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

Interstitial Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04159584
• Other study ID #: 1901019911
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: September 11, 2019

Study information

• Verified date: January 2020
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 11, 2019
• Est. primary completion date: September 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Other:
• Medical Music
Enrolled subjects will undergo 30 minutes of medical music listening

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Neuralpositive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in heart rate variability before and after intervention	Heart rate variability will be measured before and after intervention	Baseline to 30 min
Secondary	Change in galvanic skin response before and after intervention	Galvanic skin response will be measured before and after intervention	Baseline to 30 min