Overview

This trial is active, not recruiting.

Condition respiratory failure
Treatment musical intervention and sensory isolation
Sponsor Assistance Publique - Hôpitaux de Paris
Start date May 2015
End date September 2016
Trial size 114 participants
Trial identifier NCT02265458, P131201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)
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
musical intervention and sensory isolation
30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)
(No Intervention)
Standard of care

Primary Outcomes

Measure
Variation of respiratory discomfort during the 30 first minutes of NIV
time frame: 30 minutes

Secondary Outcomes

Measure
Evolution of respiratory parameters
time frame: 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
Evolution of respiratory parameters
time frame: 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
Quality of life
time frame: 3 months
Evolution of cardiovascular parameters
time frame: 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
Post traumatic stress disorder
time frame: 3 months
overall assessment of NIV (in terms of discomfort, satisfaction, and trauma)
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Musical Intervention in the ICU: Effect on Tolerance and Acceptance of Non-invasive Ventilation
Principal investigator Jonathan MESSIKA, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.