Clinical trial NCT05320224: Feasibility & Acceptability of a Patient-Oriented Music Intervention to Reduce Pain in the Intensive Care: A Pilot Trial
Official title: Feasibility and Acceptability of a Patient-Oriented Music Intervention to Reduce Acute Pain in the Adult Intensive Care Unit: A Randomized Crossover Pilot Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Acute
Distress, Emotional
Critical Illness
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Acceptability questionnaire, adapted from the validated Treatment Acceptability and Preferences questionnaire, 0-20 rating scores
timeFrame: 60 minutes
measure: Feasibility of intervention delivery
timeFrame: up to 60 minutes
Secondary outcomes:
measure: Change from Baseline Pain intensity on the 11-point Numeric Rating Scale (NRS) at 30 minutes
timeFrame: Baseline and 30 minutes
measure: Change from Baseline Pain intensity on the 11-point Numeric Rating Scale (NRS) at Bed Turning
timeFrame: From baseline to bed turning, up to 90 minutes
measure: Change from Bed Turning Pain intensity on the 11-point Numeric Rating Scale (NRS) at 30 minutes
timeFrame: From bed turning (up to 90 minutes post baseline) to 30 minutes post bed turning
measure: Change from Baseline Pain distress on the 11-point Numeric Rating Scale (NRS) at 30 minutes
timeFrame: Baseline and 30 minutes
measure: Change from Baseline Pain distress on the 11-point Numeric Rating Scale (NRS) at Bed Turning
timeFrame: From baseline to bed turning, up to 90 minutes
measure: Change from Bed Turning Pain distress on the 11-point Numeric Rating Scale (NRS) at 30 minutes
timeFrame: From bed turning (up to 90 minutes post baseline) to 30 minutes post bed turning
measure: Change from Baseline Critical-Care Pain Observation Tool (CPOT) at 30 minutes
timeFrame: Baseline and 30 minutes
measure: Change from Baseline Critical-Care Pain Observation Tool (CPOT) at Bed Turning
timeFrame: From baseline to bed turning, up to 90 minutes
measure: Change from Bed Turning Critical-Care Pain Observation Tool (CPOT) at 30 minutes
timeFrame: From bed turning (up to 90 minutes post baseline) to 30 minutes post bed turning
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: McGill University
name: Céline Gélinas, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: