Recruiting

Music Intervention

Sponsor:

McGill University

Code:

NCT05320224

Conditions

Pain, Acute

Distress, Emotional

Critical Illness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patient-Oriented Music Intervention (POMI)

Study Details

Brief 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

Study ID

NCT05320224

Start date

Mar 15, 2022

Status verified date

Apr, 2022

Completion date

Sep 10, 2022

Anticipated

Primary completion date

Sep 10, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • ≥ 18 years old (all patients)
  • Admitted to ICU (all patients)
  • Able to self-report (patients able to self-report)
  • Able to listen to music as per patient (patients able to self-report)
  • Significant person is present at bedside (patients unable to self-report)
  • Considers self to have knowledge of the patient's music preferences (significant persons)
  • Is qualified to consent to any care required by the state of health for the incapable ICU adult patient (significant persons)
  • Is present during turning procedure at the time of the POMI project data collection (nurses/orderlies)

Exclusion criteria:

  • Cannot be turned (all patients)
  • Does not speak/understand French or English (all participants)
  • RASS -5 (all patients)
  • Under effects of neuromuscular blocking agents (all patients)

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Patient-Oriented Music Intervention (POMI) followed by No Music - Sequence AB

Patient participants will first receive 20-30 minutes of the patient-oriented music intervention (POMI) first, followed by no music, with a minimal washout period of four hours

other: No Music followed by Patient-Oriented Music Intervention (POMI) - Sequence BA

Patient participants will first receive no music first, followed by 20-30 minutes of the patient-oriented music intervention (POMI), with a minimal washout period of four hours

Interventions

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).

Primary outcome measure

  • Acceptability questionnaire, adapted from the validated Treatment Acceptability and Preferences questionnaire, 0-20 rating scores [ Time Frame: 60 minutes ]
  • Feasibility of intervention delivery [ Time Frame: up to 60 minutes ]

Central Contacts and Locations

Central contacts

Locations

Jewish General Hospital

Recruiting

Montréal, Quebec, Canada, H3T1E2

Contacts

More Information

Sponsor

McGill University

Last update posted

Apr 11, 2022

Last verified

Apr, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2022-04-11.