Feasibility and Acceptability of a Patient-Oriented Music Intervention to Reduce Acute Pain in the Adult Intensive Care Unit: A Randomized Crossover Pilot Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain, Acute
- Sponsor
- McGill University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Acceptability questionnaire, adapted from the validated Treatment Acceptability and Preferences questionnaire, 0-20 rating scores
- Last Updated
- 4 years ago
Overview
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.
Investigators
Céline Gélinas
Full Professor, Senior Researcher
McGill University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Acceptability questionnaire, adapted from the validated Treatment Acceptability and Preferences questionnaire, 0-20 rating scores
Time Frame: 60 minutes
The acceptability questionnaire is adapted from the validated Treatment Acceptability and Preferences (TAP) questionnaire. The TAP and is comprised of four items: suitability, appropriateness, effectiveness and willingness to comply, each of which is rated on a 5-point scale ranging from 0 (not at all) to 4 (very much) for a total score ranging from 0 to 20, with higher scores indicating higher acceptability. The total scale score is obtained by calculating the mean of all the items' scores. The TAP can capture the complex nature of participants' preferences and yet be simple enough for use in the ICU setting. One item has been added to the questionnaire to determine the risks of side effects of the POMI, an additional important aspect in assessing the acceptability of the intervention.
Feasibility of intervention delivery
Time Frame: up to 60 minutes
The items for the assessment of the feasibility of intervention include time spent creating the individualized playlist, the presence or absence of any issue with headphone or pillow use, the presence or absence of any issue with music delivery, the presence or absence of skipping one or more song from the generated playlist, the presence or absence of any environmental noise, any POMI interruptions, whether the ICU adult patient participant received the full duration of the POMI, the dose (duration in minutes) of the music actually delivered, and the content of the music delivered (details of the music pieces played).
Secondary Outcomes
- Change from Baseline Pain distress on the 11-point Numeric Rating Scale (NRS) at 30 minutes(Baseline and 30 minutes)
- Change from Baseline Critical-Care Pain Observation Tool (CPOT) at 30 minutes(Baseline and 30 minutes)
- Change from Bed Turning Pain distress on the 11-point Numeric Rating Scale (NRS) at 30 minutes(From bed turning (up to 90 minutes post baseline) to 30 minutes post bed turning)
- Change from Baseline Critical-Care Pain Observation Tool (CPOT) at Bed Turning(From baseline to bed turning, up to 90 minutes)
- Change from Baseline Pain intensity on the 11-point Numeric Rating Scale (NRS) at 30 minutes(Baseline and 30 minutes)
- Change from Baseline Pain intensity on the 11-point Numeric Rating Scale (NRS) at Bed Turning(From baseline to bed turning, up to 90 minutes)
- Change from Baseline Pain distress on the 11-point Numeric Rating Scale (NRS) at Bed Turning(From baseline to bed turning, up to 90 minutes)
- Change from Bed Turning Pain intensity on the 11-point Numeric Rating Scale (NRS) at 30 minutes(From bed turning (up to 90 minutes post baseline) to 30 minutes post bed turning)
- Change from Bed Turning Critical-Care Pain Observation Tool (CPOT) at 30 minutes(From bed turning (up to 90 minutes post baseline) to 30 minutes post bed turning)