Pilot Study: The Effects of Medical Music on Anxiety in Patients With ILD

Study Overview
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Brief Summary
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This is uncontrolled, interventional feasibility study for determining the effects medical music on anxiety levels in subjects with ILD. Enrolled subjects will be asked to complete questionnaires and undergo physiologic measurements prior to listening to medical music. The music intervention will be for approximately 30 minutes. Post intervention questionnaires and physiologic measurements will be done.

Detailed Description
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The Medical Music intervention includes playlists that contains songs specifically designed, recorded, and optimized through the provisionally-patented methods, to treat their co-morbid anxiety. The duration of the medical music playlist is 30 minutes. Enrolled subjects will be asked to complete questionnaires to assess anxiety, a questionnaire related to their music preferences, and undergo physiological measurements (vital signs, galvanic skin response, and heart rate variability) before and after the intervention.

Official Title
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Pilot Study: The Effects of Medical Music on Anxiety in Patients With Interstitial Lung Disease

Conditions
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Interstitial Lung Disease

Intervention / Treatment
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* Other: Medical Music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women age 50 to 80 years old Diagnosis of definite or probable interstitial lung disease (ILD) Willingness to participate and sign consent Exclusion Criteria: Patients who are deaf Inability to provide informed consent Pregnant women

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is an uncontrolled, interventional pilot study to determine feasibility
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enrolled Subject<br>All subjects will undergo the medical music intervention. | Other: Medical Music<br>* Enrolled subjects will undergo 30 minutes of medical music listening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of using a medical music intervention as a treatment for anxiety in subjects with ILD, as measured by descriptive evaluation. |  | Baseline to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in State Anxiety Inventory scores before and after intervention | The State-Trait Anxiety Inventory Questionnaire is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. It measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. | Baseline to 30 min | 
| Change in Visual Analogue Scale scores for Anxiety and Distress (VAS-A) before and after intervention | The VAS-A is a psychometric response scale to measure respondents level of anxiety and stress by indicating a position along a continuous line between two end-points (not at all to extremely). | Baseline to 30 min | 
| Change in Borg Dyspnea Scale scores before and after intervention | The Borg Dyspnea Scale measures perceived dyspnea on a scale from 0 to 10. | Baseline to 30 min | 
| Change in heart rate variability before and after intervention | Heart rate variability will be measured before and after intervention | Baseline to 30 min | 
| Change in galvanic skin response before and after intervention | Galvanic skin response will be measured before and after intervention | Baseline to 30 min |