Musical Intervention in Non-invasive Ventilation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Musical Intervention in the ICU: Effect on Tolerance and Acceptance of Non-invasive Ventilation

Conditions
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Respiratory Failure

Intervention / Treatment
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* Behavioral: Musical intervention and sensory isolation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Musical intervention and sensory isolation<br>30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes) | Behavioral: Musical intervention and sensory isolation<br>* 30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)<br>|
| Active Comparator: Sensory isolation<br>Sensory isolation | Behavioral: Musical intervention and sensory isolation<br>* 30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)<br>|
| No Intervention: Standard of care<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of respiratory discomfort during the 30 first minutes of NIV | Measure of respiratory discomfort at the beginning and the end of the first NIV session, with an analogic visual scale. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of respiratory parameters | Measure of respiratory rate | participants will be followed for the duration of hospital stay or maximum 28 days | 
| Evolution of respiratory parameters | Transcutaneous oxygen saturation | participants will be followed for the duration of hospital stay or maximum 28 days | 
| Evolution of respiratory parameters | Respiratory tidal volume | participants will be followed for the duration of hospital stay or maximum 28 days | 
| Number of NIV failure | NIV failure | participants will be followed for the duration of hospital stay or maximum 28 days | 
| Quality of life | Questionnaire | 3 months | 
| Evolution of cardiovascular parameters | Measure of heart rate | participants will be followed for the duration of hospital stay or maximum 28 days | 
| Evolution of cardiovascular parameters | Measure of blood pressure | participants will be followed for the duration of hospital stay or maximum 28 days | 
| Post traumatic stress disorder | questionnaire | 3 months | 
| overall assessment of NIV (in terms of discomfort, satisfaction, and trauma) | Questionnaire (scale) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIV, Respiratory failure, Musical intervention