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OpenTrials
Completed

NCT Number: NCT07581639

Comparison of Live and Virtual Music-based Interventions in Mitigating Stress

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.

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Key information

Conditions

Stress Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Conestoga High School

Berwyn, Pennsylvania, 19312, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Live Music Therapy

Behavioral

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.

Virtual Music Therapy

Behavioral

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.

Primary outcomes

  1. Self-reported stress levels

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

    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).

  2. Heart rate (HR)

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

    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.

  3. Systolic blood pressure

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

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Conestoga High School

Registry information

Official study title

Comparison of Live and Virtual Music-based Interventions in Mitigating Stress: A Pilot Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 12, 2026
Registry last updated
May 15, 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.

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