StressNCT06442644
Live Music in the Intensive Care Unit
A study testing Live music in the intensive care unit in people with Stress and Pain, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The goal of this quasi-experimental pre- post test study is to test a patient-tailored live music intervention's effect on stress and pain reduction in adult, critically ill patients admitted to the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Live music in the intensive care unit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults (>18 years)
- Admitted to one of the four participating ICU departments for a minimum of 24 hours
- Able to read and speak Danish
- For incapable patients, it is necessary to have a close relative (e.g., spouse or adult child), as these will provide proxy consent for study participation
Who cannot join
- Unstable patients with a need of change/adjustment of the ongoing treatment of e.g. drug infusions or ventilator settings during the music intervention, as this can possibly affect the HRV measurements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Holm, post. doc contact
Denmark1 site
Aarhus University Hospital
Aarhus, Central Jutland, 8200
Linette Thorn, +4528917602, linlauri@rm.dk
About this study
The goal of this quasi-experimental pre- post test study is to test a patient-tailored live music intervention's effect on stress and pain reduction in adult, critically ill patients admitted to the intensive care unit.
The main question it aims to answer is:
Read more
- Does live music reduce stress and pain in adult intensive care patients?
In the pre-post test design, the patients will be their own control. There will be no randomisation. Researchers will compare measurements of heartrate, respiration rate, heartrate variability, blood pressure and pain before and after the live music intervention to see if live music effects these vital parameters.
Participants will listen to live music in their room in the intensive care unit for 5 to 15 minutes.
Read the detailed description
- Introduction The intensive care unit (ICU) has been and is still undergoing paradigmatic changes and technological advancements, meaning that an increased number of patients are conscious during their ICU stay and more survive to remember their ICU admission. Patients are admitted to the ICU because they are in urgent need of life saving treatments. However, an ICU admission can be a traumatic experience for patients and their relatives. The ICU patient room is designed with the purpose of promoting advanced care and treatment performed by the healthcare professionals. However, the room leaves little space for positive sensory inputs for the patients and the relatives; rather the environment is a highly technological, noisy, unfamiliar and often frightening experience for the patients and their relatives - memories of this may follow them for years. In this project, the investigators aim to test patient-tailored live music as an intervention to reduce stress and pain for adult ICU patients.
- Project aim The aim of this study is to test a patient-tailored live music intervention's effect on stress reduction in adult, critically ill patients admitted to the intensive care unit.
- Design and analysis method The study is a quasi-experimental pre- post test study, with patients being their own control. The pre-post test measurements will be carried out at predefined time points (5 minutes before and 5 minutes after the intervention). Our primary outcome, the HRV, will be measured continuously 5 minutes before the music intervention, during the whole intervention and 5 minutes after the intervention. There will be no randomisation. Relevant static calculations will be performed using Stata. Statistical analysis will be supported by a statistician at CONNECT (A data support centre for clinical and genomic data).
- Music intervention This study will be performed in collaboration with the Royal Academy of Music, Aarhus, Denmark (RAMA) and ICU departments across Central Denmark Region, Aarhus University Hospital being main investigator. The musicians have participated in a training programme after which they are able to carry out one-on-one patient-tailored music sessions for adult patients at the ICU carried out in the patient's room. Each music intervention comprises three components: 1) A prior briefing by the nurse on the patients' condition relevant for the musical practice 2) A patient-tailored live music session in the patient room and 3) A debriefing with the nurse. The musicians plan a programme for each intervention day, and the patients will therefore not have the opportunity to choose specific pieces of music. The musicians prepare a mix of relaxing, soothing, familiar and unknown music with low-pitched instruments, e.g., guitar and piano, in a slow tempo (60-80 beats per minute), with a predictable musical structure, rhythm, and tonality, as it has been shown that low-pitched and low-intensity music may be calming and may regulate arousal levels. The length of the music intervention will range from 5 to 15 minutes depending on how many music pieces the patient wants to listen to or based on the nurse's assessment of the patient's condition.
- Sample size Aarhus University Hospital is the main research centre, but the study is a multi-centre study with participation of the Regional Hospitals of Gødstrup, Horsens and Viborg; all have agreed to participate. The intervention is fully implemented at all hospitals. The sample size is calculated based on an estimated population of 1103, corresponding to the patients receiving the intervention at all four sites annually. The investigators have determined that a sample size of 202 is needed to estimate the effect with a confidence level of 95%, margin of error of 5% and population proportion of 80%. Patients will be included consecutively.
