Cognitive ImpairmentNCT07831850
Nurse-Led Active Music Program in Older Adults With Cognitive Impairment
A study testing Nurse-Led Active Music Program in people with Cognitive Impairment, run by Universidad de Almeria at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Nurse-Led Active Music Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- 19 Jan 2026to 27 Feb 2026
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Virgen del Rosario Long-Term Care Residence
Roquetas de Mar, Almería, 04740
About this study
Official title: Feasibility and Acceptability of a Nurse-Led Active Music Program for Older Adults With Cognitive Impairment in Long-Term Care: A Pilot Quasi-Experimental Study
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.
Read the detailed description
This pilot quasi-experimental study used a single-group pre-post design and was conducted in a long-term care facility in Roquetas de Mar, Almería, Spain. The study was conceived as a proof-of-concept evaluation of a structured non-pharmacological active music intervention delivered in a real-world long-term care setting.
Eleven residents were initially enrolled. Eligible participants were aged 70 years or older, had been permanently residing in the facility for at least one month, and had a documented clinical diagnosis or screening result consistent with mild-to-moderate cognitive impairment.
The intervention consisted of a structured, group-based active music program led by a registered nurse employed at the long-term care facility. It was delivered over four consecutive weeks, with two sessions per week, for a total of eight sessions. Each session lasted approximately 40 minutes and followed a standardized three-phase structure comprising orientation and breathing exercises, active musical and cognitive stimulation, and relaxation and emotional expression.
Activities included group singing, recognition and completion of familiar songs, call-and-response singing, body percussion, simple percussion instruments, coordinated seated movements, and autobiographical reminiscence. The musical repertoire was selected according to participants' biographical and musical preferences.
Feasibility was assessed through participant retention, intervention completion, attendance, and successful delivery of the eight-session program. Acceptability was assessed through overall satisfaction and willingness to participate again. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA), and depressive symptoms using the 15-item Geriatric Depression Scale (GDS-15), at baseline and after completion of the intervention. Active participation, sustained attention, and social interaction were recorded during each intervention session.
- Conditions
- Cognitive Impairment
- Being tested
- Nurse-Led Active Music Program
- Keywords
- Older Adults, Long-Term Care, Nurse-Led Intervention, Active Music, Music-Based Intervention, Non-Pharmacological Intervention, Feasibility, Acceptability, Nursing, Person-Centered Care
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Active Music ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nurse-Led Active Music Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Retention Rate
Percentage of enrolled participants who completed the four-week intervention and the post-intervention assessment.
Measured: Through completion of the 4-week intervention
Attendance Rate
Percentage of scheduled intervention sessions attended by participants who completed the program.
Measured: Throughout the 4-week intervention
Intervention Delivery
Proportion of the eight planned intervention sessions successfully delivered as scheduled.
Measured: 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.
Measured: 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.
Measured: Immediately after completion of the 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start19 Jan 2026
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group quasi-experimental pre-post pilot study. All participants received the same nurse-led active music intervention.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustin J. Simonelli Muñoz, Universidad de Almeria
- Investigators
- Agustíin J Simonelli Muñoz, PhD, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831850
- Sponsor's protocol ID
- UAL-MUSIC-COG-2026
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Nurse-Led Active Music Program for Older Adults With Cognitive Impairment in Long-Term Care: A Pilot Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07831850
- Acronym / sponsor ID
- UAL-MUSIC-COG-2026
- Conditions
- Cognitive Impairment
- Keywords
- Older Adults, Long-Term Care, Nurse-Led Intervention, Active Music, Music-Based Intervention, Non-Pharmacological Intervention, Feasibility, Acceptability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 21 Sep 2026 (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.
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.
Detailed description
This pilot quasi-experimental study used a single-group pre-post design and was conducted in a long-term care facility in Roquetas de Mar, Almería, Spain. The study was conceived as a proof-of-concept evaluation of a structured non-pharmacological active music intervention delivered in a real-world long-term care setting.
Eleven residents were initially enrolled. Eligible participants were aged 70 years or older, had been permanently residing in the facility for at least one month, and had a documented clinical diagnosis or screening result consistent with mild-to-moderate cognitive impairment.
The intervention consisted of a structured, group-based active music program led by a registered nurse employed at the long-term care facility. It was delivered over four consecutive weeks, with two sessions per week, for a total of eight sessions. Each session lasted approximately 40 minutes and followed a standardized three-phase structure comprising orientation and breathing exercises, active musical and cognitive stimulation, and relaxation and emotional expression.
Activities included group singing, recognition and completion of familiar songs, call-and-response singing, body percussion, simple percussion instruments, coordinated seated movements, and autobiographical reminiscence. The musical repertoire was selected according to participants' biographical and musical preferences.
Feasibility was assessed through participant retention, intervention completion, attendance, and successful delivery of the eight-session program. Acceptability was assessed through overall satisfaction and willingness to participate again. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA), and depressive symptoms using the 15-item Geriatric Depression Scale (GDS-15), at baseline and after completion of the intervention. Active participation, sustained attention, and social interaction were recorded during each intervention session.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group quasi-experimental pre-post pilot study. All participants received the same nurse-led active music intervention.
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Active Music Program | Experimental | Behavioral: Nurse-Led Active Music ProgramParticipants 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Nurse-Led Active Music ProgramParticipants 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. | Behavioural | Nurse-Led Active Music Program |
Primary outcome
Participant Retention Rate
Time frame: Through completion of the 4-week intervention
Percentage of enrolled participants who completed the four-week intervention and the post-intervention assessment.
Attendance Rate
Time frame: Throughout the 4-week intervention
Percentage of scheduled intervention sessions attended by participants who completed the program.
Intervention Delivery
Time frame: Throughout the 4-week intervention
Proportion of the eight planned intervention sessions successfully delivered as scheduled.
Participant Satisfaction
Time frame: Immediately after completion of the 4-week intervention
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.
Willingness to Participate Again
Time frame: Immediately after completion of the 4-week intervention
Proportion of participants indicating willingness to participate in the active music program again.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Agustíin J Simonelli Muñoz, PhD principal investigator
Universidad de Almeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Active Music Program in people with Cognitive Impairment, run by Universidad de Almeria at 1 site in Spain.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 21 Sep 2026. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Retention Rate (time frame: Through completion of the 4-week intervention). 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?
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 21 Sep 2026.