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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159584
Recruitment Status : Completed
First Posted : November 12, 2019
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
Neuralpositive
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Other: Medical Music Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is an uncontrolled, interventional pilot study to determine feasibility
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: The Effects of Medical Music on Anxiety in Patients With Interstitial Lung Disease
Actual Study Start Date : April 15, 2019
Actual Primary Completion Date : September 11, 2019
Actual Study Completion Date : September 11, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Measures :
  1. Change in State Anxiety Inventory scores before and after intervention [ Time Frame: 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.

  2. Change in Visual Analogue Scale scores for Anxiety and Distress (VAS-A) before and after intervention [ Time Frame: 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").

  3. Change in Borg Dyspnea Scale scores before and after intervention [ Time Frame: Baseline to 30 min ]
    The Borg Dyspnea Scale measures perceived dyspnea on a scale from 0 to 10.

  4. Change in heart rate variability before and after intervention [ Time Frame: Baseline to 30 min ]
    Heart rate variability will be measured before and after intervention

  5. Change in galvanic skin response before and after intervention [ Time Frame: Baseline to 30 min ]
    Galvanic skin response will be measured before and after intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159584


Locations
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United States, New York
Weill Cornell Medicine
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Neuralpositive
Investigators
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Principal Investigator: Robert Kaner, MD Weill Cornell Medicine
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04159584    
Other Study ID Numbers: 1901019911
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be available to the public upon request in a timely fashion.
Time Frame: 6 months after the publication
Access Criteria: De-identified data will be available to the public upon request in a timely fashion.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases