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

January 11, 2018 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Colombes, France, 92700
        • Hopital Louis Mourier
      • La Roche Sur Yon, France, 85925
        • CHD Vendée
      • Villejuif, France, 94800
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of respiratory discomfort during the 30 first minutes of NIV
Time Frame: 30 minutes
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
Time Frame: participants will be followed for the duration of hospital stay or maximum 28 days
Measure of respiratory rate
participants will be followed for the duration of hospital stay or maximum 28 days
Evolution of respiratory parameters
Time Frame: participants will be followed for the duration of hospital stay or maximum 28 days
Transcutaneous oxygen saturation
participants will be followed for the duration of hospital stay or maximum 28 days
Evolution of respiratory parameters
Time Frame: participants will be followed for the duration of hospital stay or maximum 28 days
Respiratory tidal volume
participants will be followed for the duration of hospital stay or maximum 28 days
Number of NIV failure
Time Frame: participants will be followed for the duration of hospital stay or maximum 28 days
NIV failure
participants will be followed for the duration of hospital stay or maximum 28 days
Quality of life
Time Frame: 3 months
Questionnaire
3 months
Evolution of cardiovascular parameters
Time Frame: participants will be followed for the duration of hospital stay or maximum 28 days
Measure of heart rate
participants will be followed for the duration of hospital stay or maximum 28 days
Evolution of cardiovascular parameters
Time Frame: participants will be followed for the duration of hospital stay or maximum 28 days
Measure of blood pressure
participants will be followed for the duration of hospital stay or maximum 28 days
Post traumatic stress disorder
Time Frame: 3 months
questionnaire
3 months
overall assessment of NIV (in terms of discomfort, satisfaction, and trauma)
Time Frame: 3 months
Questionnaire (scale)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jonathan MESSIKA, MD, AP-HP Louis Mourier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimate)

October 16, 2014

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P131201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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