Musical Intervention in Non-invasive Ventilation

Respiratory Failure Clinical Trial

— Mus-IRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265458
• Other study ID #: P131201
• Status: Completed
• Phase: N/A
• First received: August 25, 2014
• Last updated: January 11, 2018
• Start date: May 2015
• Est. completion date: January 2017

Study information

• Verified date: January 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Louis Mourier	Colombes
France	CHD Vendée	La Roche Sur Yon
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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