Skip to main content
OpenTrials
Completed

NCT Number: NCT07831850

Nurse-Led Active Music Program in Older Adults With Cognitive Impairment

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virgen del Rosario Long-Term Care Residence

Roquetas de Mar, Almería, 04740, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Nurse-Led Active Music Program

Behavioral

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.

Primary outcomes

  1. 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.

  2. Attendance Rate

    Time frame: Throughout the 4-week intervention

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

  3. Intervention Delivery

    Time frame: Throughout the 4-week intervention

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

  4. 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.

  5. 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.

Other outcomes

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

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

    Cognitive function was assessed using the Spanish version of the Montreal Cognitive Assessment (MoCA). Total scores range from 0 to 30, with higher scores indicating better global cognitive performance. Change was assessed by comparing baseline and post-intervention scores.

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

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

    Depressive symptoms were assessed using the 15-item Geriatric Depression Scale (GDS-15). Total scores range from 0 to 15, with higher scores indicating a greater burden of depressive symptoms. Change was assessed by comparing baseline and post-intervention scores.

  3. Active Participation During Intervention Sessions

    Time frame: During each of the 8 intervention sessions over 4 weeks

    Active participation was assessed during each of the eight intervention sessions using a structured observational record developed for the study. Participants were rated on a 5-point ordinal scale, with higher scores indicating greater involvement in singing, rhythmic, and movement activities. Mean scores across attended sessions were calculated for each participant.

  4. Sustained Attention During Intervention Sessions

    Time frame: During each of the 8 intervention sessions over 4 weeks

    Sustained attention was assessed during each of the eight intervention sessions using a structured observational record developed for the study. Participants were rated on a 5-point ordinal scale, with higher scores indicating a greater ability to remain engaged with the facilitator's instructions and session activities. Mean scores across attended sessions were calculated for each participant.

  5. Social Interaction During Intervention Sessions

    Time frame: During each of the 8 intervention sessions over 4 weeks

    Social interaction was assessed during each of the eight intervention sessions using a structured observational record developed for the study. Participants were rated on a 5-point ordinal scale, with higher scores indicating greater verbal or non-verbal communication with other participants or with the facilitator. Mean scores across attended sessions were calculated for each participant.

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.