Acceptability and Feasibility of a Patient-Oriented Music Intervention to Reduce Pain in the Intensive Care Unit: Protocol for a Crossover Pilot Randomized Controlled Trial
Authors: Richard-Lalonde Melissa , Feeley Nancy , Cossette Sylvie , Chlan Linda L , Gélinas Céline 
Published: March 2023

Background
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 studied so far have not used music streaming to generate playlists based on patient preferences while incorporating recommended tempo and duration. Previous research has focused on postoperative ICU patients able to self-report, which is underrepresentative of the ICU population that might benefit from a music intervention for pain management. We developed a new patient-oriented music intervention (POMI) that incorporates features based on theoretical, empirical, and experiential data intended to be used in the ICU. Such a music intervention should consider the expertise of ICU patients, family members, and nursing staff, as well as the practicality of the intervention when used in practice.

Objective
The primary objectives of this study are to (1) evaluate the acceptability and feasibility of the POMI to reduce pain in ICU patients and (2) evaluate the feasibility of conducting a crossover pilot 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.

Methods
A single-blind 2×2 crossover pilot RCT will be conducted. Patients will undergo 1 sequence of 2 interventions: the POMI which delivers music based on patients’ preferences via headphones or music pillow for 20-30 minutes and the control intervention (headphones or pillow without music). The sequence of the interventions will be inverted with a 4-hour washout period. Timing of the interventions will be before a planned bed turning procedure. Each patient will undergo 1 session of music. Twenty-four patients will be recruited. Patients able to self-report (n=12), family members of patients unable to self-report (n=12), and nursing staff (n=12) involved in the bed turning procedure will be invited to complete a short questionnaire on the POMI acceptability. Data will be collected on the feasibility of the intervention delivery (ie, time spent creating a playlist, any issue related to headphones/pillow or music delivery, environmental noises, and intervention interruptions) and research methods (ie, number of patients screened, recruited, randomized, and included in the analysis). Pain scores will be obtained before and after intervention delivery.

Results
Recruitment and data collection began in March 2022. As of July 5, 2022, in total, 22 patients, 12 family members, and 11 nurses were recruited.

Conclusions
Methodological limitations and strengths are discussed. Study limitations include the lack of blinding for patients able to self-report. Strengths include collecting data from various sources, getting a comprehensive evaluation of the intervention, and using a crossover pilot RCT design, where participants act as their own control, thus reducing confounding factors.

Trial Registration
ClinicalTrials.gov NCT05320224; https://clinicaltrials.gov/ct2/show/NCT05320224

International Registered Report Identifier (IRRID)
DERR1-10.2196/40760