Music as a Complement to Pharmacological Sedation in Vent... | NCT05602662

Studies
Music as a Complement to Pharmacological Sedation in Ventilator Treated ICU Patients.

NCT05602662

Sponsor

Karlstad Central Hospital

Status

Recruiting

Last Update Posted

Feb 12, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Music Therapy

Interventions

Music

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Oct 27, 2022

First Submission Date that Met QC Criteria

Oct 27, 2022

First Posted Date

Nov 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2026

Last Update Posted Date

Feb 12, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ragnar Henningsson, Associate Professor, Karlstad Central HospitalPrincipal Investigator

Lead Sponsor

Karlstad Central HospitalOTHER

Collaborators

Name	Class
Uppsala University Hospital	OTHER
University Hospital of Gothenburg Sweden	UNKNOWN
Central Hospital of Gävle, Sweden	UNKNOWN
Central Hospital of Falun Sweden

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Music therapy during mechanical ventilation in the iCU.	Experimental	Headphones with music.	Behavioral: Music
Comparator	Sham Comparator	Headphones only.	Behavioral: Music

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Music	Behavioral	Music therapy during mechanical ventilation	Comparator Music therapy during mechanical ventilation in the iCU.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changed dose of sedatives,	Change of sedative treatment during mechanical ventilation.	2 times one hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: In the ICU, entilator treated adults > 18 years.

Exclusion Criteria:

Children >18 years.
Deaf people.
Children <18 Years

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ragnar N Henningsson, MD, PhD, Associate Professor	Contact	+46708707524		ragnar.henningsson@regionvarmland.se

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesia & Intensive Care	Recruiting	Karlstad	Värmland County	65181	Sweden

Intervention Browse Module

MeSH Terms

ID	Term
D009147	Music Therapy

Ancestor Terms

ID	Term
D026421	Sensory Art Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided