The acceptability and feasibility of a patient-oriented music intervention (POMI) for use in the adult intensive care unit: a crossover pilot randomized controlled trial

Abstract

Abstract Background Music is suggested as a complementary pain management intervention in the intensive care unit (ICU). However, evidence from interested parties on the acceptability and feasibility of music in the ICU is scarce. A patient-oriented music intervention (POMI) was developed using a music streaming service to generate individualized playlists within the recommended 60–80 beats/minute tempo. Our primary objectives were to evaluate the acceptability and feasibility of POMI among ICU patients, family, and nursing staff, and the feasibility of research methods. A secondary objective was to obtain exploratory estimates of the treatment effect of POMI on pain during turning in the ICU. Trial design Crossover pilot randomized controlled trial. Methods Three categories of participants were recruited: (a) ICU patients able to self-report ( n = 12) and unable to self-report ( n = 12); (b) family members ( n = 12) of patients unable to self-report; and (c) ICU nurses of recruited patients ( n = 12). Patients were randomized to either sequence 1 (POMI followed by control period), or sequence 2 (control followed by POMI period), with a 4-h washout period. The POMI period was administered for a minimal duration of 20 min before turning procedure. No music was administered during the control period. Outcomes included acceptability and feasibility of POMI (e.g., music duration), feasibility of research methods (e.g., eligibility rate), and pain scores. Pain was measured at four timepoints (T0: pre-intervention; T1: post-intervention; T2: during turning; T3: 30 min post-turning). Results Of the 347 patients screened, 53 (15%) were eligible for study enrollment and 24 (45%) consented to participate. Twelve patients (total n = 24) were randomized to each sequence (1 and 2). All participants evaluated the POMI to be acceptable. The POMI was feasible for over 80% of patients although turning occurred 7–111 min after starting POMI making the timing of the intervention challenging. Median pain scores were lower after the POMI period than after the control period. These estimates are exploratory and do not establish efficacy. Conclusion Flexible durations of POMI should be applied due to unpredictable timing of turning. Eligibility rate was limited due to the low proportion of eligible candidates. Further research is warranted to determine POMI efficacy to reduce pain in ICU patients. Trial registration Clinicaltrials.gov: NCT05320224, registered 8 March 2022, https://clinicaltrials.gov/study/NCT05320224 .