Music TherapyNCT05602662
Music as a Complement to Pharmacological Sedation in Ventilator Treated ICU Patients.
A study testing Music in people with Music Therapy, run by Karlstad Central Hospital at 1 site in Sweden.
Trial summary
Can music theraphy during mechanical ventilation in the ICU, decrease the need of pharmacological sedation? Included patients will listen to music selected by a music therapist via headphones two times one hour during two days. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Music Therapy
- What is being tested?
- Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2022to 31 Dec 2027
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Children >18 years.
- Deaf people.
- Children <18 Years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ragnar N Henningsson, MD, PhD, Associate Professor contact
Sweden1 site, 1 recruiting
- Recruiting
Department of Anesthesia & Intensive Care
Karlstad, Värmland County, 65181
Ragnar N Henningsson, Associate Professor, +46708707524, ragnar.henningsson@regionvarmland.se
Sven Uhlig, MD, PhD, +4654617444, sven.uhlig@regionvarmland.se
About this study
Official title: Music as a Complement to Pharmacological Sedation in Ventilator Treated ICU Patients - Prospective Randomized Cross-over Study.
Can music theraphy during mechanical ventilation in the ICU, decrease the need of pharmacological sedation? Included patients will listen to music selected by a music therapist via headphones two times one hour during two days. Effects on heart rate, blood pressure, respiratory rate and dosing of pharmacological sedation will be observed. 100 patients will be included and radomized equally to earphones with and without music.
- Conditions
- Music Therapy
- Being tested
- Music
- Keywords
- Music therapy, Ventilator treated patients, Need of sedation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
Music therapy during mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| Music therapy during mechanical ventilation in the iCU. | Experimental | Headphones with music. Receives: Behavioral: Music |
| Comparator | Sham comparator | Headphones only. Receives: Behavioral: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changed dose of sedatives,
Change of sedative treatment during mechanical ventilation.
Measured: 2 times one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music TherapyStudies 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
- Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karlstad Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital, University Hospital of Gothenburg Sweden, Central Hospital of Gävle, Sweden, Central Hospital of Falun Sweden, University Hospital of Örebro Sweden
- Responsible party
- Principal investigator, Ragnar Henningsson, Karlstad Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602662
- Sponsor's protocol ID
- KarlstadCH2
- Status last verified
- Feb 2026
- First submitted
- 27 Oct 2022
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music as a Complement to Pharmacological Sedation in Ventilator Treated ICU Patients - Prospective Randomized Cross-over Study.
- ClinicalTrials.gov ID
- NCT05602662
- Acronym / sponsor ID
- KarlstadCH2
- Conditions
- Music Therapy
- Keywords
- Music therapy, Ventilator treated patients, Need of sedation.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karlstad Central HospitalUniversity, hospital or other
- Collaborators
- Uppsala University Hospital, University Hospital of Gothenburg Sweden, Central Hospital of Gävle, Sweden, Central Hospital of Falun Sweden, University Hospital of Örebro Sweden
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Nov 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.
Can music theraphy during mechanical ventilation in the ICU, decrease the need of pharmacological sedation? Included patients will listen to music selected by a music therapist via headphones two times one hour during two days. Effects on heart rate, blood pressure, respiratory rate and dosing of pharmacological sedation will be observed. 100 patients will be included and radomized equally to earphones with and without music.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music therapy during mechanical ventilation in the iCU. | Experimental | Behavioral: MusicHeadphones with music. |
| Comparator | Sham comparator | Behavioral: MusicHeadphones only. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Children >18 years.
- Deaf people.
- Children <18 Years
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 |
|---|---|---|
| MusicMusic therapy during mechanical ventilation | Behavioural | Comparator, Music therapy during mechanical ventilation in the iCU. |
Primary outcome
Changed dose of sedatives,
Time frame: 2 times one hour
Change of sedative treatment during mechanical ventilation.
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 12 Feb 2026.
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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.
Ragnar N Henningsson, MD, PhD, Associate Professor contact
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 Music Therapy, run by Karlstad Central Hospital at 1 site in Sweden.
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 0 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 12 Feb 2026. 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 Sweden. 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. Some participants in this study may receive a placebo. 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 Ragnar N Henningsson, MD, PhD, Associate Professor (+46708707524, ragnar.henningsson@regionvarmland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changed dose of sedatives, (time frame: 2 times one hour). 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 12 Feb 2026.