Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Receiving mechanical ventilation in the intensive care unit (ICU)
You will not qualify if you...
- Children under 18 years old
- Deaf individuals
- Children over 18 years old
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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