NCT05602662

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Apr 2022Dec 2027

Study Start

First participant enrolled

April 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

4.8 years

First QC Date

October 27, 2022

Last Update Submit

February 10, 2026

Conditions

Music Therapy

Keywords

Music therapy, Ventilator treated patients, Need of sedation.

Outcome Measures

Primary Outcomes (1)

  • Changed dose of sedatives,

    Change of sedative treatment during mechanical ventilation.

    2 times one hour

Study Arms (2)

Music therapy during mechanical ventilation in the iCU.

EXPERIMENTAL

Headphones with music.

Behavioral: Music

Comparator

SHAM COMPARATOR

Headphones only.

Behavioral: Music

Interventions

MusicBEHAVIORAL

Music therapy during mechanical ventilation

ComparatorMusic therapy during mechanical ventilation in the iCU.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia & Intensive Care

Karlstad, Värmland County, 65181, Sweden

RECRUITING

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Ragnar N Henningsson, MD, PhD, Associate Professor

CONTACT

+46708707524ragnar.henningsson@regionvarmland.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 27, 2022

First Posted

November 2, 2022

Study Start

April 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations

SE(1)