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

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

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Other: Medical Music

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enrolled Subject; All subjects will undergo the medical music intervention.	Other: Medical Music; Enrolled subjects will undergo 30 minutes of medical music listening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Neuralpositive

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): September 11, 2019
• Study Completion (Actual): September 11, 2019

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 1901019911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be available to the public upon request in a timely fashion.
• IPD Sharing Time Frame: 6 months after the publication
• IPD Sharing Access Criteria: De-identified data will be available to the public upon request in a timely fashion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No