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Effects of Music Therapy on Anxiety Symptoms in Patients With Prolonged Mechanical Ventilation: A Randomized Controlled Trial

24. april 2026 opdateret af: Shi Songqi, Capital Medical University

The purpose of this study is to evaluate the effects of music therapy on anxiety symptoms in patients requiring prolonged mechanical ventilation (PMV). PMV patients, defined as those ventilated for more than 21 days, often experience intense psychological stress and anxiety due to long-term intubation and the ICU environment. High anxiety can lead to "patient-ventilator asynchrony," which delays the weaning process.

In this study, 200 participants will be randomly assigned to either a control group receiving standard care or an experimental group receiving patient-directed music therapy. The music therapy intervention involves listening to selected music through noise-canceling headphones for 30 minutes, twice daily, over a 14-day period. The study will measure improvements in anxiety levels, pain, and sleep quality to determine if music therapy can help break the cycle of anxiety and facilitate recovery.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a prospective, single-blind, multi-center randomized controlled trial conducted at Beijing Rehabilitation Hospital and two collaborating medical institutions. Eligible participants are patients aged 50 or older who meet the diagnostic criteria for prolonged mechanical ventilation (ventilation duration ≥ 21 days for at least 6 hours per day).

Intervention Protocols:

Experimental Group: Participants will receive "Patient-Directed" music therapy in addition to standard ICU/rehabilitation care. A digital music library featuring classical, nature sounds, light pop, and traditional Chinese folk music (60-80 bpm) will be used. Music is delivered via medical-grade noise-canceling headphones at a volume of 60-70 decibels for 30 minutes, twice daily (10:00-11:00 and 15:00-16:00), for a total of 14 days.

Control Group: Participants will receive standard care and environmental control (noise and light management). To minimize bias, the interaction time between nursing staff and patients in the control group will be identical to that in the experimental group.

Outcome Measures:

Primary Outcome: Improvement in anxiety severity measured by the Visual Analog Scale for Anxiety (VAS-A) and the State-Trait Anxiety Inventory (STAI-S).

Secondary Outcomes: Pain levels assessed by the Critical-Care Pain Observation Tool (CPOT), sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), and successful extubation rates.

Statistical Analysis: Data will be analyzed using SPSS 26.0 and R 4.3. Linear Mixed Models (LMM) or Generalized Estimating Equations (GEE) will be employed to evaluate longitudinal changes across four time points: baseline (T0), day 3 (T1), day 7 (T2), and day 14 (T3).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Songqi Shi, Bachelor of Science
  • Telefonnummer: +86-18601258786
  • E-mail: 1499913759@qq.com

Undersøgelse Kontakt Backup

  • Navn: Hongying Jiang, Ph.D.
  • Telefonnummer: +86-10-56981067

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100144
        • Beijing Rehabilitation Hospital, Capital Medical University
        • Kontakt:
          • Songqi Shi, Bachelor of Science
          • Telefonnummer: +86-18601258786
          • E-mail: 1499913759@qq.com
        • Kontakt:
          • Hongying Jiang, Ph.D.
          • Telefonnummer: +86-10-56981067

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

- 1、Age > 50 years 2、Diagnosed with Prolonged Mechanical Ventilation (PMV), meeting the following criteria: Continuous mechanical ventilation for ≥ 21 days Daily mechanical ventilation duration ≥ 6 hours Ventilation via endotracheal tube, tracheostomy, or non-invasive interface (face/nasal mask).

3、Voluntarily signed the informed consent form (either by the patient or their legal representative).

Exclusion Criteria:

  • 1、Cognitive or psychiatric disorders: history of severe mental illness (e.g., schizophrenia, severe depression, bipolar disorder) or diagnosed moderate-to-severe dementia/cognitive impairment.

    2、Presence of delirium: assessed as positive by the Confusion Assessment Method for the ICU (CAM-ICU) prior to enrollment.

    3、Extreme hemodynamic instability: unstable vital signs requiring frequent resuscitation, or in the acute phase of a severe cardio-cerebrovascular accident.

    4、Untreated hearing impairment. 5、Physical conditions preventing safe earphone use (e.g., skin damage, burns, facial or cranial fractures).

    6、Poor prognosis: end-stage disease or assessed by the investigator as having a life expectancy insufficient to complete the intervention and follow-up period.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental: Music Therapy Group
Participants will receive patient-directed music therapy (PDMT) in addition to standard respiratory ICU/rehabilitation care and environmental control.
Andet: Patient-Directed Music Therapy (PDMT)

Music Selection: Patients or families select genres (classical, nature sounds, light pop, or traditional Chinese folk) with a tempo of 60-80 bpm.

Equipment: Medical-grade noise-canceling headphones. Dosage: 30 minutes per session, twice daily (10:00-11:00 and 15:00-16:00) for 14 consecutive days.

Volume: Limited to 60-70 decibels.

Andet: Environmental Control and Matched Interaction

Environmental Control: Minimizing noise and light interference in the ward, using silent earplugs and eyemasks when necessary.

Matched Interaction: Nursing staff will spend the same amount of bedside time with control group patients as they do with the music therapy group to ensure consistency in care-related interaction.
Aktiv komparator: Active Comparator: Control Group
Participants will receive standard respiratory ICU/rehabilitation care, including routine analgesia/sedation management, mechanical ventilation adjustment, and basic psychological support. They will also receive environmental control (noise and light management) and matched nurse bedside interaction time to control for the Hawthorne effect.
Andet: Environmental Control and Matched Interaction

Environmental Control: Minimizing noise and light interference in the ward, using silent earplugs and eyemasks when necessary.

Matched Interaction: Nursing staff will spend the same amount of bedside time with control group patients as they do with the music therapy group to ensure consistency in care-related interaction.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improvement in Anxiety Severity
Tidsramme: Change from Baseline (T0) to Day 14 of intervention (T3)
Measured by the Visual Analog Scale for Anxiety (VAS-A) and the State-Trait Anxiety Inventory-State (STAI-S) 。VAS-A is a 0-10 cm scale where higher scores indicate higher anxiety levels. STAI-S is a 20-item scale assessing current state anxiety 。
Change from Baseline (T0) to Day 14 of intervention (T3)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Severity
Tidsramme: Baseline (T0), Day 3 (T1), Day 7 (T2), and Day 14 (T3)
Assessed using the Critical-Care Pain Observation Tool (CPOT)
Baseline (T0), Day 3 (T1), Day 7 (T2), and Day 14 (T3)
Sleep Quality
Tidsramme: Baseline (T0) and Day 14 (T3)
Measured by the Pittsburgh Sleep Quality Index (PSQI)
Baseline (T0) and Day 14 (T3)
Successful Extubation Rate
Tidsramme: Up to Day 14 or discharge from ICU
The percentage of patients who successfully remain extubated for at least 48 hours without requiring re-intubation
Up to Day 14 or discharge from ICU

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Capital Medical University

Efterforskere

  • Studieleder: Hongying Jiang, Beijing Rehabilitation Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. maj 2027

Datoer for studieregistrering

Først indsendt

24. april 2026

Først indsendt, der opfyldte QC-kriterier

24. april 2026

Først opslået (Faktiske)

1. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026bkky-051

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

"Individual participant data will not be shared to protect participant privacy and maintain confidentiality, as stated in the study protocol and informed consent approved by the Ethics Committee."

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