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

NCT ID: NCT05602662

Last Updated: 2023-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Music Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Music therapy during mechanical ventilation in the iCU.

Headphones with music.

Group Type EXPERIMENTAL

Music

Intervention Type BEHAVIORAL

Music therapy during mechanical ventilation

Comparator

Headphones only.

Group Type SHAM_COMPARATOR

Music

Intervention Type BEHAVIORAL

Music therapy during mechanical ventilation

Interventions

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Music

Music therapy during mechanical ventilation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* Children \>18 years.
* Deaf people.
* Children \<18 Years
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karlstad Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ragnar Henningsson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesia & Intensive Care

Karlstad, Värmland County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Ragnar N Henningsson, MD, PhD, Associate Professor

Role: CONTACT

+46708707524

Facility Contacts

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Ragnar N Henningsson, Associate Professor

Role: primary

+46708707524

Sven Uhlig, MD, PhD

Role: backup

+4654617444

Other Identifiers

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KarlstadCH2

Identifier Type: -

Identifier Source: org_study_id

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