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Completed

NCT Number: NCT02265458

Musical Intervention in 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.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Louis Mourier, Colombes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Musical intervention and sensory isolation

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Evolution of respiratory parameters

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

    Measure of respiratory rate

  2. Evolution of respiratory parameters

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

    Transcutaneous oxygen saturation

  3. Evolution of respiratory parameters

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

    Respiratory tidal volume

  4. Number of NIV failure

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

    NIV failure

  5. Quality of life

    Time frame: 3 months

    Questionnaire

  6. Evolution of cardiovascular parameters

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

    Measure of heart rate

  7. Evolution of cardiovascular parameters

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

    Measure of blood pressure

  8. Post traumatic stress disorder

    Time frame: 3 months

    questionnaire

  9. overall assessment of NIV (in terms of discomfort, satisfaction, and trauma)

    Time frame: 3 months

    Questionnaire (scale)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: Mus-IRA

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 16, 2014
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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