Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
Healthy Volunteers
ID05602662

Music as a Complement to Pharmacological Sedation in Ventilator Treated ICU Patients - Prospective Randomized Cross-over Study

Led by Karlstad Central Hospital · Updated on 2026-02-12

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

K

Karlstad Central Hospital

Lead Sponsor

U

Uppsala University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether music therapy can reduce the need for medication sedation in adults who are receiving mechanical ventilation in the intensive care unit (ICU). The study compares the effects of music played through headphones with headphones alone in ventilated ICU patients. The goal is to observe changes in heart rate, blood pressure, respiratory rate, and the amount of sedative medication needed during treatment. Participants will be randomly assigned to one of two groups: one group will listen to music selected by a music therapist through headphones, while the other group will wear headphones without music. Each participant will have two sessions of one hour each over two days. This design allows researchers to assess the impact of music therapy compared to a control condition. During the study, 100 patients will be monitored for vital signs and sedative medication dosing. Data on heart rate, blood pressure, respiratory rate, and sedative dose changes will be collected during the two one-hour sessions. The study uses a double-blind method to ensure unbiased results. Participants' involvement includes wearing headphones as assigned and undergoing regular monitoring throughout the treatment sessions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Receiving mechanical ventilation in the intensive care unit (ICU)
Not Eligible

You will not qualify if you...

  • Children under 18 years old
  • Deaf individuals
  • Children over 18 years old

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Each treatment session lasts about 1 hour, repeated twice in a crossover design.

Participants receive music therapy or headphones only during mechanical ventilation in the ICU.

2 treatment sessions (in-person)

Trial Site Locations

Total: 1 location

1

Department of Anesthesia & Intensive Care

Karlstad, Värmland County, Sweden, 65181

Actively Recruiting

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Research Team

R

Ragnar N Henningsson, MD, PhD, Associate Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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