Psychophysiologic responses of mechanically ventilated patients to music: a pilot study.
L L Chlan
https://pubmed.ncbi.nlm.nih.gov/7787918/Actively Recruiting
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-04-09
178
Participants Needed
3
Research Sites
87 weeks
Total Duration
Researchers are evaluating the effects of live entrained music therapy on adult patients requiring mechanical ventilation in the intensive care unit ICU. This study focuses on patients with acute hypoxemic respiratory failure, acute hypercapnic respiratory failure, and acute respiratory distress syndrome ARDS. The goal is to assess whether live music therapy, tailored to the patients cultural preferences and synchronized with their vital signs, can reduce the duration of mechanical ventilation and improve related clinical outcomes. The study will enroll 178 adult patients on mechanical ventilation who will be randomly assigned to either a music therapy group or a control group, matched by diagnosis, age, gender, and co-morbidities. The music therapy involves a certified music therapist providing live music using techniques such as vocal toning, ocean drum with song melodies, song of kin with lyrics, processing patient experiences, and creating a harmonic sound environment. These interventions are designed to promote relaxation and comfort through interaction with the patient. Participants will be monitored for various clinical outcomes including the total time spent on mechanical ventilation, amount of sedation given, agitation and sedation levels, delirium, pain scores, and length of ICU and hospital stay. Vital signs such as respiration rate, heart rate, and oxygen saturation will be recorded at 15-minute intervals during the 30-minute music therapy sessions. The study will evaluate these measures over an average period of 14 days. The research aims to understand the impact of music therapy on these important health indicators in ICU patients.
CONDITIONS
The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
J
Joanne Loewy, DA, LCAT, MT-BC
C
Christopher Pizzute, MA, LCAT-LP, MT-BC
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Icahn School of Medicine at Mount Sinai
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Toning (Guided Vocalization & Breath Awareness) | Ocean Drum & Song of Kin Melody | Standard Supportive ICU Care (No Adjunctive Music Therapy) |
|---|---|---|---|
| What it is | A music therapy intervention involving gentle guided breathing, vocalization on an 'Ah' vowel (toning) to create resonance in the chest, with the patient encouraged to participate as comfortable. | A music therapy approach using an ocean drum to mimic breath sounds and humming the 'Song of Kin' melody, with interaction between therapist and patient for entrainment and calming effect. | Standard medical management in the ICU for patients on mechanical ventilation, which may include routine supportive therapies such as sedation, analgesia, and ventilator weaning, but does not include adjunctive music therapy. |
| Role in the trial | Investigational arm—participants randomized to receive toning music therapy to support comfort and respiratory awareness. | Investigational arm—participants randomized to the ocean drum and Song of Kin melody music therapy strategy. | Current practice arm (not part of trial); patients would receive standard ICU supportive care without adjunctive music therapy. |
| Primary use or purpose | To enhance breathing comfort, increase awareness of breath, and potentially support ventilation weaning through guided vocal music therapy. | To create relaxation and entrainment, reduce anxiety, and support respiratory comfort during mechanical ventilation using instrumental and vocal music. | To manage acute respiratory failure and optimize mechanical ventilation, sedation, and supportive measures without adjunctive therapies like music therapy. |
| How it is given or performed | A credentialed music therapist guides the session using vocalized 'Ah' tones, inviting patient participation as able. Provision occurs bedside in the ICU while the patient is ventilated. | A music therapist introduces the ocean drum and hums the Song of Kin melody, inviting the patient to hum along. All sessions take place in the ICU. | Medical/nursing staff provide continuous care in the ICU, utilizing ventilator protocols, sedation, and regular monitoring as dictated by patient need. |
| Evidence status | Music therapy for mechanically ventilated patients is supported by several small studies suggesting possible reductions in anxiety and physiological stress, but larger studies are needed to confirm effects on ventilation duration and weaning. | Music therapy involving live or instrumental music for ventilated ICU patients has shown reductions in anxiety and some physiologic markers in published studies, but randomized trial evidence remains limited. | Supportive ICU care without music therapy is standard and effective for the management of respiratory failure, but does not provide music's potential relaxation or anxiety-reducing benefits. |
| Important limitations | Evidence for music therapy's effect on classic ICU outcomes (such as ventilator duration or mortality) is limited; intervention can be challenging for patients with hearing impairment, sedation, or medical instability. | Specific instrumental music interventions may not be feasible in all ICU settings; lack of robust data limits conclusions about wider effectiveness. | Standard care does not explicitly target non-pharmacologic reduction of anxiety or distress from mechanical ventilation, which may leave some unmet needs. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days or until extubation
Participants receive music therapy sessions led by a certified music therapist involving breathing exercises, live music entrainment, and processing of their experience to support comfort while on mechanical ventilation.
Daily sessions during mechanical ventilation
Duration - Up to 14 days after treatment
Participants are monitored for clinical outcomes including sedation levels, agitation, delirium, pain, and length of ICU and hospital stay after the treatment period.
Daily assessments for up to 14 days
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
5
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https://pubmed.ncbi.nlm.nih.gov/24088092/Icahn School of Medicine at Mount Sinai
Lead Sponsor