Music therapy during mechanical ventilation in the intensive care unit

Effect of MUsic Therapy on short-term psychological and physiological outcomes in Mechanically Ventilated patients: a randomized clinical pilot study (MUT-MV)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16964680

Enrollment

Registered

2023-07-05

Start date

2022-03-07

Completion date

Unknown

Last updated

2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety in patients receiving mechanical ventilation Mental and Behavioural Disorders

Interventions

This study is a single-site randomized controlled pilot study with three arms. Patients are randomized (1:1) using random numbers in Excel to intervention group 1, intervention group 2, or control gro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged older than 18 years 2. Mechanical ventilation hospitalized in the ICU 3. Alert and mentally competent (Richmond Agitation Sedation Scale between -1 and +1) 4. The expectation of being mechanically ventilated for more than 3 days from the moment of signing the informed consent

Exclusion criteria

Exclusion criteria: 1. Confirmed bilateral hearing loss 2. Delirium or disorders of consciousness 3. Known psychiatric disorders 4. Cognitive disabilities 5. Known addictions to psychoactive substances

Design outcomes

Primary

Measure	Time frame
Anxiety measure using the Spanish 6-item version of the State-trait Anxiety Inventory (STAI-E6) at baseline (after signing the informed consent) and after each intervention	—

Secondary

Measure	Time frame
1. Perceived pain intensity by the patient measured using a Visual Analogue Scale (VAS) from 0-10 at baseline (after signing the informed consent) and after each intervention 2. Resilience measured using the Brief Resilience Scale (BRS) containing 6 items rated on a 5-point Likert scale at baseline (after signing the informed consent) and after the second, third, and last intervention 3. Agitation/Delirum measured using the Confusion Assessment Method in the ICU (CAM-ICU) and Richmond Agitation Sedation Scale scale (RASS) at baseline (after signing the informed consent) and after each intervention 4. Vital signs including heart rate, respiratory rate, oxygen saturation, and blood pressure measured using routine patient monitoring before and after the intervention 5. Days of mechanical ventilation measured using patient records and calculated as follows: day of the first extubation – day of intubation = days of MV, at one timepoint 6. Extubation success including the number of failed extubations and/or necessary re-intubations measured using patient records at one timepoint 7. Days in the ICU measured using patient records, calculated as follows: date of discharge – date of admission = days in the ICU, at one timepoint	—

Measure

Time frame

1. Perceived pain intensity by the patient measured using a Visual Analogue Scale (VAS) from 0-10 at baseline (after signing the informed consent) and after each intervention 2. Resilience measured using the Brief Resilience Scale (BRS) containing 6 items rated on a 5-point Likert scale at baseline (after signing the informed consent) and after the second, third, and last intervention 3. Agitation/Delirum measured using the Confusion Assessment Method in the ICU (CAM-ICU) and Richmond Agitation Sedation Scale scale (RASS) at baseline (after signing the informed consent) and after each intervention 4. Vital signs including heart rate, respiratory rate, oxygen saturation, and blood pressure measured using routine patient monitoring before and after the intervention 5. Days of mechanical ventilation measured using patient records and calculated as follows: day of the first extubation – day of intubation = days of MV, at one timepoint 6. Extubation success including the number of failed extubations and/or necessary re-intubations measured using patient records at one timepoint 7. Days in the ICU measured using patient records, calculated as follows: date of discharge – date of admission = days in the ICU, at one timepoint

—

Countries

Colombia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026