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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
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
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 that have been studied so far have not used music streaming to generate playlists based on patient preferences, while incorporating recommended tempo and duration. It is important that a music intervention take into consideration the expertise of ICU patients, family members, and nursing staff. OBJECTIVE The primary objective of this study is 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 in patients able to self-report and those unable to self-report. METHODS A 6-month, single-blind 2x2 randomized crossover pilot trial will be used. Participating patients will undergo a 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. 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 also be collected on the feasibility of the intervention delivery and research methods throughout the study duration, and on pain intensity and distress before and after intervention delivery. RESULTS Recruitment and data collection began in March 2022 and are ongoing. CONCLUSIONS Methodological strengths and limitations are discussed. Limitations of this study include the lack of blinding for patients able to self-report. Strengths include the cross-over RCT design. CLINICALTRIAL ClinicalTrials.gov NCT05320224
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