Musical Intervention in Non-invasive Ventilation

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Behavioral: Musical intervention and sensory isolation

• Registration Number: NCT02265458
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-16
• Study Start: 2015-05
• Primary Completion: 2016-10
• Study Completion: 2017-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Musical intervention and sensory isolation	Musical intervention and sensory isolation	30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)
Sensory isolation	Musical intervention and sensory isolation	Sensory isolation

Primary Outcome Measures

Name	Time	Method
Variation of respiratory discomfort during the 30 first minutes of NIV	30 minutes	Measure of respiratory discomfort at the beginning and the end of the first NIV session, with an analogic visual scale.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Hôpital Louis Mourier; 🇫🇷 Colombes, France

CHD Vendée; 🇫🇷 La Roche Sur Yon, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France