Musical Intervention in the ICU: Effect on Tolerance and Acceptance of Non-invasive Ventilation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 114
- Locations
- 3
- Primary Endpoint
- Variation of respiratory discomfort during the 30 first minutes of NIV
Study Overview
Brief Summary
Non-invasive ventilation (NIV) might be associated with anxiety, thus leading to NIV failure, and intubation. Music therapy has been used in various clinical context, including in ICU patients under mechanical ventilation. We aim to evaluate the effect of a musical intervention on respiratory comfort during NIV for acute respiratory failure.
Detailed Description
We plan a randomized controlled trial with 3 different arms, in ICU patients requiring NIV for acute respiratory failure : "usual care", "sensory isolation" and "sensory isolation and musical intervention".At the onset of respiratory failure, each patient will be randomized in one of the 3 arms. "Usual care" assigned patients will receive NIV according to each unit protocol; "sensory isolation" assigned patients will receive NIV associated with a mask obscuring the eyes and a noise-reducing headset."musical intervention patients" will receive a 30 minutes musical intervention during each NIV session. Respiratory discomfort will be blindly assessed before, immediately after NIV is correctly set (5 minutes), at 30 minutes, and at hours 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 according to NIV session length, and at the end of NIV session during each NIV session.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •respiratory distress requiring NIV
- •Glasgow coma score above 12
Exclusion Criteria
- •NIV contraindication : Hemodynamic failure, neurologic failure, head trauma, vomiting
- •Severe hypoacusis people without hearing device
- •Decision to limit active treatment with an estimated life expectancy of less than 48 hours
Arms & Interventions
Musical intervention and sensory isolation
30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)
Intervention: Musical intervention and sensory isolation (Behavioral)
Sensory isolation
Sensory isolation
Intervention: Musical intervention and sensory isolation (Behavioral)
Standard of care
Standard of care
Outcomes
Primary Outcomes
Variation of respiratory discomfort during the 30 first minutes of NIV
Time Frame: 30 minutes
Measure of respiratory discomfort at the beginning and the end of the first NIV session, with an analogic visual scale.
Secondary Outcomes
- Evolution of respiratory parameters(participants will be followed for the duration of hospital stay or maximum 28 days)
- Evolution of cardiovascular parameters(participants will be followed for the duration of hospital stay or maximum 28 days)
- Quality of life(3 months)
- Post traumatic stress disorder(3 months)
- Number of NIV failure(participants will be followed for the duration of hospital stay or maximum 28 days)
- overall assessment of NIV (in terms of discomfort, satisfaction, and trauma)(3 months)