Pilot Study: The Effects of Medical Music on Anxiety in Patients With ILD
|ClinicalTrials.gov Identifier: NCT04159584|
Recruitment Status : Completed
First Posted : November 12, 2019
Last Update Posted : January 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Lung Disease||Other: Medical Music||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is an uncontrolled, interventional pilot study to determine feasibility|
|Masking:||None (Open Label)|
|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|
Experimental: Enrolled Subject
All subjects will undergo the medical music intervention.
Other: Medical Music
Enrolled subjects will undergo 30 minutes of medical music listening
- 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 ]
- 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.
- 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").
- 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.
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159584
|United States, New York|
|Weill Cornell Medicine|
|New York, New York, United States, 10065|
|Principal Investigator:||Robert Kaner, MD||Weill Cornell Medicine|