- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07581639
Comparison of Live and Virtual Music-based Interventions in Mitigating Stress
12. mai 2026 oppdatert av: University of Pennsylvania
Comparison of Live and Virtual Music-based Interventions in Mitigating Stress: A Pilot Study
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
32
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Pennsylvania
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Berwyn, Pennsylvania, Forente stater, 19312
- Conestoga High School
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Live 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.
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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.
|
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Eksperimentell: Virtual music therapy
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.).
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Heart rate (HR)
Tidsramme: 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.
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Baseline (15 minutes before the music intervention session) and follow-up (15 minutes after the music intervention session was completed)
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Systolic blood pressure
Tidsramme: 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
|
Baseline (15 minutes before the music intervention session) and follow-up (15 minutes after the music intervention session was completed)
|
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Self-reported stress levels
Tidsramme: Baseline (15 minutes before the music intervention session) and follow-up (15 minutes after the music intervention session was completed)
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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).
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Baseline (15 minutes before the music intervention session) and follow-up (15 minutes after the music intervention session was completed)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. august 2025
Primær fullføring (Faktiske)
27. september 2025
Studiet fullført (Faktiske)
27. september 2025
Datoer for studieregistrering
Først innsendt
27. april 2026
Først innsendt som oppfylte QC-kriteriene
5. mai 2026
Først lagt ut (Faktiske)
12. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 01082025
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Informed consent to share individual participant data was not obtained.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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