Pilot Study: The Effects of Medical Music on Anxiety in Patients With ILD
Primary Purpose
Interstitial Lung Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medical Music
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Lung Disease
Eligibility Criteria
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
Sites / Locations
- Weill Cornell Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enrolled Subject
Arm Description
All subjects will undergo the medical music intervention.
Outcomes
Primary Outcome Measures
Feasibility of using a medical music intervention as a treatment for anxiety in subjects with ILD, as measured by descriptive evaluation.
Secondary Outcome Measures
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.
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").
Change in Borg Dyspnea Scale scores before and after intervention
The Borg Dyspnea Scale measures perceived dyspnea on a scale from 0 to 10.
Change in heart rate variability before and after intervention
Heart rate variability will be measured before and after intervention
Change in galvanic skin response before and after intervention
Galvanic skin response will be measured before and after intervention
Full Information
NCT ID
NCT04159584
First Posted
October 22, 2019
Last Updated
January 29, 2020
Sponsor
Weill Medical College of Cornell University
Collaborators
Neuralpositive
1. Study Identification
Unique Protocol Identification Number
NCT04159584
Brief Title
Pilot Study: The Effects of Medical Music on Anxiety in Patients With ILD
Official Title
Pilot Study: The Effects of Medical Music on Anxiety in Patients With Interstitial Lung Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
September 11, 2019 (Actual)
Study Completion Date
September 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Neuralpositive
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an uncontrolled, interventional pilot study to determine feasibility
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enrolled Subject
Arm Type
Experimental
Arm Description
All subjects will undergo the medical music intervention.
Intervention Type
Other
Intervention Name(s)
Medical Music
Intervention Description
Enrolled subjects will undergo 30 minutes of medical music listening
Primary Outcome Measure Information:
Title
Feasibility of using a medical music intervention as a treatment for anxiety in subjects with ILD, as measured by descriptive evaluation.
Time Frame
Baseline to 30 minutes
Secondary Outcome Measure Information:
Title
Change in State Anxiety Inventory scores before and after intervention
Description
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.
Time Frame
Baseline to 30 min
Title
Change in Visual Analogue Scale scores for Anxiety and Distress (VAS-A) before and after intervention
Description
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").
Time Frame
Baseline to 30 min
Title
Change in Borg Dyspnea Scale scores before and after intervention
Description
The Borg Dyspnea Scale measures perceived dyspnea on a scale from 0 to 10.
Time Frame
Baseline to 30 min
Title
Change in heart rate variability before and after intervention
Description
Heart rate variability will be measured before and after intervention
Time Frame
Baseline to 30 min
Title
Change in galvanic skin response before and after intervention
Description
Galvanic skin response will be measured before and after intervention
Time Frame
Baseline to 30 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kaner, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Pilot Study: The Effects of Medical Music on Anxiety in Patients With ILD
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