Pain, AcutePOMI_PhaseIINCT05320224
Feasibility & Acceptability of a Patient-Oriented Music Intervention to Reduce Pain in the Intensive Care: A Pilot Trial
A study testing Patient-Oriented Music Intervention (POMI) in people with Pain, Acute and Distress, Emotional, run by McGill University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute, Distress, Emotional, Critical Illness
- What is being tested?
- Patient-Oriented Music Intervention (POMI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2022to 10 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Melissa Richard-Lalonde, Phd(c) contact
Canada1 site, 1 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T1E2
Melissa Richard-Lalonde, 514-340-8222 ext. 23641, melissa.richard-lalonde@mail.mcgill.ca
About this study
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
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.
Read more
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
- Being tested
- Patient-Oriented Music Intervention (POMI)
- Medical subject headings
- Acute Pain, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Patient-Oriented Music Intervention (POMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: up to 60 minutes
Secondary outcomes (9)
Change from Baseline Pain intensity on the 11-point Numeric Rating Scale (NRS) at 30 minutes
The Faces Pain Thermometer (FPT) is a 0-10 NRS with faces in a thermometer format allowing the measurement of self-reported pain intensity by patients. The FPT is advantageous for use in ICU adult patients not only for its concomitant use of faces with 0-10 number, but also for being presented vertically, facilitating the interpretation of the scale in adults of all ages. The FPT is reported to have acceptable test-retest reliability (Pearson's r, 0.63), high content validation (content validity indices, 0.73-1.00), high convergent validation with the descriptive pain scale (kappa coefficients ranging from 0.63-0.79) as well as discriminative validation, with significantly higher pain scores during nociceptive/painful events compared to non-nociceptive/non-painful events
Measured: Baseline and 30 minutes
Change from Baseline Pain intensity on the 11-point Numeric Rating Scale (NRS) at Bed Turning
The Faces Pain Thermometer (FPT) is a 0-10 NRS with faces in a thermometer format allowing the measurement of self-reported pain intensity by patients. The FPT is advantageous for use in ICU adult patients not only for its concomitant use of faces with 0-10 number, but also for being presented vertically, facilitating the interpretation of the scale in adults of all ages. The FPT is reported to have acceptable test-retest reliability (Pearson's r, 0.63), high content validation (content validity indices, 0.73-1.00), high convergent validation with the descriptive pain scale (kappa coefficients ranging from 0.63-0.79) as well as discriminative validation, with significantly higher pain scores during nociceptive/painful events compared to non-nociceptive/non-painful events
Measured: 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
The Faces Pain Thermometer (FPT) is a 0-10 NRS with faces in a thermometer format allowing the measurement of self-reported pain intensity by patients. The FPT is advantageous for use in ICU adult patients not only for its concomitant use of faces with 0-10 number, but also for being presented vertically, facilitating the interpretation of the scale in adults of all ages. The FPT is reported to have acceptable test-retest reliability (Pearson's r, 0.63), high content validation (content validity indices, 0.73-1.00), high convergent validation with the descriptive pain scale (kappa coefficients ranging from 0.63-0.79) as well as discriminative validation, with significantly higher pain scores during nociceptive/painful events compared to non-nociceptive/non-painful events
Measured: 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
Evaluation of the affective dimension of pain will be conducted using the validated a 0-10 pain distress score, derived from the NRS, ranging from no distress (0) to very distressing (10). In a study conducted with 3851 patients across 28 countries across 192 adult ICUs, higher degrees of pain distress were associated with turning procedures (relative risk = 1.18) and turning procedures predicted greater pain distress than pain intensity (odds ratio = 0.626).
Measured: Baseline and 30 minutes
Change from Baseline Pain distress on the 11-point Numeric Rating Scale (NRS) at Bed Turning
Evaluation of the affective dimension of pain will be conducted using the validated a 0-10 pain distress score, derived from the NRS, ranging from no distress (0) to very distressing (10). In a study conducted with 3851 patients across 28 countries across 192 adult ICUs, higher degrees of pain distress were associated with turning procedures (relative risk = 1.18) and turning procedures predicted greater pain distress than pain intensity (odds ratio = 0.626).
Measured: From baseline to bed turning, up to 90 minutes
Change from Bed Turning Pain distress on the 11-point Numeric Rating Scale (NRS) at 30 minutes
Evaluation of the affective dimension of pain will be conducted using the validated a 0-10 pain distress score, derived from the NRS, ranging from no distress (0) to very distressing (10). In a study conducted with 3851 patients across 28 countries across 192 adult ICUs, higher degrees of pain distress were associated with turning procedures (relative risk = 1.18) and turning procedures predicted greater pain distress than pain intensity (odds ratio = 0.626).
