NCT02265458

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 16, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

August 25, 2014

Last Update Submit

January 11, 2018

Conditions

Respiratory Failure

Keywords

Respiratory failureNIVMusical intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Evolution of respiratory parameters

    participants will be followed for the duration of hospital stay or maximum 28 days

  • Evolution of respiratory parameters

    participants will be followed for the duration of hospital stay or maximum 28 days

  • Evolution of respiratory parameters

    participants will be followed for the duration of hospital stay or maximum 28 days

  • Number of NIV failure

    participants will be followed for the duration of hospital stay or maximum 28 days

  • Quality of life

    3 months

  • +4 more secondary outcomes

Study Arms (3)

Musical intervention and sensory isolation

EXPERIMENTAL

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

Behavioral: Musical intervention and sensory isolation

Sensory isolation

ACTIVE COMPARATOR

Sensory isolation

Behavioral: Musical intervention and sensory isolation

Standard of care

NO INTERVENTION

Standard of care

Interventions

Musical intervention and sensory isolationBEHAVIORAL

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

Musical intervention and sensory isolationSensory isolation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • respiratory distress requiring NIV
  • Glasgow coma score above 12

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Louis Mourier

Colombes, 92700, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Related Publications (1)

  • 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.

    PMID: 27618935DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Jonathan MESSIKA, MD

    AP-HP Louis Mourier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2014

First Posted

October 16, 2014

Study Start

May 1, 2015

Primary Completion

October 1, 2016

Study Completion

January 1, 2017

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

FR(3)