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CompletedNCT06320093SOUNDUpdated Mar 20, 2024

Training Social and Health Care prOfessionals in mUsic-based Therapeutic iNterventions to Support Older People With Dementia

An interventional study of SOUND Intervention in Dementia and Older People, sponsored by Istituto Nazionale di Ricovero e Cura per Anziani. Completed at 3 sites in 3 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-03-20.

Sponsored by Istituto Nazionale di Ricovero e Cura per Anziani · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Oct 2023, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study summary

The study will investigate the effects of an inovative intervention based on the use of music on 45 professionals in the field of dementia, 45 elderly people with dementia.

Read the detailed description

The study aims to develop an innovative therapeutic intervention (SOUND intervention) based on the use of music to improve behavior, mood, well-being, and maintain cognitive function in older people with dementia.

The study will investigate the effects of the SOUND intervention on 45 professionals in the field of dementia, 45 elderly people with dementia, and 5 family caregivers by monitoring quantitative outcome variables that will be measured through psychometric and qualitative scales interpreted through open-ended questions and observations.

02

Conditions studied

  • Dementia
  • Older People

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Keywords

  • dementia
  • older people
  • music
  • caregiver
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 45 is below the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Istituto Nazionale di Ricovero e Cura per Anziani is the lead sponsor of 41 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • mild to moderate dementia
  • no severe hearing and visual impairment or motor problems

Exclusion criteria

Exclusion Criteria:

  • no formal caregiver
  • no informal caregiver
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Sound intervention

    the SOUND intervention is a new and innovative method of applying musical activities in a circle consisting of elderly people with mild-to-moderate dementia, caregivers, family caregivers and young people.

    Other: SOUND Intervention

Interventions

  • OtherSOUND Intervention

    The intervention involved active (vocal and rhythmic production) and passive (listening to musical pieces) musical activities accompanied by motor coordination exercises. It consisted of 12 meetings (2 per week for 6 weeks) of 45 minutes each.

06

What researchers measure

Primary outcomes

  1. Change in mental wellbeing of patients with dementia

    The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing.The WHO-5 consists of five statements, which respondents rate according to the scale below (in relation to the past two weeks): All of the time = 5; Most of the time = 4; More than half of the time = 3; Less than half of the time = 2 Some of the time = 1; At no time = 0. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.

    Time frame: baseline, 12 and 14 weeks later

  2. Change in cognitive status of patients with dementia

    The cognitive status has been evaluated by the Montreal Cognitive Assessment (MOCA) test. MOCA is an assessment tool used globally to detect early onset of dementia among people of old age. The tool is a one-page 30-point test that the physician can administer to check the memory, language, recall, and other markers of cognitive acuity of a patient. Normal cognition: 26-30 points; Mild Cognitive Impairment: 18-25 points; Moderate Cognitive Impairment: 10-17 points; Severe Cognitive Impairment: under 10 points.

    Time frame: baseline, 12 and 14 weeks later

  3. Change in stress of health care providers

    The Burnout Assessment Tool (BAT) is a self-assessment questionnaire that measures parameters associated with Burnout. All items are expressed as statements with five frequency-based response categories (1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always). The total burnout score is calculated as a mean of all 23 items, and a high score is indicative of high levels of burnout.

    Time frame: baseline, 12 and 14 weeks later

07

Study locations

3 sites
  • INRCA Hospital
    Ancona, 60127, Italy
  • Sons do Estamine Associacao
    Trofa, Portugal
  • Associatia Habilitas
    Bucarest, Romania
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06320093
Lead sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
Collaborators
European Union
Responsible party
Sponsor
First posted
Mar 20, 2024
Start date
Oct 3, 2023
Primary completion
Feb 20, 2024
Completion
Feb 20, 2024
Last update
Mar 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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