Measured: 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 30 minutes
Evaluation of pain using the CPOT yields a score between zero and eight with scores above 2 representing the presence of pain. More specifically, the CPOT includes 4 items that can each be scored from 0-2: facial expression, body movements, muscle tension and vocalization/ventilator compliance. The CPOT has been validated in 47 studies with 3966 ICU patients unable to self-report across 21 different countries. Interrater reliability was examined in 30 studies, as determined by intra-class correlation and/or weighted kappa values above 0.60. Discriminative validation has been consistently supported with significantly higher CPOT scores during nociceptive/painful events compared to rest periods of rest or non-nociceptive/non-painful events, as evaluated by all studies that measured it (n = 43).
Measured: Baseline and 30 minutes
Change from Baseline Critical-Care Pain Observation Tool (CPOT) at Bed Turning
Evaluation of pain using the CPOT yields a score between zero and eight with scores above 2 representing the presence of pain. More specifically, the CPOT includes 4 items that can each be scored from 0-2: facial expression, body movements, muscle tension and vocalization/ventilator compliance. The CPOT has been validated in 47 studies with 3966 ICU patients unable to self-report across 21 different countries. Interrater reliability was examined in 30 studies, as determined by intra-class correlation and/or weighted kappa values above 0.60. Discriminative validation has been consistently supported with significantly higher CPOT scores during nociceptive/painful events compared to rest periods of rest or non-nociceptive/non-painful events, as evaluated by all studies that measured it (n = 43).
Measured: From baseline to bed turning, up to 90 minutes
Change from Bed Turning Critical-Care Pain Observation Tool (CPOT) at 30 minutes
Evaluation of pain using the CPOT yields a score between zero and eight with scores above 2 representing the presence of pain. More specifically, the CPOT includes 4 items that can each be scored from 0-2: facial expression, body movements, muscle tension and vocalization/ventilator compliance. The CPOT has been validated in 47 studies with 3966 ICU patients unable to self-report across 21 different countries. Interrater reliability was examined in 30 studies, as determined by intra-class correlation and/or weighted kappa values above 0.60. Discriminative validation has been consistently supported with significantly higher CPOT scores during nociceptive/painful events compared to rest periods of rest or non-nociceptive/non-painful events, as evaluated by all studies that measured it (n = 43).
Measured: From bed turning (up to 90 minutes post baseline) to 30 minutes post bed turning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start15 Mar 2022
- Primary completion10 Sep 2022 (estimated)
- Study completion10 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Céline Gélinas, McGill University
- Investigators
- Céline Gélinas, RN, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320224
- Sponsor's protocol ID
- POMI_Phase_II_2022_3005
- Acronym
- POMI_PhaseII
- Status last verified
- Apr 2022
- First submitted
- 10 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37163350
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05320224
- Acronym / sponsor ID
- POMI_PhaseII / POMI_Phase_II_2022_3005
- Conditions
- Pain, Acute, Distress, Emotional, Critical Illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 10 Sep 2022 (estimated)
- Study completion
- 10 Sep 2022 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-Oriented Music Intervention (POMI) followed by No Music - Sequence AB | Other | Other: Patient-Oriented Music Intervention (POMI)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 |
| No Music followed by Patient-Oriented Music Intervention (POMI) - Sequence BA | Other | Other: Patient-Oriented Music Intervention (POMI)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | No Music followed by Patient-Oriented Music Intervention (POMI) - Sequence BA, Patient-Oriented Music Intervention (POMI) followed by No Music - Sequence AB |
Primary outcome
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).
9 secondary outcomes
Change from Baseline Pain intensity on the 11-point Numeric Rating Scale (NRS) at 30 minutes
Time frame: Baseline and 30 minutes
Change from Baseline Pain intensity on the 11-point Numeric Rating Scale (NRS) at Bed Turning
Time frame: 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
Time frame: 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
Time frame: Baseline and 30 minutes
Change from Baseline Pain distress on the 11-point Numeric Rating Scale (NRS) at Bed Turning
Time frame: From baseline to bed turning, up to 90 minutes
Change from Bed Turning Pain distress on the 11-point Numeric Rating Scale (NRS) at 30 minutes
Time frame: 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 30 minutes
Time frame: Baseline and 30 minutes
Change from Baseline Critical-Care Pain Observation Tool (CPOT) at Bed Turning
Time frame: From baseline to bed turning, up to 90 minutes
Change from Bed Turning Critical-Care Pain Observation Tool (CPOT) at 30 minutes
Time frame: From bed turning (up to 90 minutes post baseline) to 30 minutes post bed turning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Derived from this study: PubMed 37163350Richard-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Richard-Lalonde, Phd(c) contact
Céline Gélinas, RN, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Oriented Music Intervention (POMI) in people with Pain, Acute and Distress, Emotional, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa Richard-Lalonde, Phd(c) (514-340-8222 ext. 23641, melissa.richard-lalonde@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability questionnaire, adapted from the validated Treatment Acceptability and Preferences questionnaire, 0-20 rating scores (time frame: 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05320224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.