NCT07581639

Brief Summary

The purpose of this study is to learn if virtual music therapy with active engagement components leads to the same benefits as traditional live music therapy in mitigating stress in older adults. This study aims to compare live and virtual music interventions among older adults with cognitive impairment living in assisted living facilities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

April 27, 2026

Last Update Submit

May 12, 2026

Conditions

Keywords

Comparison of virtual versus live music therapy

Outcome Measures

Primary Outcomes (3)

  • Self-reported stress levels

    The self-reported stress survey was adapted and modified from Levenstein et al. (1993), with question wording modified to reduce the reading level. The stress-assessment survey was condensed to a total of 10 questions, each rated on a 4-level Likert scale from strongly disagree (0) to strongly agree (3). To maintain consistency, the rating on 4 items indicating lack of stress was reversed, so that 0 corresponded to 3 points. The total score was calculated by adding the individual scores for each question (score range, 0 to 30, where a higher rating corresponds to greater stress).

    Baseline (15 minutes before the music intervention session) and follow-up (15 minutes after the music intervention session was completed)

  • Heart rate (HR)

    Registered nurses at each assisted living facility measured and recorded each participant's heart rate (HR) using an oxygen saturation monitor (Oxiline, Inc.). The monitor was placed on each participants' finger and the heart rate was recorded for a 1-minute interval 15 minutes before and after each music-based session.

    Baseline (15 minutes before the music intervention session) and follow-up (15 minutes after the music intervention session was completed)

  • Systolic blood pressure

    Systolic blood pressure was measured using a sphygmomanometer (Curaplex, Inc.) immediately after the heart rate measurement

    Baseline (15 minutes before the music intervention session) and follow-up (15 minutes after the music intervention session was completed)

Study Arms (2)

Live music therapy

ACTIVE COMPARATOR

The live music intervention was presented in the activities room of each senior center and included a classical violin for the performer (a classically trained violinist with experience arranging and playing pop music), a second violin for participant engagement, and a computer speaker for digital sound output (Dell, Inc.). The live music intervention sessions included multiple active engagement components, such as music adjustment (e.g., lowering the tempo, changing to an upbeat piece) to match participants' apparent mood, verbal interaction, physical engagement (e.g., encouraging dancing, on-beat clapping), and singing along.

Behavioral: Live music therapy

Virtual music therapy

EXPERIMENTAL

The virtual intervention followed identical procedures as the live intervention and involved similar active engagement components, with the music being delivered to the same cohort via video conference (Zoom Communications, Inc.).

Behavioral: Virtual music therapy

Interventions

The virtual intervention followed identical procedures as the live intervention and involved similar active engagement components, with the music being delivered to the same cohort via video conference (Zoom Communications, Inc.). In both live and virtual sessions, the performer showed identical levels of engagement and adjustment.

Virtual music therapy

The live music intervention was presented in the activities room of each senior center and included a classical violin for the performer (a classically trained violinist with experience arranging and playing pop music), a second violin for participant engagement, and a computer speaker for digital sound output (Dell, Inc.). The live music intervention sessions included multiple active engagement components, such as music adjustment (e.g., lowering the tempo, changing to an upbeat piece) to match participants' apparent mood, verbal interaction, physical engagement (e.g., encouraging dancing, on-beat clapping), and singing along.

Live music therapy

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Lives in included assisted living facility
  • years or older
  • Able to provide informed consent
  • Able to hear music
  • Able to see a computer screen
  • Able to speak

You may not qualify if:

  • Does not live in included assisted living facility
  • Younger than 65 years
  • Unable to provide informed consent
  • Unable to hear music
  • Unable to see a computer screen
  • Unable to speak

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Conestoga High School

Berwyn, Pennsylvania, 19312, United States

Location

MeSH Terms

Conditions

DementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 12, 2026

Study Start

August 1, 2025

Primary Completion

September 27, 2025

Study Completion

September 27, 2025

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Informed consent to share individual participant data was not obtained.

Locations