- Project organisation and feasibility As Aarhus University Hospital is the main study site and also the largest, the investigators will include the majority of patients. This means that the investigators will have a larger percentage of the total sample size than the regional hospitals. A project nurse will collect data at each site. The project group consists of one project nurse and one nurse manager at each site. Furthermore, the group consists of Professor in Nursing at Aarhus University Hospital Pia Dreyer, Associate Professor at The Royal Academy of Music (Aarhus/Aalborg) Margrethe Langer Bro, project nurse Linette Thorn and the main applicant. The results from this pretest-posttest study will be published in a peer-reviewed journal (e.g., Nursing in Critical Care). Results will also be presented at national and international conferences.
- Impact of the project Instead of being exposed to an unpleasant room with little opportunity to rest their minds, patients (together with their relatives) will be given the opportunity to experience positive, musical stimuli that bring pleasant experiences and memories, which may support the patients mental well-being and rehabilitation both in the short and long term. The project has the potential to be implemented in more ICU departments across Denmark and potentially also in a broad range of non-ICU hospital departments.
- Being tested
- Live music in the intensive care unit
- Keywords
- Intensive care unit, Live music, Quantitative, Stress, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live music in the intensive care unitOther
To test a patient-tailored live music intervention's effect on stress reduction in adult, critically ill patients admitted to the intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| Adult intensive care patients | Other | Live music interventions Receives: Other: Live music in the intensive care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heartrate variability
measured via the HeartMath Sensor, which is validated for measuring stress levels
Measured: baseline (10 minutes before listening to live music), during (5-15 minutes of listening to live music), after (10 minutes after listening to live music)
Secondary outcomes (5)
Heartrate
Heart beat per minut
Measured: baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)
The patient's subjective pain experience via a numerical ranking scale (NRS)
Monitoring pain on a scale of 0-10, where 0 is no pain and 10 is the worst pain imaginable
Measured: baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)
Patient's self-reported stress level measured by STAI (State-Trait Anxiety Inventory) a validated short version to measure the stress level.
Questionaire
Measured: baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)
Blood pressure
Mean arteriel blood pressure meassured by artery cannula
Measured: baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)
Respiration rate
Breaths per minut
Measured: baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region MidtJylland Denmark, Novo Nordisk A/S, The Royal Conservatory of Music
- Responsible party
- Principal investigator, Linette Thorn, Aarhus University Hospital
- Investigators
- Linette Thorn, Master, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442644
- Sponsor's protocol ID
- 1-10-72-66-24
- Status last verified
- Jun 2024
- First submitted
- 3 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Music in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06442644
- Acronym / sponsor ID
- 1-10-72-66-24
- Keywords
- Intensive care unit, Live music, Quantitative, Stress, Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Region MidtJylland Denmark, Novo Nordisk A/S, The Royal Conservatory of Music
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Jun 2024 (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.
The goal of this quasi-experimental pre- post test study is to test a patient-tailored live music intervention's effect on stress and pain reduction in adult, critically ill patients admitted to the intensive care unit.
The main question it aims to answer is:
- Does live music reduce stress and pain in adult intensive care patients?
In the pre-post test design, the patients will be their own control. There will be no randomisation. Researchers will compare measurements of heartrate, respiration rate, heartrate variability, blood pressure and pain before and after the live music intervention to see if live music effects these vital parameters.
Participants will listen to live music in their room in the intensive care unit for 5 to 15 minutes.
Detailed description
- Introduction The intensive care unit (ICU) has been and is still undergoing paradigmatic changes and technological advancements, meaning that an increased number of patients are conscious during their ICU stay and more survive to remember their ICU admission. Patients are admitted to the ICU because they are in urgent need of life saving treatments. However, an ICU admission can be a traumatic experience for patients and their relatives. The ICU patient room is designed with the purpose of promoting advanced care and treatment performed by the healthcare professionals. However, the room leaves little space for positive sensory inputs for the patients and the relatives; rather the environment is a highly technological, noisy, unfamiliar and often frightening experience for the patients and their relatives - memories of this may follow them for years. In this project, the investigators aim to test patient-tailored live music as an intervention to reduce stress and pain for adult ICU patients.
- Project aim The aim of this study is to test a patient-tailored live music intervention's effect on stress reduction in adult, critically ill patients admitted to the intensive care unit.
- Design and analysis method The study is a quasi-experimental pre- post test study, with patients being their own control. The pre-post test measurements will be carried out at predefined time points (5 minutes before and 5 minutes after the intervention). Our primary outcome, the HRV, will be measured continuously 5 minutes before the music intervention, during the whole intervention and 5 minutes after the intervention. There will be no randomisation. Relevant static calculations will be performed using Stata. Statistical analysis will be supported by a statistician at CONNECT (A data support centre for clinical and genomic data).
