Generalized music therapy to reduce neuroactive drug needs in critically ill patients. Study protocol for a randomized trial.

BACKGROUND: Critically ill patients are exposed to several physical and emotional stressors, needing analgesic and sedative drugs to tolerate invasive procedures and the harsh intensive care unit (ICU) environment. However, this pharmacological therapy presents several side effects: guidelines suggest using a light sedation target, keeping critically ill patients calm, conscious, and cooperative. Personalized music therapy (MT) can reduce stress and anxiety, decreasing the need for drugs. The aim of the current investigation is to compare different approaches for MT in the ICU: a personalized approach, with music selected by patients/families and listened through headphones, or a generalized approach, with ambient music chosen by a music therapist and transmitted through speakers. PRIMARY OUTCOME: number of days "free from neuroactive drugs" in the first 28 days after ICU admission. SECONDARY OUTCOMES: total amount of neuroactive drugs (midazolam, propofol, morphine, fentanyl, haloperidol), stress during ICU stay (sleep at night, anxiety and agitation, use of physical restraints, stressors evaluated at discharge), the feasibility of generalized MT (interruptions requested by staff members and patients/families). METHODS: Randomized, controlled trial with three groups of critically ill adults: a control group, without MT; a personalized MT group, with music for at least 2 h per day; a generalized MT group, with music for 12.5 h/day, subdivided into fifteen 50-min periods. DISCUSSION: One hundred fifty-three patients are expected to be enrolled. This publication presents the rationale and the study methods, particularly the strategies used to build the generalized MT playlist. From a preliminary analysis, generalized MT seems feasible in the ICU and is positively received by staff members, critically ill patients, and families. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03280329. September 12, 2017.

Cultivating Empathy and Soft Skills Among Intensive Care Residents: Effects of a Mandatory, Simulation-Based, Experiential Training.

BACKGROUND Communication with families is crucial in ICU care. However, only a few residency programs include communication and relationship training in their curricula. This study aimed to assess the impact of a communication-skill course on residents' empathy and self-reported skills. MATERIAL AND METHODS A single-center, observational study was conducted. Since 2017, the 4th-year residents of the Anaesthesia and Intensive Care School, University of Milan attended the mandatory "Program to Enhance Relational and Communication Skills in ICU (PERCS-ICU)". PERCS-ICU lasted 10 hours and involved small groups of residents. The course was articulated around the simulation and debriefing of 3 difficult conversations with trained actors. Before and after the course, residents completed the Jefferson Scale of Empathy and a questionnaire measuring self-assessed preparation, communication skills, relational skills, confidence, anxiety, emotional awareness, management of emotions, and self-reflection when conducting difficult conversations. The quality and usefulness of the course and the case scenario were assessed on a 5-point Likert scales. RESULTS Between 2017 and 2019, 6 PERCS-ICU courses were offered to 71 residents, 69 of whom completed the questionnaires. After the course, residents reported improvements in empathy (p<.05), preparation (p<.001), communication skills (p<.005), confidence (p<.001), self-reflection (p<.001), and emotional awareness (p<.001). Residents perceived the course as very useful (mean=4.79) and high-quality (mean=4.58). The case scenario appeared very realistic (mean=4.83) and extremely useful (mean=4.91). All residents recommended the course to other colleagues. CONCLUSIONS PERCS-ICU proved to be a well-received and effective course to improve residents' empathy and some self-reported skills. The long-term effects remain to be investigated.

The PKU & ME study: A qualitative exploration, through co-creative sessions, of attitudes and experience of the disease among adults with phenylketonuria in Italy.

BACKGROUND: Phenylketonuria (PKU) is a hereditary metabolic disease that can be diagnosed and successfully treated from birth with a lifelong phenylalanine-restricted dietary regimen. However, optimal adherence to diet remains an issue and often progressively decreases after adolescence. The study aimed to explore the experience of adults living with PKU in order to gain insights related to their adherence to diet and engagement in managing their condition. METHODS: The study adopted a qualitative methodology in sessions that combined specifically designed co-creation exercises with focus group discussion. Adults with early-treated classic PKU were enrolled for 2 different sessions - one for adherent and one for non-adherent patients. The verbatim notes of both sessions and focus group were analyzed using content analysis. RESULTS: Twelve adherent and nine non-adherent adults with PKU participated. Besides the behavioral dictates of following a strict diet, adherent adults reported a positive mental approach and organizational rigor; they seemed aware of the consequences of high-phenylalanine levels, reporting that it can affect mood and consequently social interactions which they value highly. In the non-adherent group, the individuals seemed to not fully accept their disease: they were aware of the consequences of non-adherence in children but not in adults, they felt the management of PKU was an individual burden and they experienced a feeling of 'diversity' in the social context (related to eating) that caused emotional distress. PKU seemed a very influential element of the identity both for adherent and non-adherent adults, but with different consequences for the two groups. Finally, all participants reported the desire to be assisted in a healthcare setting dedicated to adults. CONCLUSIONS: The findings expand the understanding of the psychological experience of adult patients with PKU in relation to their disease and its dietary requirements, highlighting specific factors that might drive tailored educational or psychological intervention to improve adherence and engagement in the care process.