEHAVIORAL

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.

Also known as: Music therapy

Music intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Older adults residing in a protected residence.
• Consent to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Diego Portales: lead

Study Sites (1)

Fundación Las Rosas

Santiago, Santiago Metropolitan, 8390865, Chile

RECRUITING

Related Publications (16)

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  PMID: 15543492 BACKGROUND

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  PMID: 36619838 BACKGROUND

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  PMID: 28302633 BACKGROUND

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  PMID: 24847296 BACKGROUND

• Edwards 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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• Grau-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.

  PMID: 36177875 BACKGROUND

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  PMID: 18826699 BACKGROUND

• Russell 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.

  PMID: 8576833 BACKGROUND

• Sarkamo 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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• Stietz 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.

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  PMID: 3595467 BACKGROUND

• Zhang Y, Cai J, An L, Hui F, Ren T, Ma H, Zhao Q. Does music therapy enhance behavioral and cognitive function in elderly dementia patients? A systematic review and meta-analysis. Ageing Res Rev. 2017 May;35:1-11. doi: 10.1016/j.arr.2016.12.003. Epub 2016 Dec 23.

  PMID: 28025173 BACKGROUND

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Leonie Kausel, PhD

CONTACT

+56987112946; leonie.kausel@mail.udp.cl

Vanessa Corrales, Psychologist

CONTACT

+5697565 6900; vanessa.corrales@mail.udp.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 22, 2025
• Study Start: June 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 22, 2025

Record last verified: 2024-06

Locations

CL (1)