Music therapy during mechanical ventilation in the intensive care unit

INTERVENTION: 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 group. All patients signed informed consent. Blinding of data collection and data analysis is guaranteed. Due to the nature of the intervention (music therapy), blinding patients and music therapists is not possible. A maximum of four interventions (one intervention daily) will be carried out from the day of the signing of the informed consent until the fourth intervention or the first extubation of the participant. Duration of the intervention: between 25‐30 minutes. Intervention Group 1: Music‐Assisted Relaxation (MAR) MAR is a music therapy technique that includes listening to live music, combined with guided relaxation and/or the use of imagery. First, the patient is asked to close his/her eyes or focus on a fixed point on the ceiling or wall. Then a verbal introduction is given, focusing on generating body awareness. In the next step, a mental image is introduced (for example, sitting on a beach watching the waves of the ocean, imagining a personalized safe and comfortable place). The patient is then asked to let himself/herself be guided by the music while concentrating on the imagery. Once the music had finished, the patient is asked to become aware again. Intervention group 2: Patient‐preferred Therapeutic Music Listening (PTML) The use of pre‐recorded music is a frequent resource in both music therapy and music medicine interventions. In music therapy, listening to music is based on an initial assessment and patient preferences, and takes place in the context of a therapeutic relationship. In this sense, the music is shared between the patient and the music therapi CONDITION: Anxiety in patients receiving mechanical ventilation ; Mental and Behavioural Disorders PRIMARY OUTCOME: 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 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 SECONDARY OUTCOME: 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