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

Not Applicable

Completed

• Conditions: Interstitial Lung Disease
• Interventions: Other: Medical Music

• Registration Number: NCT04159584
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-04-15
• Primary Completion: 2019-09-11
• Study Completion: 2019-09-11
• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enrolled Subject	Medical Music	All subjects will undergo the medical music intervention.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in State Anxiety Inventory scores before and after intervention	Baseline to 30 min	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.
Change in heart rate variability before and after intervention	Baseline to 30 min	Heart rate variability will be measured before and after intervention
Change in Visual Analogue Scale scores for Anxiety and Distress (VAS-A) before and after intervention	Baseline to 30 min	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").
Change in Borg Dyspnea Scale scores before and after intervention	Baseline to 30 min	The Borg Dyspnea Scale measures perceived dyspnea on a scale from 0 to 10.
Change in galvanic skin response before and after intervention	Baseline to 30 min	Galvanic skin response will be measured before and after intervention

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States