NCT05320224

Feasibility & Acceptability of a Patient-Oriented Music Intervention to Reduce Pain in the Intensive Care: A Pilot Trial

Feasibility and Acceptability of a Patient-Oriented Music Intervention to Reduce Acute Pain in the Adult Intensive Care Unit: A Randomized Crossover Pilot Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: McGill University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Introduction Many patients experience pain in the intensive care unit (ICU) despite receiving pain medication. Research has shown that music can help manage pain. Music interventions that have been studied so far have not been based on patient preferences, recommended tempo and duration, nor used music streaming. It is important that a music intervention take into consideration the expertise of ICU patients, family members and nurses/orderlies. Study objectives This study aims to evaluate the feasibility and acceptability of a new patient-oriented music intervention (POMI) to reduce pain in ICU patients. In addition, the aim is to evaluate the feasibility of conducting a crossover randomized controlled trial (RCT) to test the interventions in the adult ICU. A secondary objective will be to examine the preliminary efficacy of the POMI. Methodology/Study Design A single-blind 2x2 crossover pilot RCT will be used to evaluate the feasibility, acceptability, and preliminary efficacy of the POMI. Patients will undergo a sequence of two intervention periods: the POMI and the Active Control intervention (ACI; headphones/pillow without music). Patients will be randomly assigned to Sequence 1 or Sequence 2, where patients in Sequence 1 receive the POMI during the first intervention period, followed by the ACI in the second intervention period; and patients in Sequence 2 receive the ACI first, followed be the POMI (with a 4-hour washout period). Before the turning procedure, music will be stopped, and the headphones will be removed. For patients able to self-report, the music (or control period without music) will be delivered either via headphones or a music pillow, depending on their individual preference. For patients unable to self-report, music (or control period without music) will be delivered via the music pillow. Twenty-four patients (12 patients able to self-report their pain and 12 patients unable to self-report) will be recruited. The 12 patients able to self-report will be asked about their music preferences and to complete an acceptability questionnaire (AQ). For the 12 patients unable to self-report, 12 family members will be recruited to answer questions on the patient's music preferences and to complete an AQ. In addition, 12 nurses/orderlies (involved in the turning procedure for a patient participant) will be recruited and asked to complete an AQ.

Conditions

• Pain, Acute
• Distress, Emotional
• Critical Illness

Interventions

Type	Name	Description
OTHER	Patient-Oriented Music Intervention (POMI)	The brief name given to this intervention is POMI (Patient-Oriented Music Intervention). In POMI, music is delivered to adult patients either via headphones (Bose) or by music pillow (MusiCure). Adults admitted to the intensive care unit (ICU) will choose the mode of delivery. ICU adult patients who are unable to self-report will hear music via music pillow. Individualized playlists will be created based on the patient music preferences, as self-reported. For patients unable to self-report, a person significant to the patient such as a family member will be asked about the patient music preferences. Questions about preferences will include music genre, track, artist, instrumentalness, acousticness, energy, and valence, as defined by the streaming service Spotify. A POMI web-based tool (https://pomi.glitch.me) will use these preferences to create personalized playlists on Spotify, with a tempo restriction of 60-80 bpm. Music will play for at least 20 minutes, via smart device (iPad).

Timeline

• Start date: 2022-03-15
• Primary completion: 2022-09-10
• Completion: 2022-09-10
• First posted: 2022-04-11
• Last updated: 2022-04-11

Locations

1 site across 1 country: Canada