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

• Sponsor: Karlstad Central Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05602662
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Music Therapy	Behavioral: Music	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Music as a Complement to Pharmacological Sedation in Ventilator Treated ICU Patients - Prospective Randomized Cross-over Study.
• Actual Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changed dose of sedatives, [2 times one hour]

   Change of sedative treatment during mechanical ventilation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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Exclusion Criteria:

• Children >18 years.

• Deaf people.

• Children <18 Years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesia & Intensive Care	Karlstad	Värmland	Sweden	65181

Sponsors and Collaborators

• Karlstad Central Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ragnar Henningsson, Associate Professor, Karlstad Central Hospital
• ClinicalTrials.gov Identifier: NCT05602662
• Other Study ID Numbers: KarlstadCH2
• First Posted: Nov 2, 2022
• Last Update Posted: Nov 14, 2022
• Last Verified: Nov 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ragnar Henningsson, Associate Professor, Karlstad Central Hospital: Music therapy, Ventilator treated patients, Need of sedation.

Study Results

No Results Posted as of Nov 14, 2022