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

NCT05320224 | Unknown

• 1 other identifier: POMI_Phase_II_2022_3005
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Acceptability questionnaire, adapted from the validated Treatment Acceptability and Preferences questionnaire, 0-20 rating scores

  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.

  60 minutes

• Feasibility of intervention delivery

  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).

  up to 60 minutes

Secondary Outcomes (9)

• 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 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 Baseline Pain distress on the 11-point Numeric Rating Scale (NRS) at 30 minutes

  Baseline and 30 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

Study Arms (2)

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

OTHER

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: Patient-Oriented Music Intervention (POMI)

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

OTHER

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

Other: Patient-Oriented Music Intervention (POMI)

Interventions

Patient-Oriented Music Intervention (POMI) OTHER

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).

No Music followed by Patient-Oriented Music Intervention (POMI) - Sequence BA; Patient-Oriented Music Intervention (POMI) followed by No Music - Sequence AB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

RECRUITING

Related Publications (1)

• Richard-Lalonde M, Feeley N, Cossette S, Chlan LL, Gelinas C. Acceptability and Feasibility of a Patient-Oriented Music Intervention to Reduce Pain in the Intensive Care Unit: Protocol for a Crossover Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 May 10;12:e40760. doi: 10.2196/40760.

  PMID: 37163350 DERIVED

MeSH Terms

Conditions

Acute Pain; Critical Illness

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Céline Gélinas, RN, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Richard-Lalonde, Phd(c)

CONTACT

514-340-8222; melissa.richard-lalonde@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Senior Researcher

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: April 11, 2022
• Study Start: March 15, 2022
• Primary Completion: September 10, 2022
• Study Completion: September 10, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Locations

CA (1)