PainMUSICUNCT06174662
The Effect of Music on Procedural Distress During Mobilization in Intensive Care Unit Patients: A Randomized Controlled Trial
A study testing Music in people with Pain and Stress, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
This intervention study will investigate the effects of music therapy on procedural distress, the overall experience of pain, anxiety, and stress, during the procedure of sitting up in a chair for patients admitted to the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Music
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Feb 2024to 31 May 2025
- 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
- They are admitted to the ICU
- They have a Richmond Agitation-Sedation Scale (RASS) score of +1, 0, or -1
- They are able to speak Dutch
Who cannot join
- They are younger than 18 years old
- They have a hearing impairment
- They are in isolation
- They have a cranial dressing or intracranial pressure monitoring
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University of Antwerp
Wilrijk, Antwerp, 2610
Filip Haegdorens, PhD, 0032497769040, filip.haegdorens@uantwerpen.be
About this study
This intervention study will investigate the effects of music therapy on procedural distress, the overall experience of pain, anxiety, and stress, during the procedure of sitting up in a chair for patients admitted to the intensive care unit (ICU).
Read the detailed description
There is a paucity of literature on the use of music therapy ('music care') in intensive care units (ICUs) during the process of mobilization. However, research suggests that mobilization can reduce the risk of depression and improve cognitive function (Chiang et al., 2006). This study aims to investigate the impact of music therapy on procedural comfort during sit-to-stand mobilization in ICU patients.
Specifically, the investigators seek to examine the effects of music therapy on pain perception, stress levels, anxiety levels, and vital parameters (blood pressure, heart rate, and respiratory rate) during this procedure. The investigators hypothesize that music therapy can improve procedural comfort by reducing pain, stress, and anxiety.
This study employs quantitative multicenter research, specifically a randomized controlled trial (RCT), involving ICU patients at three hospitals: AZ Monica Deurne, GZA campus Sint-Augustinus, and Sint-Vincentius.
During the intervention, patients will listen to their preferred music through noise-canceling headphones. Patients will be able to select their preferred music.
To assess the effects of music therapy, the investigators developed a self-designed measurement tool, validated using content validation indices (CVI) with an expert panel including pain nurses. The tool measures various indicators, including:
Vital parameters: (arterial) blood pressure, heart rate, and respiratory rate
Pain perception: Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's pain level. Zero indicates no pain, while 10 represents the worst imaginable pain.
Anxiety and stress levels: Nurses will utilize 11-point Likert scales from 0 to 10 to measure the patient's anxiety and stress levels. The sum of these three scores will provide an overall measure of procedural distress.
To assess the duration of the effects of music therapy, we will record the above indicators at four time points:
Time 0: Ten minutes before sit-to-stand mobilization begins
Time 1: Ten minutes after sit-to-stand mobilization is completed
Time 2: Immediately before returning the patient to bed, after music stops
Time 3: Ten minutes after the patient is back in bed
Delta calculations will be performed to measure changes between time points.
The selected music playlist will be briefly noted on the measurement tool, and a final Likert scale will assess patient satisfaction with the intervention.
- Being tested
- Music
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicDevice
The patient can decide the music genre (a standard playlist) and receives a noise-cancelling headphone playing the chosen music during mobilization.
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Music through noise cancelling headphones. Receives: Device: Music |
| No music | No intervention | Control group receiving regular care. No music will be offered to the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain perception level
Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's pain level
Measured: Ten minutes before mobilization begins and ten minutes after mobilization is completed
stress perception level
Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's stress level.
Measured: Ten minutes before mobilization begins and ten minutes after mobilization is completed
anxiety perception level
Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's anxiety level.
