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

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Musical intervention and sensory isolation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Respiratory failure, NIV, Musical intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Louis Mourier
  • CHD Vendée
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Musical intervention and sensory isolation

Sensory isolation

Standard of care

Arm Description

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

Sensory isolation

Standard of care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evolution of respiratory parameters
Measure of respiratory rate
Evolution of respiratory parameters
Transcutaneous oxygen saturation
Evolution of respiratory parameters
Respiratory tidal volume
Number of NIV failure
NIV failure
Quality of life
Questionnaire
Evolution of cardiovascular parameters
Measure of heart rate
Evolution of cardiovascular parameters
Measure of blood pressure
Post traumatic stress disorder
questionnaire
overall assessment of NIV (in terms of discomfort, satisfaction, and trauma)
Questionnaire (scale)

Full Information

First Posted
August 25, 2014
Last Updated
January 11, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02265458
Brief Title
Musical Intervention in Non-invasive Ventilation
Acronym
Mus-IRA
Official Title
Musical Intervention in the ICU: Effect on Tolerance and Acceptance of Non-invasive Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Respiratory failure, NIV, Musical intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Musical intervention and sensory isolation
Arm Type
Experimental
Arm Description
30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)
Arm Title
Sensory isolation
Arm Type
Active Comparator
Arm Description
Sensory isolation
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Behavioral
Intervention Name(s)
Musical intervention and sensory isolation
Intervention Description
30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)
Primary Outcome Measure Information:
Title
Variation of respiratory discomfort during the 30 first minutes of NIV
Description
Measure of respiratory discomfort at the beginning and the end of the first NIV session, with an analogic visual scale.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Evolution of respiratory parameters
Description
Measure of respiratory rate
Time Frame
participants will be followed for the duration of hospital stay or maximum 28 days
Title
Evolution of respiratory parameters
Description
Transcutaneous oxygen saturation
Time Frame
participants will be followed for the duration of hospital stay or maximum 28 days
Title
Evolution of respiratory parameters
Description
Respiratory tidal volume
Time Frame
participants will be followed for the duration of hospital stay or maximum 28 days
Title
Number of NIV failure
Description
NIV failure
Time Frame
participants will be followed for the duration of hospital stay or maximum 28 days
Title
Quality of life
Description
Questionnaire
Time Frame
3 months
Title
Evolution of cardiovascular parameters
Description
Measure of heart rate
Time Frame
participants will be followed for the duration of hospital stay or maximum 28 days
Title
Evolution of cardiovascular parameters
Description
Measure of blood pressure
Time Frame
participants will be followed for the duration of hospital stay or maximum 28 days
Title
Post traumatic stress disorder
Description
questionnaire
Time Frame
3 months
Title
overall assessment of NIV (in terms of discomfort, satisfaction, and trauma)
Description
Questionnaire (scale)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan MESSIKA, MD
Organizational Affiliation
AP-HP Louis Mourier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
CHD Vendée
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27618935
Citation
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.
Results Reference
derived

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Musical Intervention in Non-invasive Ventilation

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