Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Musical intervention and sensory isolation | Experimental | 30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes) |
|
| Sensory isolation | Active Comparator | Sensory isolation |
|
| Standard of care | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Musical intervention and sensory isolation | Behavioral | 30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes) |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan MESSIKA, MD | AP-HP Louis Mourier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Louis Mourier | Colombes | 92700 | France | |||
| CHD Vendée |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27618935 | Derived | Messika J, Hajage D, Panneckoucke N, Villard S, Martin Y, Renard E, Blivet A, Reignier J, Maquigneau N, Stoclin A, Puechberty C, Guetin S, Dechanet A, Fauquembergue A, Gaudry S, Dreyfuss D, Ricard JD. Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA). Trials. 2016 Sep 13;17(1):450. doi: 10.1186/s13063-016-1574-z. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| La Roche-sur-Yon |
| 85925 |
| France |
| Institut Gustave Roussy | Villejuif | 94800 | France |