Musical Intervention in Non-invasive Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Music Therapy During NIV Implantation in Pediatric Intensive Care Units

NCT06848218

Acute Respiratory Failure (ARF) Non Invasive Ventilation (NIV)

RECRUITING NA

The Impact of Receptive Music Therapy in the ICU

NCT03931733

Critical Illness

COMPLETED NA

The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU

NCT03642002

Acute Respiratory Distress Syndrome Acute Hypoxemic Respiratory Failure Acute Hypercapnic Respiratory Failure

RECRUITING NA

Effects of Live Music on the Perception of Noise in the SICU: A Patient, Caregiver, and Medical Staff Environmental Study

NCT02269527

Pain Anxiety Stress

COMPLETED NA

Musical Intervention on Stress Effects in Critically Ill Patients

NCT06120660

Critical Care Respiration, Artificial Sedation

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Musical intervention and sensory isolation

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

Group Type EXPERIMENTAL

Musical intervention and sensory isolation

Intervention Type BEHAVIORAL

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

Sensory isolation

Group Type ACTIVE_COMPARATOR

Musical intervention and sensory isolation

Intervention Type BEHAVIORAL

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

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Musical intervention and sensory isolation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No