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

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.

Study Overview

• Status: Recruiting
• Conditions: Music Therapy
• Intervention / Treatment: Behavioral: Music

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ragnar N Henningsson, MD, PhD, Associate Professor; Phone Number: +46708707524; Email: ragnar.henningsson@regionvarmland.se

Study Locations

• Sweden
  • Värmland
    • Karlstad, Värmland, Sweden, 65181
      • Recruiting
      • Department of Anesthesia & Intensive Care
      • Contact: Ragnar N Henningsson, Associate Professor; Phone Number: +46708707524; Email: ragnar.henningsson@regionvarmland.se
      • Contact: Sven Uhlig, MD, PhD; Phone Number: +4654617444; Email: sven.uhlig@regionvarmland.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

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Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music therapy during mechanical ventilation in the iCU.; Headphones with music.	Behavioral: Music; Music therapy during mechanical ventilation
Sham Comparator: Comparator; Headphones only.	Behavioral: Music; Music therapy during mechanical ventilation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karlstad Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Music therapy, Ventilator treated patients, Need of sedation.
• Other Study ID Numbers: KarlstadCH2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No