- Music intervention This study will be performed in collaboration with the Royal Academy of Music, Aarhus, Denmark (RAMA) and ICU departments across Central Denmark Region, Aarhus University Hospital being main investigator. The musicians have participated in a training programme after which they are able to carry out one-on-one patient-tailored music sessions for adult patients at the ICU carried out in the patient's room. Each music intervention comprises three components: 1) A prior briefing by the nurse on the patients' condition relevant for the musical practice 2) A patient-tailored live music session in the patient room and 3) A debriefing with the nurse. The musicians plan a programme for each intervention day, and the patients will therefore not have the opportunity to choose specific pieces of music. The musicians prepare a mix of relaxing, soothing, familiar and unknown music with low-pitched instruments, e.g., guitar and piano, in a slow tempo (60-80 beats per minute), with a predictable musical structure, rhythm, and tonality, as it has been shown that low-pitched and low-intensity music may be calming and may regulate arousal levels. The length of the music intervention will range from 5 to 15 minutes depending on how many music pieces the patient wants to listen to or based on the nurse's assessment of the patient's condition.
- Sample size Aarhus University Hospital is the main research centre, but the study is a multi-centre study with participation of the Regional Hospitals of Gødstrup, Horsens and Viborg; all have agreed to participate. The intervention is fully implemented at all hospitals. The sample size is calculated based on an estimated population of 1103, corresponding to the patients receiving the intervention at all four sites annually. The investigators have determined that a sample size of 202 is needed to estimate the effect with a confidence level of 95%, margin of error of 5% and population proportion of 80%. Patients will be included consecutively.
- Project organisation and feasibility As Aarhus University Hospital is the main study site and also the largest, the investigators will include the majority of patients. This means that the investigators will have a larger percentage of the total sample size than the regional hospitals. A project nurse will collect data at each site. The project group consists of one project nurse and one nurse manager at each site. Furthermore, the group consists of Professor in Nursing at Aarhus University Hospital Pia Dreyer, Associate Professor at The Royal Academy of Music (Aarhus/Aalborg) Margrethe Langer Bro, project nurse Linette Thorn and the main applicant. The results from this pretest-posttest study will be published in a peer-reviewed journal (e.g., Nursing in Critical Care). Results will also be presented at national and international conferences.
- Impact of the project Instead of being exposed to an unpleasant room with little opportunity to rest their minds, patients (together with their relatives) will be given the opportunity to experience positive, musical stimuli that bring pleasant experiences and memories, which may support the patients mental well-being and rehabilitation both in the short and long term. The project has the potential to be implemented in more ICU departments across Denmark and potentially also in a broad range of non-ICU hospital departments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult intensive care patients | Other | Other: Live music in the intensive care unitLive music interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (>18 years)
- Admitted to one of the four participating ICU departments for a minimum of 24 hours
- Able to read and speak Danish
- For incapable patients, it is necessary to have a close relative (e.g., spouse or adult child), as these will provide proxy consent for study participation
Key exclusion criteria (1 listed)
- Unstable patients with a need of change/adjustment of the ongoing treatment of e.g. drug infusions or ventilator settings during the music intervention, as this can possibly affect the HRV measurements.
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 |
|---|---|---|
| Live music in the intensive care unitTo test a patient-tailored live music intervention's effect on stress reduction in adult, critically ill patients admitted to the intensive care unit. | Other | Adult intensive care patients |
Primary outcome
Heartrate variability
Time frame: baseline (10 minutes before listening to live music), during (5-15 minutes of listening to live music), after (10 minutes after listening to live music)
measured via the HeartMath Sensor, which is validated for measuring stress levels
5 secondary outcomes
Heartrate
Time frame: baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)
The patient's subjective pain experience via a numerical ranking scale (NRS)
Time frame: baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)
Patient's self-reported stress level measured by STAI (State-Trait Anxiety Inventory) a validated short version to measure the stress level.
Time frame: baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)
Blood pressure
Time frame: baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)
Respiration rate
Time frame: baseline (5 minutes before listening to live music), after (5 minutes after listening to live music)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Anna Holm, post. doc contact
Linette Thorn, Master principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live music in the intensive care unit in people with Stress and Pain, run by Aarhus University Hospital at 1 site in Denmark.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 4 Jun 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linette Thorn, Master (+0045 28917602, linlauri@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heartrate variability (time frame: baseline (10 minutes before listening to live music), during (5-15 minutes of listening to live music), after (10 minutes after listening to live music)). 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 4 Jun 2024.