Acceptability and Feasibility of a Patient-Oriented Music Intervention to Reduce Pain in the Intensive Care: Protocol for a Randomized Crossover Pilot Trial (Preprint)

Abstract

Many patients experience pain in the intensive care unit (ICU) despite receiving pain medication. Research has shown that music can help reduce pain. Music interventions that have been studied so far have not used music streaming to generate playlists based on patient preferences, while incorporating recommended tempo and duration. Previous research has mainly focused on postoperative ICU patients who are able to self-report, which is under representative of the mixed ICU population that might benefit from a music intervention as a complementary pain management. We developed a new music intervention that incorporates features based on theoretical, empirical, and experiential data, intended to be used in the ICU adult population. It is important that such a music intervention take into consideration the expertise of ICU patients, family members, and nursing staff, as well as the practicality of the intervention when it is used in practice.

The primary objectives of this study are to: a) evaluate the acceptability and feasibility of a new patient-oriented music intervention (POMI) to reduce pain in ICU patients, and b) evaluate the feasibility of conducting a crossover randomized controlled trial (RCT) for intervention testing in the ICU. A secondary objective is to examine the preliminary efficacy of the POMI to reduce pain in ICU patients able to self-report and those unable to self-report.

A 6-month, single-blind 2x2 randomized crossover pilot trial will be conducted. Participating patients will undergo one sequence of two interventions: the POMI which delivers music based on patients’ preferences via headphones or music pillow for 20-30 minutes and the control intervention (CTL: headphones/pillow without music). The sequence of the interventions will be inverted with a 4-hour washout period between the 2 interventions. Timing of the interventions will be prior to a planned bed turning procedure. Each patient participant will undergo one single session of music. Twenty-four patients (12 able to self-report their pain and 12 unable to self-report) will be recruited. Patients able to self-report, family members (n=12) of patients unable to self-report and nursing staff (n=12) involved in the bed turning procedure will be invited to complete a short questionnaire on the acceptability of the POMI. Data will be collected on the feasibility of the intervention delivery (i.e., time spent creating playlist, presence of any issue related to music delivery, environmental noises, intervention interruptions) and research methods (i.e., number of patients screened, recruited, randomized, included in analysis) throughout the study duration. Pain scores will be obtained before and after intervention delivery.

Recruitment and data collection began in March 2022.

Methodological limitations and strengths are discussed. Limitations of this study include the lack of blinding for patients able to self-report. Strengths include the collection of data from various sources, to get a more comprehensive evaluation of the intervention, and the use of a cross-over RCT design, where participants act as their own control, thus reducing confounding factors.

ClinicalTrials.gov NCT05320224