NCT07831850

Brief Summary

This pilot study evaluated the feasibility and acceptability of a structured, nurse-led active music program for older adults with cognitive impairment living in a long-term care facility. Participants took part in eight group music sessions delivered twice weekly over four consecutive weeks. The program included singing, rhythmic activities, seated movement, music-based reminiscence, cognitive stimulation, and social interaction. Feasibility and acceptability were the primary domains of interest. Cognitive function, depressive symptoms, active participation, sustained attention, and social interaction were also assessed as exploratory outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

1 month

First QC Date

September 15, 2026

Last Update Submit

September 15, 2026

Conditions

Keywords

Older AdultsLong-Term CareNurse-Led InterventionActive MusicMusic-Based InterventionNon-Pharmacological InterventionFeasibilityAcceptabilityNursingPerson-Centered Care

Outcome Measures

Primary Outcomes (5)

  • Participant Retention Rate

    Percentage of enrolled participants who completed the four-week intervention and the post-intervention assessment.

    Through completion of the 4-week intervention

  • Attendance Rate

    Percentage of scheduled intervention sessions attended by participants who completed the program.

    Throughout the 4-week intervention

  • Intervention Delivery

    Proportion of the eight planned intervention sessions successfully delivered as scheduled.

    Throughout the 4-week intervention

  • Participant Satisfaction

    Overall satisfaction with the intervention assessed using a 5-point Likert scale ranging from 1 (completely dissatisfied) to 5 (completely satisfied), with higher scores indicating greater satisfaction.

    Immediately after completion of the 4-week intervention

  • Willingness to Participate Again

    Proportion of participants indicating willingness to participate in the active music program again.

    Immediately after completion of the 4-week intervention

Other Outcomes (5)

  • Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)

    Baseline and within 1 week after completion of the 4-week intervention

  • Change in Depressive Symptoms Assessed by the GDS-15.

    Baseline and within 1 week after completion of the 4-week intervention

  • Active Participation During Intervention Sessions

    During each of the 8 intervention sessions over 4 weeks

  • +2 more other outcomes

Study Arms (1)

Nurse-Led Active Music Program

EXPERIMENTAL

Participants received a structured, group-based active music program led by a registered nurse. The intervention consisted of eight sessions delivered twice weekly over four consecutive weeks, with each session lasting approximately 40 minutes. Activities included temporal orientation, breathing exercises, group singing, song recognition and completion, rhythmic and percussion activities, coordinated seated movements, autobiographical reminiscence, relaxation, and emotional expression.

Behavioral: Nurse-Led Active Music Program

Interventions

Participants received a structured, group-based active music program led by a registered nurse. The program consisted of eight sessions delivered twice weekly over four consecutive weeks, with each session lasting approximately 40 minutes. Sessions included temporal orientation, breathing exercises, group singing, recognition and completion of familiar songs, call-and-response singing, body percussion, simple percussion instruments, coordinated seated movements, autobiographical reminiscence, relaxation, and emotional expression. The musical repertoire was selected according to participants' biographical and musical preferences.

Nurse-Led Active Music Program

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 70 years or older.
  • Permanent residence in the long-term care facility for at least one month.
  • Documented clinical diagnosis or screening result consistent with mild-to-moderate cognitive impairment.
  • Sufficient motor capacity to participate in seated group activities.
  • Adequate or corrected hearing ability to understand verbal instructions and participate in the musical activities.
  • Written informed consent from the participant or, when applicable, from a family member or legal representative.

You may not qualify if:

  • Severe uncorrected hearing impairment.
  • Unstable medical condition, decompensated disease, or terminal illness that could compromise safe participation.
  • Severe uncontrolled neuropsychiatric symptoms, including delusions, hallucinations, or marked agitation.
  • Refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virgen del Rosario Long-Term Care Residence

Roquetas de Mar, Almería, 04740, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Agustíin J Simonelli Muñoz, PhD

    Universidad de Almeria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single-group quasi-experimental pre-post pilot study. All participants received the same nurse-led active music intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Nursing, Physiotherapy and Medicine

Study Record Dates

First Submitted

September 15, 2026

First Posted

September 21, 2026

Study Start

January 19, 2026

Primary Completion

February 27, 2026

Study Completion

February 27, 2026

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the published article may be shared upon reasonable request, subject to ethical, privacy, and data protection requirements.

Time Frame
Beginning after publication of the study results. Availability will be considered upon reasonable request, subject to ethical and data protection requirements.
Access Criteria
De-identified individual participant data may be made available to qualified researchers upon reasonable request to the corresponding author. Requests should include a scientifically sound proposal and will be evaluated considering the study purpose, participant confidentiality, ethical requirements, and applicable data protection regulations.

Locations