Measured: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Secondary outcomes (4)
Time of mobilization
Time in minutes of mobilization
Measured: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Blood pressure
Systolic Blood Pressure
Measured: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Heart rate
Heart frequency per minute
Measured: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Respiratory frequency
Respiratory frequency per minute
Measured: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start2 Feb 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial (RCT) with parallel arms: control and intervention group. Not blinded.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Haegdorens, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174662
- Sponsor's protocol ID
- MUSICU
- Acronym
- MUSICU
- Status last verified
- Jul 2024
- First submitted
- 8 Dec 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can be shared on request
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Procedural Distress During Mobilization in Intensive Care Unit Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06174662
- Acronym / sponsor ID
- MUSICU / MUSICU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 18 Dec 2023 (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.
This intervention study will investigate the effects of music therapy on procedural distress, the overall experience of pain, anxiety, and stress, during the procedure of sitting up in a chair for patients admitted to the intensive care unit (ICU).
Detailed description
There is a paucity of literature on the use of music therapy ('music care') in intensive care units (ICUs) during the process of mobilization. However, research suggests that mobilization can reduce the risk of depression and improve cognitive function (Chiang et al., 2006). This study aims to investigate the impact of music therapy on procedural comfort during sit-to-stand mobilization in ICU patients.
Specifically, the investigators seek to examine the effects of music therapy on pain perception, stress levels, anxiety levels, and vital parameters (blood pressure, heart rate, and respiratory rate) during this procedure. The investigators hypothesize that music therapy can improve procedural comfort by reducing pain, stress, and anxiety.
This study employs quantitative multicenter research, specifically a randomized controlled trial (RCT), involving ICU patients at three hospitals: AZ Monica Deurne, GZA campus Sint-Augustinus, and Sint-Vincentius.
During the intervention, patients will listen to their preferred music through noise-canceling headphones. Patients will be able to select their preferred music.
To assess the effects of music therapy, the investigators developed a self-designed measurement tool, validated using content validation indices (CVI) with an expert panel including pain nurses. The tool measures various indicators, including:
Vital parameters: (arterial) blood pressure, heart rate, and respiratory rate
Pain perception: Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's pain level. Zero indicates no pain, while 10 represents the worst imaginable pain.
Anxiety and stress levels: Nurses will utilize 11-point Likert scales from 0 to 10 to measure the patient's anxiety and stress levels. The sum of these three scores will provide an overall measure of procedural distress.
To assess the duration of the effects of music therapy, we will record the above indicators at four time points:
Time 0: Ten minutes before sit-to-stand mobilization begins
Time 1: Ten minutes after sit-to-stand mobilization is completed
Time 2: Immediately before returning the patient to bed, after music stops
Time 3: Ten minutes after the patient is back in bed
Delta calculations will be performed to measure changes between time points.
The selected music playlist will be briefly noted on the measurement tool, and a final Likert scale will assess patient satisfaction with the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial (RCT) with parallel arms: control and intervention group. Not blinded.
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Device: MusicMusic through noise cancelling headphones. |
| No music | No intervention | –Control group receiving regular care. No music will be offered to the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- They are admitted to the ICU
- They have a Richmond Agitation-Sedation Scale (RASS) score of +1, 0, or -1
- They are able to speak Dutch
Key exclusion criteria (4 listed)
- They are younger than 18 years old
- They have a hearing impairment
- They are in isolation
- They have a cranial dressing or intracranial pressure monitoring
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 |
|---|---|---|
| MusicThe patient can decide the music genre (a standard playlist) and receives a noise-cancelling headphone playing the chosen music during mobilization. | Device | Music |
Primary outcome
pain perception level
Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's pain level
stress perception level
Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's stress level.
anxiety perception level
Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's anxiety level.
4 secondary outcomes
Time of mobilization
Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Blood pressure
Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Heart rate
Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Respiratory frequency
Time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Undecided. Data can be shared on request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Pain and Stress, run by Universiteit Antwerpen at 1 site in Belgium.
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 3 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 3 Jul 2024. 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 Belgium. 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 Lotte Heirbaut, RN (003232659169, lotte.heirbaut@student.uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain perception level (time frame: Ten minutes before mobilization begins and ten minutes after mobilization is completed). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2024.