Musical Intervention in Non-invasive Ventilation (Mus-IRA)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Respiratory Failure

Treatments: Behavioral: Musical intervention and sensory isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT02265458

P131201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 3 patient groups

Musical intervention and sensory isolation

Experimental group

Description:

30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)

Treatment:

Behavioral: Musical intervention and sensory isolation

Sensory isolation

Active Comparator group

Description:

Sensory isolation

Treatment:

Behavioral: Musical intervention and sensory isolation

Standard of care

No Intervention group

Description:

Standard of care